Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in Primary Care: Active legs RCT.
TITLE
Authors
Present Address:
BorjaHerraiz-Ahijado1,2,3,4,5✉Emailborjajesus.herraiz@salud.madrid.org
CarmenFolguera-Álvarez2,3,4,6
RicardoRodríguez-Barrientos2,3,7
RaquelSánchez-Ruano2,3,7
MarcosPascual-García7,11
PilarMori-Vara4,9
JoséVerdú-Soriano10
MilagrosRico-Blázquez2,3,4,7,8
Dr
AraceliRivera-Álvarez1MendiguchíaCarriche1
Prado.
EstherGonzález12BeatrizNavarro-Mallen13
JoseDavid.Arroyo-Romero13
El13
BorjaJesús14
HerraizAhijado.RN14
1Dos de Mayo Healthcare Center. Primary Care Assistance ManagementMadrid Health ServiceMadridSpain
2Research Network on Chronicity, Primary Care and Health Promotion (RICORS- RICAPPS)Instituto de Salud Carlos IIIMadridSpain
3Gregorio Marañon Health Research Institute, Madrid Health ServiceMadridSpain
4Nursing Department, Faculty of Nursing, Physiotherapy and PodiatryUniversidad Complutense de MadridMadridSpain
5Doctoral Program in “Cuidados en Salud”Universidad Complutense de MadridMadridSpain
6La Paz Healthcare Center. Primary Care Assistance ManagementMadrid Health ServiceRivas-VaciamadridSpain
7Research Unit. Primary Care Assistance ManagementMadrid Health ServiceMadridSpain
8Research Group on Public Health - Lifestyles, nursing methodology and care in the community environmentUniversidad Complutense de MadridMadridSpain
9Health Innovation Research Group, Nursing Department, Faculty of Nursing, Physiotherapy and PodiatryUniversidad Complutense de MadridMadridSpain
10Departamento de Enfermería Comunitaria, Salud Pública e Historia de la Ciencia, Facultad de Ciencias de la SaludUniversidad de AlicanteSan Vicente del RaspeigMedicina Preventiva, AlicanteEspaña
11Alpes Healthcare Center. Primary Care Assistance ManagementMadrid Health ServiceMadridSpain
12
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Remedios Laguna-Prados. Pacífico Healthcare centerNumancia Healthcare center: Beatriz Valdivielso- Fernandez-de-Valderrama, David Villamañan-LoboBelén Peláez-Raposo. Paracuellos del Jarama Healthcare center: María Jesús Calvo-Martínez13Marta Berrocal-García. Colmenar de Oreja Healthcare, María José Hita-Urias
14Centro de Salud Dos de Mayo. Gerencia Asistencial de Atención PrimariaServicio Madrileño de Salud. Calle Coronel de Palma 128934Móstoles, Madrid
Borja Herraiz-Ahijado1,2,3,4,5, Carmen Folguera-Álvarez2,3,4,6, Ricardo Rodríguez-Barrientos2,3,7, Raquel Sánchez-Ruano2,3,7, Marcos Pascual-García 7,11, Pilar Mori-Vara4,9, José Verdú-Soriano10, Active legs group12 and Milagros Rico-Blázquez2,3,4,7,8.
Authors’ affiliations
1. Dos de Mayo Healthcare Center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
2. Research Network on Chronicity, Primary Care and Health Promotion (RICORS-RICAPPS). Instituto de Salud Carlos III, Madrid, Spain.
3. Gregorio Marañon Health Research Institute, Madrid Health Service, Madrid, Spain.
4. Nursing Department. Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.
5. PhD student. Doctoral Program in “Cuidados en Salud”, Universidad Complutense de Madrid, Madrid, Spain.
6. La Paz Healthcare Center. Primary Care Assistance Management, Madrid Health Service, Rivas-Vaciamadrid, Spain.
7. Research Unit. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
8. Research Group on Public Health - Lifestyles, nursing methodology and care in the community environment. Universidad Complutense de Madrid, Madrid, Spain.
9. Health Innovation Research Group. Nursing Department. Faculty of Nursing, Physiotherapy and Podiatry. Universidad Complutense de Madrid, Madrid, Spain.
10. Departamento de Enfermería Comunitaria, Medicina Preventiva, Salud Pública e Historia de la Ciencia, Facultad de Ciencias de la Salud, Universidad de Alicante, San Vicente del Raspeig, Alicante, España.
