Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care.

NCT04039789 | Completed

• 1 other identifier: CCI 11/18
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To evaluate the effectiveness of a structured educational intervention in physical exercise "Active Legs" as an adjuvant treatment to improve the healing of chronic venous ulcers at 3 months of follow-up, compared with the usual practice in people treated in primary care. Secondary objectives: To evaluate if the intervention active legs as an adjuvant treatment produces better results than usual practice in: degree of healing, recurrence, complete healing at 6 months, pain and quality of life. Describe degree of adherence and satisfaction with the intervention. Design: Randomized, multicenter, pragmatic, open clinical trial of parallel groups with 6 months of follow-up. Setting: Primary Care Health Centers (Madrid). Subjects: Patients with venous ulcers, with treatment in the nursing consultation of the participating centers. Sample: 224 participants (112 in each group). Intervention: Both groups will receive the usual treatment of cleaning, debridement based on humid environment cure and multilayer compression therapy according to the recommendations of Community of Madrid. The intervention group will also receive the structured educational intervention of lower limbs physical exercise and daily walking patterns. Variables: Main: complete healing at 3 months follow-up. Secondary: Degree of healing; ulcer area; quality of life; pain, related to the healing process, prognosis and recurrences; Sociodemographic and related adherence and satisfaction. Data analysis: Main effectiveness: comparison of the incidence of ulcers with complete healing at 3 months of follow-up in both groups, time to complete healing (Kaplan-Meier and Log-rank test). Adjustment of prognostic factors (Cox regression).

Conditions

Varicose Ulcer

Keywords

Varicose ulcer; Exercise; Nurses; Healthy Aging

Outcome Measures

Primary Outcomes (2)

• Complete healing at 6 months of follow-up

  (yes/no) (complete and sustained epithelialisation for at least 2 weeks).

  6 months

• Time elapsed between start of the study and complete healing of the wound

  (in days)

  6 months

Secondary Outcomes (29)

• Degree of healing (Resvech 2.0)

  Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.

• Ulceral area

  Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.

• Health-related quality of life for patients with venous ulcers (CCVUQ-e)

  Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).

• Perceived pain: visual analogical scale of the McGill questionnaire

  Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).

• Level of adherence to the intervention "Active Legs". Number of steps.

  In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.

Study Arms (2)

Control

ACTIVE COMPARATOR

Usual Care: that consists of healing the wound (assessment, cleaning, disinfection, debridement and topical treatment) and compression therapy multilayer usual practice, according to the recommendations for the treatment of cutaneous ulcers of the Region of Madrid.

Procedure: Usual care

Intervention

EXPERIMENTAL

ACTIVE LEGS: The usual care plus experimental intervention. It is a structured educational intervention, directed by nurses and carried out in the health center consultations. The intervention "Active Legs" has been designed based on the available evidence. It incorporates a program of lower limb exercise at home and daily walking patterns. Home program of lower limb exercises. The nurse will instruct the patients in the performance of 4 exercises of lower limbs of progressive difficulty that must be performed at home 5 days a week, twice a day Daily walking program. In addition, patients must ambulate progressively until reaching the marked goal (150 min / week (30 minutes for 5 days a week)) . At the start of the study, the "Active Legs" diary will be provided, showing the patterns of the exercise and walking program graphically and a pedometer.

Behavioral: Project active legs; Procedure: Usual care

Interventions

Project active legs BEHAVIORAL

Home program of exercises of lower extremities includes the performance of 4 exercises of lower extremities of progressive difficulty that must be carried out at home 5 days a week, twice a day and walking progressively until reaching the marked goal (150 min / week (30 minutes for 5 days a week)).

Intervention

Usual care PROCEDURE

Evaluation, cleaning, debridement, topical treatment (moist healing) and compressive therapy according to the recommendations for the treatment of chronic cutaneous ulcers of the Community of Madrid.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with a diagnosis of venous ulcers registered in electronic clinical history (history of chronic venous insufficiency and/or venous ulcer) and presence of an ankle brachial index (ABI) greater than 0.8 and less than 1.3.
• Presence at least a venous ulcer of 1cm or more in diameter. If the participant has more than one lesion, the nurse will select the lesion with the highest Resvech 2.0 score for the study.
• Independent ambulation or with the help of devices.
• Individuals who able to follow the demands of the trial and who provide their written informed consent to participate.

You may not qualify if:

• Patients with mixed ulcers.
• Acute phase deep vein thrombosis.
• Patients on treatment with antineoplastic agents.
• Decompensated heart failure.
• Rheumatoid arthritis.
• Acute phase dermatitis, at the time of the study.
• Patients immobilized at home, institutionalized or displaced residing outside the area where the research is conducted for more than 6 months a year or during the performance of the intervention.
• Absolute contraindication to perform physical exercise.
• Patients who are simultaneously participating in another clinical trial.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead

Study Sites (1)

Borja Jesús Herraiz Ahijado

Madrid, Spain

Location

Related Publications (2)

• Herraiz-Ahijado B, Folguera-Alvarez C, Rodriguez-Barrientos R, Sanchez-Ruano R, Pascual-Garcia M, Mori-Vara P, Verdu-Soriano J, Rico-Blazquez M; Active Legs Group. Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: active legs RCT. BMC Nurs. 2025 Dec 10. doi: 10.1186/s12912-025-04189-0. Online ahead of print.

  PMID: 41372918 DERIVED

• Herraiz-Ahijado B, Folguera-Alvarez C, Verdu-Soriano J, Mori-Vara P, Rico-Blazquez M. Active legs: Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: a RCT protocol study. BMC Nurs. 2023 Mar 10;22(1):65. doi: 10.1186/s12912-023-01214-y.

  PMID: 36899351 DERIVED

MeSH Terms

Conditions

Varicose Ulcer; Motor Activity

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Borja Jesús Herraiz Ahijado, Nurse

  Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Intervention can't be masked. We will objectify primary outcome by photography images and adherence to exercise through the use of pedometers. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Clinical nurse

Model Details: Randomised, multicentre clinical trial, parallel, pragmatic, with 6 months of follow-up.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 31, 2019
• Study Start: May 17, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 31, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)