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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Varicose Ulcer
- Sponsor
- Gerencia de Atención Primaria, Madrid
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Complete healing at 6 months of follow-up
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Borja Jesús Herraiz Ahijado
Principal Investigator. Clinical nurse
Gerencia de Atención Primaria, Madrid
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.
- •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.
Outcomes
Primary Outcomes
Complete healing at 6 months of follow-up
Time Frame: 6 months
(yes/no) (complete and sustained epithelialisation for at least 2 weeks).
Time elapsed between start of the study and complete healing of the wound
Time Frame: 6 months
(in days)
Secondary Outcomes
- 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.)
- Level of adherence to the intervention "Active Legs". The self-reported information by the patient of the domiciliary exercise program.(In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.)
- Sex (sociodemographic variables)(Measured at the beginning (baseline))
- 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.)
- Level of adherence to the intervention "Active Legs". Time.(In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.)
- Tobacco consumption (variables related to the healing process)(Measured at the beginning (baseline))
- Number of ulcers at the time of the study (prognostic variables)(Measured at the beginning (baseline))
- Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)(Measured at the beginning (baseline))
- 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).)
- Age (sociodemographic variables)(Measured at the beginning (baseline))
- Weight (variables related to the healing process)(Measured at the beginning (baseline))
- Height (variables related to the healing process)(Measured at the beginning (baseline))
- ABI (variables related to the healing process)(Measured at the beginning (baseline))
- Recurrent ulcer (prognostic variables)(Measured at the beginning (baseline))
- Living alone (sociodemographic variables)(Measured at the beginning (baseline))
- Employment status (sociodemographic variables)(Measured at the beginning (baseline))
- Education level (sociodemographic variables)(Measured at the beginning (baseline))
- Alcohol consumption (variables related to the healing process)(Measured at the beginning (baseline))
- Type of daily walking (variables related to the healing process)(Measured at the beginning (baseline))
- Recurrence (variables related to recurrences)(measured at 6 months of follow-up)
- Use of compression stockings (variables related to recurrences)(measured at 6 months of follow-up)
- Hydration of the legs (variables related to recurrences)(measured at 6 months of follow-up)
- Underlying disease (variables related to the healing process)(Measured at the beginning (baseline))
- Adherence to multilayer compression therapy (variables related to the healing process)(Measured at the beginning (basal) and fortnightly until 3 months and at 6 months .)
- Topical and systemic treatment (variables related to the healing process)(Measured at the beginning (baseline))
- Physical activity level measured by the Minnesota free time physical activity questionnaire (variables related to the healing process)(Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).)
- Location of the ulcer (prognostic variables)(Measured at the beginning (baseline))