11. Alpes Healthcare Center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
12. Abrantes Healthcare center: Araceli Rivera-Álvarez. Dr Mendiguchía Carriche Healthcare center: Alberto López-García-Franco, Belén Pose-García, Juan Carlos García-Álvarez, Julia de-las-Pozas-Abril, Rocío López-Sánchez, Rocío Muñoz-Caballero. Jaime Vera Healthcare center: Mónica Rodríguez-Vegue. La Paz Healthcare center: Layla El-Jundi-Carrasco. Martín de Vargas Healthcare center: Esther González-Prado. Numancia Healthcare center: Beatriz Valdivielso-Fernandez-de-Valderrama, Remedios Laguna-Prados. Pacífico Healthcare center: Belén Peláez-Raposo. Paracuellos del Jarama Healthcare center: María Jesús Calvo-Martínez, Pilar Lebracón-Cortés. Paseo Imperial Healthcare center: Virginia Prado-Fidalgo. Pavones Healthcare center: David Villamañan-Lobo. Villa de Vallecas Healthcare center: Beatriz Navarro-Mallen, Jose David Arroyo-Romero. El Molar Healthcare center: Marta Berrocal-García. Colmenar de Oreja Healthcare center: María José Hita-Urias.
Corresponding author
Borja Jesús Herraiz Ahijado. RN.
Address: Centro de Salud Dos de Mayo. Gerencia Asistencial de Atención Primaria. Servicio Madrileño de Salud. Calle Coronel de Palma 1. 28934 Móstoles, Madrid.
e-mail address: borjajesus.herraiz@salud.madrid.org
ORCID Identifier: 0000-0002-3399-6188 ResearcherID: C-3005-2019
ABSTRACT
Background
Venous ulcers negatively affect quality of life and generate high health care costs. Physical activity may improve their evolution; however, the evidence is limited and heterogeneous.
Objective
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To evaluate the effectiveness of a structured physical activity intervention as an adjunct treatment for the complete healing of venous ulcers in primary care at 3 and 6 months of follow-up. Design: This was a randomized, pragmatic clinical trial with 6 months of follow-up.Methods
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Between February 2021 and June 2023, 44 people with a diagnosis of venous ulcers and an ankle-brachial index between 0.8 and 1.3 were recruited from 13 health centres in Madrid. Both groups received standard treatment. A
The intervention group also received a structured educational intervention of physical exercise and daily walking guidelines. The main outcomes were complete healing (RESVECH 2.0 scale) and time to healing (days). The secondary variables included degree of healing, ulcer area, pain, adherence, and variables related to healing and prognosis. Data were collected at the beginning and at 3 and 6 months of follow-up. Survival analysis (Kaplan‒Meier and Cox) was performed to measure the effectiveness of the treatments, as was intention-to-treat analysis.Results
At 3 months, 77.3% [95% CI 54–91] of the patients in the intervention group and 68.2% [95% CI 45–85] of those in the control group achieved complete healing, without statistically significant differences between groups. Overall adherence to the intervention was low; only 20% and 46% of the participants reached the level of compliance established in the first two visits, which progressively decreased.
Conclusions
The Active Legs programme showed a positive effect on the healing of venous ulcers in primary care.
Trial registration:
A
NCT04039789. [https://ClinicalTrials.gov]. 11/07/2019.KEYWORDS
Varicose Ulcer
RCT
Complete Healing
Exercise
Nursing
Primary Health Care
Quality of Life
Ageing.
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BACKGROUND
Venous ulcers (VUs) are lesions with substance loss between the knee and the ankle secondary to chronic venous insufficiency (1–3), with a tendency towards torpid evolution, a slight tendency towards spontaneous healing(4) and a high recurrence rate(5).
Currently, VUs represent between 75% and 80% of all lower limb (LL) ulcers (6). In Spain, the prevalence of VUs is between 0.5% and 0.8% in the population, tripling to 3–5% in people over 65 years of age (6). Within the primary care setting, VUs account for 2.5% of the consultations, and more than 80% of patients receive treatment at this level of care, which is highly important in the treatment and diagnosis of this pathology (7, 8). In a 2007 study in Spain (9), the costs of dressing changes, infection episodes and hospital stays were collected, and the total cost of chronic wounds was estimated to account for between 1.5% and 3% of all health care costs.
