Clinical trial NCT04039789: Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care.
Official title: Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care: Multicenter Randomized Clinical Trial - Active Legs Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Ulcer
Keywords: Varicose ulcer
Exercise
Nurses
Healthy Aging
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
First posted: 2019-07-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, multicentre clinical trial, parallel, pragmatic, with 6 months of follow-up.
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Complete healing at 6 months of follow-up
timeFrame: 6 months
measure: Time elapsed between start of the study and complete healing of the wound
timeFrame: 6 months
Secondary outcomes:
measure: Degree of healing (Resvech 2.0)
timeFrame: Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
measure: Ulceral area
timeFrame: Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
measure: Health-related quality of life for patients with venous ulcers (CCVUQ-e)
timeFrame: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
measure: Perceived pain: visual analogical scale of the McGill questionnaire
timeFrame: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
measure: Level of adherence to the intervention "Active Legs". Number of steps.
timeFrame: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
measure: Level of adherence to the intervention "Active Legs". Time.
timeFrame: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
measure: Level of adherence to the intervention "Active Legs". The self-reported information by the patient of the domiciliary exercise program.
timeFrame: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
measure: Age (sociodemographic variables)
timeFrame: Measured at the beginning (baseline)
measure: Sex (sociodemographic variables)
timeFrame: Measured at the beginning (baseline)
measure: Living alone (sociodemographic variables)
timeFrame: Measured at the beginning (baseline)
measure: Employment status (sociodemographic variables)
timeFrame: Measured at the beginning (baseline)
measure: Education level (sociodemographic variables)
timeFrame: Measured at the beginning (baseline)
measure: Weight (variables related to the healing process)
timeFrame: Measured at the beginning (baseline)
measure: Height (variables related to the healing process)
timeFrame: Measured at the beginning (baseline)
measure: Underlying disease (variables related to the healing process)
timeFrame: Measured at the beginning (baseline)
measure: ABI (variables related to the healing process)
timeFrame: Measured at the beginning (baseline)
measure: Tobacco consumption (variables related to the healing process)
timeFrame: Measured at the beginning (baseline)
measure: Alcohol consumption (variables related to the healing process)
timeFrame: Measured at the beginning (baseline)
measure: Topical and systemic treatment (variables related to the healing process)
timeFrame: Measured at the beginning (baseline)
measure: Adherence to multilayer compression therapy (variables related to the healing process)
timeFrame: Measured at the beginning (basal) and fortnightly until 3 months and at 6 months .
measure: Physical activity level measured by the Minnesota free time physical activity questionnaire (variables related to the healing process)
timeFrame: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
measure: Type of daily walking (variables related to the healing process)
timeFrame: Measured at the beginning (baseline)
measure: Location of the ulcer (prognostic variables)
timeFrame: Measured at the beginning (baseline)
measure: Number of ulcers at the time of the study (prognostic variables)
timeFrame: Measured at the beginning (baseline)
measure: Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)
timeFrame: Measured at the beginning (baseline)
measure: Recurrent ulcer (prognostic variables)
timeFrame: Measured at the beginning (baseline)
measure: Recurrence (variables related to recurrences)
timeFrame: measured at 6 months of follow-up
measure: Use of compression stockings (variables related to recurrences)
timeFrame: measured at 6 months of follow-up
measure: Hydration of the legs (variables related to recurrences)
timeFrame: measured at 6 months of follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Borja Jesús Herraiz Ahijado
Study officials:
affiliation: Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
name: Borja Jesús Herraiz Ahijado, Nurse
role: PRINCIPAL_INVESTIGATOR
References: