Skip to main content
OpenTrials
Completed

NCT Number: NCT04039789

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Borja Jesús Herraiz Ahijado

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)).

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.

Primary outcomes

  1. Complete healing at 6 months of follow-up

    Time frame: 6 months

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

  2. Time elapsed between start of the study and complete healing of the wound

    Time frame: 6 months

    (in days)

Secondary outcomes

  1. Degree of healing (Resvech 2.0)

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

    The questionnaire consists of 6 dimensions with ascending scoring scales according to the severity of the dimension studied. It is divided into: depth (0 to 4), size (0 to 6), borders (0 to 4), wound bed (0 to 4), exudate (0 to 3) and signs and symptoms of infection (0 to 14). The total score ranges from 0 to 35.

  2. Ulceral area

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

    In cm2. Measured by digital photography. Measurement through digital photography and subsequent treatment of the image using the open source Java image processing program "The ImageJ ecosystem" and its subsequent calculation using the Visitrack device.

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

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

    It is a questionnaire that measures quality of life in patients with venous ulcers. In addition to a global synthetic quality of life score, it has 4 dimensions: Social interaction, Cosmesis (body image), Emotional state and Domestic activities. Both the general score and the dimensions have a score that ranges from 0 to 100, where 0 is the best quality of life and 100 the worst quality of life.

  4. Perceived pain: visual analogical scale of the McGill questionnaire

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

    The visual analogical scale of the McGill questionnaire will be used. A greater than 20mm in the Visual Analog Scale of pain scale will be considered a clinically significant change.

    It goes from "no pain" 0 to "unbearable pain" 10, the patient will mark that point on the line that best reflects the pain he suffers.

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

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

    Daily record using the Yamax PZ270 pedometer (15 days memory)

  6. Level of adherence to the intervention "Active Legs". Time.

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

    The time in minutes / day

  7. Level of adherence to the intervention "Active Legs". The self-reported information by the patient of the domiciliary exercise program.

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

    By registering in the activity diary, classifying it as "Excellent" in 75% or more of the prescribed sessions, "Good" between 50-74%, "Moderate" between 25-49% and "Poor" less than 25%.

  8. Age (sociodemographic variables)

    Time frame: Measured at the beginning (baseline)

    in years

  9. Sex (sociodemographic variables)

    Time frame: Measured at the beginning (baseline)

    Male/Female

  10. Living alone (sociodemographic variables)

    Time frame: Measured at the beginning (baseline)

    Yes/no

  11. Employment status (sociodemographic variables)

    Time frame: Measured at the beginning (baseline)

    housewife / unemployed / student / worker employee account / worker own account

  12. Education level (sociodemographic variables)

    Time frame: Measured at the beginning (baseline)

    low / medium / high

  13. Weight (variables related to the healing process)

    Time frame: Measured at the beginning (baseline)

    in kilograms. weight and height will be combined to report BMI in kg/m^2

  14. Height (variables related to the healing process)

    Time frame: Measured at the beginning (baseline)

    in meters. weight and height will be combined to report BMI in kg/m^2

  15. Underlying disease (variables related to the healing process)

    Time frame: Measured at the beginning (baseline)

    (yes / no) for heart failure, renal failure, hypertension, diabetes mellitus, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, osteoarthritis, deep vein thrombosis, peripheral arterial vasculopathy, varicose veins.

  16. ABI (variables related to the healing process)

    Time frame: Measured at the beginning (baseline)

    The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).

  17. Tobacco consumption (variables related to the healing process)

    Time frame: Measured at the beginning (baseline)

    no smoker / smoker / ex-smoker

  18. Alcohol consumption (variables related to the healing process)

    Time frame: Measured at the beginning (baseline)

    volume grams of alcohol / week

  19. Topical and systemic treatment (variables related to the healing process)

    Time frame: Measured at the beginning (baseline)

    (yes/no) for hydrocellular dressings, alginates, hydrogels, collagenase, silver dressings, low adhesion dressings, silver sulfadiazine in ointment, other antibiotics in ointment, moisturizing products for the skin.

  20. Adherence to multilayer compression therapy (variables related to the healing process)

    Time frame: Measured at the beginning (basal) and fortnightly until 3 months and at 6 months .

    (yes/no)

  21. Physical activity level measured by the Minnesota free time physical activity questionnaire (variables related to the healing process)

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

    It allows to measure the energy expenditure during free time and allows to classify individuals in activity categories. In metabolic energy turnover (METS)-min/14 days. Interpreting as: very active above 5000 METS-min / 14 days, Active between 3000 and 4999 METS-min / 14 days, Moderately active between 1250 and 2999 METS-min / 14 days and sedentary less than 1250 METS-min / 14 days .

  22. Type of daily walking (variables related to the healing process)

    Time frame: Measured at the beginning (baseline)

    Independent / Independent with technical assistance (cane, crutches or walker with or without wheels) / With the help of the participation of a person without technical assistance / With the help of the participation of a person with technical help

  23. Location of the ulcer (prognostic variables)

    Time frame: Measured at the beginning (baseline)

    internal lateral aspect/ supra-malleolar area/ anterior area of the leg/ external lateral aspect of the leg/ posterior aspect of the leg

  24. Number of ulcers at the time of the study (prognostic variables)

    Time frame: Measured at the beginning (baseline)

    in number

  25. Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)

    Time frame: Measured at the beginning (baseline)

    in days

  26. Recurrent ulcer (prognostic variables)

    Time frame: Measured at the beginning (baseline)

    (yes/no)

  27. Recurrence (variables related to recurrences)

    Time frame: measured at 6 months of follow-up

    (yes / no)

  28. Use of compression stockings (variables related to recurrences)

    Time frame: measured at 6 months of follow-up

    (Yes/no) for Light / normal / strong compression

  29. Hydration of the legs (variables related to recurrences)

    Time frame: measured at 6 months of follow-up

    (Yes/no)

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Registry information

Official study 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

Acronym: ACTIVE_LEGS

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Jul 31, 2019
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.