VUs causes pain, bad odour, abundant exudate and sometimes infection, which can lead to mobility problems, sleep disorders, loss of vitality and functional dependence, negatively affecting quality of life and emotional well-being (10–12) .
The usual care of VUs includes cleaning, debridement, control of exudate with dressings (5, 13, 14) and multicomponent compression therapy for the control of chronic venous insufficiency (5, 6, 15–17).
Recent studies have indicated that LL muscle pump dysfunction (3, 18–22) and reduced ankle range of motion contribute to the low healing rate in these patients (23, 24). In addition, an insufficient level of physical activity has been observed in this population (25).
Evidence suggests that daily walking and physical exercise programs improve muscle pump function (26–29), healing rates (3, 18–22, 30–32), quality of life (3, 22, 30) and ankle joint mobility (23, 24). However, these studies have methodological limitations, such as small sample sizes, reduced follow-ups and great variability in the measurement instruments used.
Four recent systematic reviews have recommended the incorporation of physical exercise as a complement to compression therapy to improve healing, muscle strength, mobility and adherence to treatment (33–36).
The exercise programmes described include plantar flexion–extension, ankle twists, knee flexion–extension exercises, resistance exercises and ambulation, with face-to-face, home or combined modalities, some with technological support (3, 18–24, 26–32). Additionally, the use of pedometers has been shown to be helpful in promoting physical activity through personalized goals and ongoing feedback (37, 38).
We did not find studies in Spain that evaluated the effect of physical exercise on VU healing in primary care.
METHODS
Objectives:
To evaluate the effectiveness of a structured physical activity intervention (the Active Legs programme) as an adjunct treatment for the complete healing of Vus in primary care at 3 and 6 months of follow-up. As secondary objectives, the effects of the intervention on the rate of complete healing, the degree of healing and adherence to the intervention at 3 and 6 months of follow-up were analysed.
Design and setting:
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This was a randomized, multicentre, pragmatic, open clinical trial with two parallel groups and 6 months of follow-up. The CONSORT checklist is available as supporting information (Additional file 1). The study methodology is presented in more detail in the published protocol (39).Setting and study population:
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The study was conducted in 13 primary care health centres in the Madrid region. A
People aged 18 years or older with a diagnosis of VUs recorded in electronic medical records and an ankle brachial index (ABI) between 0.8 and 1.3 and who were undergoing follow-up in a primary care nurse consultation and signed an informed consent form were included.People with arteriovenous ulcers, acute phase deep vein thrombosis, decompensated heart failure, acute dermatitis, rheumatoid arthritis, and antineoplastic treatment or those with absolute contraindications to physical exercise were excluded.
Between February 2021 and June 2023, 21 nurses who participated voluntarily in the study, recommended 64 people for participation in the study. Nine were excluded because they did not meet the inclusion criteria, and 11 refused to participate. Ultimately, 44 people were included and randomized into two groups (22 per branch). Figure 1 shows a flowchart of participant recruitment [Figure 1. Participant recruitment flow chart].
Fig. 1
Participant recruitment flow chart
Randomization and masking:
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Nurses consecutively recruited the participants during consultations and requested their written informed consent before being included in the study. Randomization was carried out by means of simple randomization, generated automatically by the Electronic Data Collection Notebook (CRDe).Given the type of intervention, it was not possible to blind either participants or professionals. However, the research team that performed the analysis was unaware of the group assignments.
Sample size:
The study was designed with a power of 80% and an alpha error of 0.05 to detect a minimum difference of 20% in people with complete healing at 3 months of follow-up. The calculated size was 224 people (112 per group), assuming a 20% loss to follow-up (3, 26, 30).
Interventions
In both groups, nurses performed the usual venous wound care, following the recommendations for the treatment of skin ulcers of the Madrid Health Service (2); care consisted of assessment, cleaning, antisepsis, debridement, treatment in a humid environment with dressings and multicomponent compression therapy.
The intervention group received, in addition to the usual treatment, information about “Active Legs”, a structured physical activity programme designed as an adjuvant to the usual treatment. This intervention was introduced to the participants by the nurses using health education techniques and included four progressive lower limb exercises to be performed twice a day at least five days a week in their homes.
Progressive daily ambulation was also recommended until the goal of 30 minutes a day, five days a week, was reached (40).
The participants received a printed "guide of recommendations for patients with venous ulcers of the Community of Madrid", and the people in the intervention group also received a Yamax™ PZ270 pedometer and an activity diary with activity guidelines and self-registration tables.
All the nurses received training in good practices and 2-hour training in Active Legs prior to the start of the study.
The intervention is described graphically and in detail in the published protocol (39).
Data collection and outcomes
The main outcome was complete ulcer healing at 3 months (yes/no), which was considered total epithelialization maintained for at least 2 weeks. The time elapsed between the beginning of the study and complete healing (in days) was also recorded. The secondary variables included complete healing at 6 months (yes/no), degree of healing (Resvech 2.0) (41), ulcer area (cm2) measured by digital photography (42), pain, prognostic and sociodemographic variables and adherence to the intervention. Adherence was evaluated in the intervention group by self-registration and pedometry, following the CONSORT recommendations for complex interventions.
The information was recorded in an electronic data collection notebook at the beginning of the study, every 15 days during the first 3 months, at the time of healing (if it occurred) and at the end of the 6-month follow-up.
Statistical analysis:
A descriptive analysis (means, medians, and distribution frequencies) was performed. The results of the primary outcomes were analysed on an intention-to-treat (ITT) basis. To analyse the main effectiveness, the incidence rates of ulcers with complete healing were compared and expressed as hazard ratios and 95% confidence intervals. The time to complete healing was compared using Kaplan‒Meier curves (log-rank test). To adjust for prognostic factors, Cox regression was performed. To analyse the secondary results, an explanatory model was adjusted with linear or logistic regression. Significance was set at p < 0.05. All analyses were performed using STATA software, version 18 (43).
RESULTS
Forty-four participants were included, with 22 in each group.
Baseline characteristics were similar between the groups. The mean age was 72.8 years (13.6) in the intervention group and 71.2 years (15.1) in the control group. The sex distributions was similar between groups. The majority of participants were retirees or housewives, with a predominance of individuals with low educational levels. Hypertension was the most frequent comorbidity. No statistically significant differences were observed between the groups.
At the beginning of the study, the mean duration of ulcer development was 44.6 days (45) in the intervention group and 56.6 days (42.2) in the control group. In both groups, 81.8% of the participants received multicomponent compression therapy as part of the usual treatment (Table 1).
A
Intervention group (n = 22) | Control group (n = 22) | p | |
|---|---|---|---|
Sociodemographic variables | |||
Sex (male) | 10 (43.5%) | 13 (56.5%) | 0.56 |
Age (years) | 72.8 (13.6) | 71.2 (15.1) | 0.71 |
Level of education | 0.15 | ||
High | 3 (13.6%) | 0 | |
Medium | 3 (13.6%) | 8 (36.4%) | |
Low | 14 (63.6%) | 13 (59.1%) | |
No education | 2 (9.1%) | 1 (4.5%) | |
Occupation | 0.91 | ||
Retired | 10 (45.5%) | 9 (40.9%) | |
Housewives | 6 (27.3%) | 6 (27.3%) | |
Live alone | 4 (18.2%) | 8 (36.4%) | 0.31 |
Habits and clinical variables | |||
Alcohol consumption | 4 (18.2%) | 6 (27.3%) | 0.72 |
Tobacco use | 4 (18.2%) | 4 (18.2%) | 1 |
Independent ambulation | 18 (81.8%) | 17 (77.3%) | 0.50 |
VREM | 0.30 | ||
Sedentary | 3 (13.6%) | 6 (27.3%) | |
Moderately active | 6 (27.3%) | 5 (22.7%) | |
Assets | 4 (18.2%) | 7 (31.8%) | |
Very Active | 9 (40.9%) | 4 (18.2%) | |
Mean BMI | 30.17 (6.55) | 32.53 (8.77) | 0.32 |
Associated pathologies | |||
Hypertension | 15 (68.2%) | 16 (72.7%) | 1 |
Varicose veins | 13 (59.1%) | 11 (50%) | 0.76 |
Osteoarthritis | 6 (27.3%) | 1 (4.5%) | 0.09 |
Renal insufficiency | 2 (9.1%) | 3 (13.6%) | 1 |
Heart failure | 1 (4.5%) | 5 (22.7%) | 0.2 |
Diabetes mellitus | 1 (4.5%) | 4 (18.2%) | 0.34 |
DVT background | 4 (18.2%) | 0 | 0.1 |
COPD | 1 (4.5%) | 0 | 1 |
Peripheral arterial vascular disease | 1 (4.5%) | 1 (4.5%) | 1 |
Ulcer-related variables | |||
Recurrent ulcer | 8 (36.4%) | 9 (40.9%) | 1 |
Ulcer onset | 0.76 | ||
Traumatic | 10 (43.5%) | 8 (36.4%) | |
Spontaneous | 12 (54.5%) | 14 (63.6%) | |
Number of ulcers | 2 (1.6) | 1.18 (0.4) | 0.17 |
Average time (days) | 44.55 (45) | 56.64 (42.2) | 0.36 |
Resvech score 2.0 | 10.5 (3.2) | 11.23 (3.1) | 0.45 |
Multilayer compression therapy | 18 (81.8%) | 18 (81.8%) | 1 |
Pain | 0.7 | ||
No pain | 2 (9.1%) | 3 (13.6%) | |
Mild | 7 (31.8%) | 9 (40.9%) | |
Moderate | 12 (54.5%) | 8 (36.4%) | |
Intense | 1 (4.5%) | 2 (9.1%) | |
Data are presented as n (%) or mean (SD) | |||
According to the Resvech 2.0 scale, at the baseline assessment, most of the ulcers were smaller than 4 cm2 (63.6% in the intervention group and 72.7% in the control group). The predominant involvement was in the dermis and epidermis (77.8% and 86.4%, respectively).
One hundred percent of the participants in the intervention group and 95.5% of those in the control group had necrotic and/or slough tissue in the wound bed.
A total of 45.5% of the ulcers in the intervention group and 54.5% in the control group were stagnant.
No significant differences were observed between the groups in any of the variables evaluated (Table 2).
Intervention group (n = 22) | Control group (n = 22) | p | |
|---|---|---|---|
Lesion dimensions 0.79 | |||
< 4 cm2 | 14 (63.6%) | 16 (72.7%) | |
4–15 cm2 | 7 (31.8%) | 5 (22.7%) | |
16–35 cm2 | 1 (4.5%) | 1 (4.5%) | |
36–63 cm2 | 0 | 0 | |
64–100 cm2 | 0 | 0 | |
> 100 cm2 | 0 | 0 | |
Depth/Tissues affected 0.35 | |||
Dermis-epidermis | 17 (77.8%) | 19 (86.4%) | |
Subcutaneous tissue | 5 (22.7%) | 3 (13.6%) | |
Thigh | 0 | 0 | |
Edges 0.5 | |||
Not distinguishable | 0 | 1 (4.5%) | |
Diffuse | 6 (27.8%) | 3 (13.6%) | |
Delimited | 13 (59.1%) | 16 (72.7%) | |
Damaged | 2 (9.1%) | 2 (9.1%) | |
Thickened | 1 (4.5%) | 0 | |
Type of tissue in the bed 0.5 | |||
Necrotic | 0 | 0 | |
Necrotic and/or slough | 22 (100%) | 21 (95.5%) | |
Granulation | 0 | 1 (4.5%) | |
Epithelial | 0 | 0 | |
Exudate 0.86 | |||
Dry | 0 | 0 | |
Humid | 15 (68.2%) | 14 (63.6%) | |
Wet | 6 (27.8%) | 3 (13.6%) | |
Saturated | 1 (4.5%) | 1 (4.5%) | |
With exudate leakage | 0 | 4 (18.2%) | |
Infection/inflammation | |||
Increasing pain | 8 (36.4%) | 4 (18.2%) | 0.15 |
Erythema in the perilesion | 13 (59.1%) | 13 (59.1%) | 0.62 |
Oedema in the perilesion | 9 (41%) | 9 (41%) | 0.62 |
Temperature increase | 2 (9.1%) | 3 (13.6%) | 0.5 |
Increasing exudate | 4 (18.2%) | 4 (18.2%) | 0.65 |
Purulent exudate | 1 (4.5%) | 0 | 0.5 |
Friable fabric | 5 (22.7%) | 5 (22.7%) | 0.64 |
Stagnant wound | 10 (45.5%) | 12 (54.5%) | 0.38 |
Biofilm compatible fabric | 8 (36.4%) | 7 (31.8%) | 0.5 |
Odour | 0 | 2 (9.1%) | 0.24 |
Hypergranulation | 1 (4.5%) | 2 (9.1%) | 0.5 |
Increased wound size | 2 (9.1%) | 4 (18.2%) | 0.33 |
Satellite injuries | 6 (27.8%) | 10 (45.5%) | 0.17 |
Paleness of the tissue | 2 (9.1%) | 2 (9.1%) | 0.69 |
Data are presented as n (%). | |||
At 3 months of follow-up, 72.7% [95% CI (57–84)] of the participants achieved complete VU healing, i.e., 77.3% [95% CI (54–91)] in the intervention group and 68.2% [95% CI (45–85)] in the control group, HR = 1.20 [95% CI (0.59–2.42)] (p = 0.61) (Fig. 2) [Figure 2. Kaplan‒Meier curves for the 3-month follow-up data].
Fig. 2
Kaplan‒Meier curves for the 3-month follow-up data
The median time to healing was 45 days [95% CI (37–52)] in the total sample. In the intervention group, the median duration was 35 days [95% CI (29–40)], with no significant differences between the groups (log rank p = 0.585).
At 6 months, 84.1% [95% CI (69–92)] of the participants had complete healing, i.e., 86.4% [95% CI (64–96)] in the intervention group and 81.8% [95% CI (59–94)] in the control group, HR = 1.14 [95% CI (0.59–2.19)] (p = 0.68) (Fig. 3) [Figure 3. Kaplan‒Meier curves for the 6-month follow-up data].
Fig. 3
Kaplan‒Meier curves for the 6-month follow-up data.
The median time to complete healing at 6 months was unchanged from the analysis at 3 months, with no significant differences between groups (log rank p = 0.670).
A Cox regression model was used to estimate the relationships of number of previous days of ulcer evolution, body mass index and baseline exercise, as measured using the VREM, with complete healing. No significant relationship was found with complete healing either at 3 months (Table 3) or at 6 months (Table 4).
HR | 95% CI for HR Lower Upper | p | ||
|---|---|---|---|---|
Group | 1.192 | 0.532 | 2.670 | 0.669 |
Sedentary | 0.886 | |||
Moderately active | 0.685 | 0.205 | 2.284 | 0.380 |
Active | 0.928 | 0.343 | 2.516 | 0.884 |
Very active | 1.037 | 0.369 | 2.913 | 0.944 |
Previous days of ulcer evolution | 0.994 | 0.985 | 1.003 | 0.207 |
BMI | 1.011 | 0.966 | 1.058 | 0.642 |
HR | 95% CI for HR Lower Upper | p | ||
|---|---|---|---|---|
Group | 1.141 | 0.535 | 2.431 | 0.733 |
Sedentary | 0.848 | |||
Moderately active | 0.698 | 0.234 | 2.083 | 0.519 |
Active | 0.688 | 0.259 | 1.832 | 0.454 |
Very active | 0.899 | 0.340 | 2.382 | 0.831 |
Previous days of ulcer evolution | 0.995 | 0.987 | 1.003 | 0.212 |
BMI | 1.007 | 0.966 | 1.051 | 0.731 |
At three months, the degree of healing, as measured with the Resvech 2.0 scale, was reduced by an average of 4.37 points [95% CI (2,284-6,468)], and at 6 months, it was reduced by 6.41 points [95% CI (3,486-9,326)]. When the total sample was considered, all the changes from baseline were statistically significant, but there were no differences between the groups.
In the intervention group, the level of adherence to LL home exercises was high at the first visit. At the first follow-up visit, 54.5% of the participants reported excellent adherence (performance of more than 75% of the prescribed home exercises), 27.3% reported good adherence (50–74%), and 18.2% reported moderate adherence (25–49%).
This pattern was maintained at the second visit, but from the third visit, a progressive decrease was observed, with excellent adherence decreasing to 22.7% and stabilizing between 9% and 13% at subsequent visits (Fig. 4) [Figure 4. Percentage of participants by visit and level of compliance with home exercises].
Fig. 4
Percentage of participants by visit and level of compliance with home exercises
Table 5 presents the median and interquartile range of the daily step count in the intervention group during each follow-up visit. The median ranged between approximately 2,500 and 3,500 daily steps.
Median | Interquartile range (IR) | ||
|---|---|---|---|
Visit 1 (15 days) | 2781.5 | 5810 | |
Visit 2 (1 month) | 3246 | 3559 | |
Visit 3 (1 month and 15 days) | 2017 | 3606 | |
Visit 4 (2 months) | 3523 | 4967 | |
Visit 5 (2 months and 15 days) | 3762 | 5743 | |
Visit 6 (3 months) | 3859.5 | 6939 | |
Visit 7 (6 months) | 3335.5 | 4597 | |
Overall adherence to the intervention, defined as performing more than 75% of the home exercises and a daily average of more than 3000 steps, was generally low; in the first two visits, the estimated percentages of participants with global adherence were 20% and 46%, respectively.
After the third visit, a marked decrease was observed, stabilizing at levels below 15% for subsequent visits (Fig. 5) [Figure 5. Estimation of the mean percentage of participants with global adherence to treatment until healing].
Fig. 5
Estimation of the mean percentage of participants with global adherence to treatment until healing
When comparing the people in the intervention group who met the global adherence criteria of the intervention with those in the control group, no significant differences were observed in effectiveness at 3 months of follow-up, according to the log rank test results (p = 0.64).
DISCUSSION
This study evaluated the effectiveness of a structured programme involving home physical exercise and daily walking, i.e. "Active Legs," as an adjunctive treatment for the healing of VUs in primary care. Although a greater proportion of complete healing was observed in the intervention group both at 3 months (77.3% vs. 68.2%) and at 6 months (86.4% vs. 81.8%), the differences did not reach statistical significance. These results are consistent with the findings of other clinical trials that, despite showing favourable trends, failed to show significant differences (19–21, 31).
However, some studies with larger sample sizes or longer durations of follow-up reported significant differences. For example, Heinen (18) reported significantly shorter healing times after 18 months of follow-up with an intervention based on walking and LL exercises; O'Brien (3) also reported significant differences in healing rates at 3 months, but only in participants with high adherence to the exercise program.
Although no differences were observed in healing, other studies have reported benefits of physical exercise on the function of muscle pumps in the leg, such as an increase in the ejection fraction and a reduction in the residual fraction (27, 29). These findings suggest that exercise may have beneficial physiological effects even if it does not directly translate into a higher rate of healing in the short term.
Limitations and strengths
One of the main limitations of this study was that it did not reach the expected sample size (n = 224), which reduced the statistical power to detect significant differences. Recruitment was affected by external factors such as the COVID-19 pandemic, the consequent reorganization of primary care and the labour mobility of professionals to achieve health care objectives, which relegated research activity to the background.
Another relevant limitation was the low overall adherence to the intervention, especially with regard to daily ambulation. Although more than 50% of the participants in the intervention group reported performing > 75% of the home exercises at the first visit, only between 20% and 46% reached the goal of daily steps (> 3000), and this proportion decreased dramatically after 6 weeks. This pattern is similar to that observed in previous studies, such as studies by Heinen and Meagher (18, 25) in which adherence to exercise was greater than that to walking.
In terms of strengths, there were no dropouts during follow-up, which reinforces the viability of the programme in primary care. In addition, standardized and validated tools such as the RESVECH 2.0 scale and ABI measurements were used to ensure sample homogeneity. The follow-up was intensive and was carried out both in person and by telephone, which allowed more robust data collection.
CONCLUSIONS
The "Active Legs" programme showed a positive trend in promoting the healing of VUs in primary care at 3 and 6 months of follow-up, although we did not find statistically significant differences, probably because the sample size was smaller than expected, which limits the possibility of drawing conclusions about the effectiveness of the intervention.
The level of global adherence to the intervention was lower than expected, with greater participation within the first two visits and a greater degree of compliance in home physical exercise programmes than in daily walking.
Despite the limitations of the study, the results suggest that physical exercise can be an effective complement in the treatment of VUs, especially if adherence to the programme is ensured. The need for studies with larger samples, unified exercise programs and long-term follow-up, as well as the importance of professional training to promote adherence to and personalization of treatment, is highlighted.
LIST OF ABBREVIATIONS
VU
Venous ulcer
LL
Lower limb
ABI
Ankle-brachial index
CRDe
Electronic data collection notebook
ISCIII
Carlos III Health Institute
Declarations
Ethics approval and consent to participate:
A
All of the participants (patients and nurses) provided written informed consent.A
A
This study was conducted respecting the basic ethical principles of autonomy, beneficence, justice and nonmaleficence, in accordance with the standards of Good Clinical Practice, the Declaration of Helsinki (Helsinki 2024) and the Oviedo Convention (1997). The processing, communication and transfer of data were carried out in accordance with the provisions of current regulations.A
The study was approved by the Clinical Research Ethics Committee of the Clinical Hospital San Carlos (03/16/2018) and the Central Research Commission of the Madrid Primary Health Care Management Department (05/16/2018).Consent for publication:
Not applicable.
A
Data Availability
There are ethical and legal restrictions on sharing the dataset generated by the study because it contains sensitive clinical information about the people participating in the trial. The Ethics Committee approved this research without considering the option of sharing the data. Therefore, these data will not be publicly available. The Active Legs group may establish future collaborations with other groups based on these data, in which case the principal investigator [BJHA] should be contacted. Each new project based on these data must first be submitted to the Ethics Committee for approval.
Competing interests:
All the authors declare that they have no competing interests.
A
Funding:
This study is funded by the Carlos III Health Institute (ISCIII) through the PI19/00619 project and co-financed by the European Union.
The translation and financing of the publication have been carried out thanks to funds from the Foundation for Biosanitary Research and Innovation in Primary Care (FIIBAP).
A
A
Author Contribution
Regarding trial management, BJHA (principal investigator), MCFA (coprincipal investigator), PMV, JVS and MRB conceived the study and participated in its design and coordination. Clinical investigators at primary health care centres (“Active Legs” group) collected the data for the study, which included recruiting patients. Statistical analyses were performed by BJHA, RRB, MRB, RSR and MPG. The writing committee comprised BJHA, CFA, MRB, RSR and MPG. All of the authors in the “Active Legs” group read and approved the final manuscript. The corresponding author had full access to the data for the study and has final responsibility for the decision to submit the manuscript for publication.Active legs group members: Abrantes Healthcare center: Araceli Rivera-Álvarez. Dr Mendiguchía Carriche Healthcare center: Alberto López-García-Franco, Belén Pose-García, Juan Carlos García-Álvarez, Julia de-las-Pozas-Abril, Rocío López-Sánchez, Rocío Muñoz-Caballero. Jaime Vera Healthcare center: Mónica Rodríguez-Vegue. La Paz Healthcare center: Layla El-Jundi-Carrasco. Martín de Vargas Healthcare center: Esther González-Prado. Numancia Healthcare center: Beatriz Valdivielso-Fernandez-de-Valderrama, Remedios Laguna-Prados. Pacífico Healthcare center: Belén Peláez-Raposo. Paracuellos del Jarama Healthcare center: María Jesús Calvo-Martínez, Pilar Lebracón-Cortés. Paseo Imperial Healthcare center: Virginia Prado-Fidalgo. Pavones Healthcare center: David Villamañan-Lobo. Villa de Vallecas Healthcare center: Beatriz Navarro-Mallen, Jose David Arroyo-Romero. El Molar Healthcare center: Marta Berrocal-García. Colmenar de Oreja Healthcare center: María José Hita-Urias.
Acknowledgements:
We would like to acknowledge the methodological support from the Research Unit of the Primary Care Assistance Management of Madrid and the health care directors and nurses that make up the clinical care group and are immersed in the recruitment of subjects and study field work.
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Members of the active legs group.
Araceli Rivera-Álvarez. Abrantes Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Alberto López-García-Franco. Dr Mendiguchía Carriche Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Belén Pose-García. Dr Mendiguchía Carriche Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Juan Carlos García-Álvarez. Dr Mendiguchía Carriche Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Julia de-las-Pozas-Abril. Dr Mendiguchía Carriche Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Rocío López-Sánchez. Dr Mendiguchía Carriche Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Rocío Muñoz-Caballero. Dr Mendiguchía Carriche Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Mónica Rodríguez-Vegue. Jaime Vera Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Layla El-Jundi-Carrasco. La Paz Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Esther González-Prado. Martín de Vargas Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Beatriz Valdivielso-Fernandez-de-Valderrama. Numancia Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Remedios Laguna-Prados. Numancia Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Belén Peláez-Raposo. Pacífico Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
María Jesús Calvo-Martínez. Paracuellos del Jarama Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Pilar Lebracón-Cortés. Paracuellos del Jarama Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Virginia Prado-Fidalgo. Paseo Imperial Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
David Villamañan-Lobo. Pavones Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Beatriz Navarro-Mallen. Villa de Vallecas Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Jose David Arroyo-Romero. Villa de Vallecas Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
Marta Berrocal-García. El Molar Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.
María José Hita-Urias. Colmenar de Oreja Healthcare center. Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.