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

Primary Purpose

Varicose Ulcer

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Project active legs
Usual care
Sponsored by
Gerencia de Atención Primaria, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Ulcer focused on measuring Varicose ulcer, Exercise, Nurses, Healthy Aging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Borja Jesús Herraiz Ahijado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Complete healing at 6 months of follow-up
(yes/no) (complete and sustained epithelialisation for at least 2 weeks).
Time elapsed between start of the study and complete healing of the wound
(in days)

Secondary Outcome Measures

Degree of healing (Resvech 2.0)
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.
Ulceral area
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.
Health-related quality of life for patients with venous ulcers (CCVUQ-e)
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.
Perceived pain: visual analogical scale of the McGill questionnaire
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.
Level of adherence to the intervention "Active Legs". Number of steps.
Daily record using the Yamax PZ270 pedometer (15 days memory)
Level of adherence to the intervention "Active Legs". Time.
The time in minutes / day
Level of adherence to the intervention "Active Legs". The self-reported information by the patient of the domiciliary exercise program.
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%.
Age (sociodemographic variables)
in years
Sex (sociodemographic variables)
Male/Female
Living alone (sociodemographic variables)
Yes/no
Employment status (sociodemographic variables)
housewife / unemployed / student / worker employee account / worker own account
Education level (sociodemographic variables)
low / medium / high
Weight (variables related to the healing process)
in kilograms. weight and height will be combined to report BMI in kg/m^2
Height (variables related to the healing process)
in meters. weight and height will be combined to report BMI in kg/m^2
Underlying disease (variables related to the healing process)
(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.
ABI (variables related to the healing process)
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).
Tobacco consumption (variables related to the healing process)
no smoker / smoker / ex-smoker
Alcohol consumption (variables related to the healing process)
volume grams of alcohol / week
Topical and systemic treatment (variables related to the healing process)
(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.
Adherence to multilayer compression therapy (variables related to the healing process)
(yes/no)
Physical activity level measured by the Minnesota free time physical activity questionnaire (variables related to the healing process)
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 .
Type of daily walking (variables related to the healing process)
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
Location of the ulcer (prognostic variables)
internal lateral aspect/ supra-malleolar area/ anterior area of the leg/ external lateral aspect of the leg/ posterior aspect of the leg
Number of ulcers at the time of the study (prognostic variables)
in number
Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)
in days
Recurrent ulcer (prognostic variables)
(yes/no)
Recurrence (variables related to recurrences)
(yes / no)
Use of compression stockings (variables related to recurrences)
(Yes/no) for Light / normal / strong compression
Hydration of the legs (variables related to recurrences)
(Yes/no)

Full Information

First Posted
July 11, 2019
Last Updated
September 13, 2023
Sponsor
Gerencia de Atención Primaria, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04039789
Brief Title
Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care.
Acronym
ACTIVE_LEGS
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gerencia de Atención Primaria, Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Ulcer
Keywords
Varicose ulcer, Exercise, Nurses, Healthy Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised, multicentre clinical trial, parallel, pragmatic, with 6 months of follow-up.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Project active legs
Intervention Description
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 Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
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 Outcome Measure Information:
Title
Complete healing at 6 months of follow-up
Description
(yes/no) (complete and sustained epithelialisation for at least 2 weeks).
Time Frame
6 months
Title
Time elapsed between start of the study and complete healing of the wound
Description
(in days)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Degree of healing (Resvech 2.0)
Description
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.
Time Frame
Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
Title
Ulceral area
Description
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.
Time Frame
Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
Title
Health-related quality of life for patients with venous ulcers (CCVUQ-e)
Description
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.
Time Frame
Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Title
Perceived pain: visual analogical scale of the McGill questionnaire
Description
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.
Time Frame
Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Title
Level of adherence to the intervention "Active Legs". Number of steps.
Description
Daily record using the Yamax PZ270 pedometer (15 days memory)
Time Frame
In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Title
Level of adherence to the intervention "Active Legs". Time.
Description
The time in minutes / day
Time Frame
In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Title
Level of adherence to the intervention "Active Legs". The self-reported information by the patient of the domiciliary exercise program.
Description
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%.
Time Frame
In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Title
Age (sociodemographic variables)
Description
in years
Time Frame
Measured at the beginning (baseline)
Title
Sex (sociodemographic variables)
Description
Male/Female
Time Frame
Measured at the beginning (baseline)
Title
Living alone (sociodemographic variables)
Description
Yes/no
Time Frame
Measured at the beginning (baseline)
Title
Employment status (sociodemographic variables)
Description
housewife / unemployed / student / worker employee account / worker own account
Time Frame
Measured at the beginning (baseline)
Title
Education level (sociodemographic variables)
Description
low / medium / high
Time Frame
Measured at the beginning (baseline)
Title
Weight (variables related to the healing process)
Description
in kilograms. weight and height will be combined to report BMI in kg/m^2
Time Frame
Measured at the beginning (baseline)
Title
Height (variables related to the healing process)
Description
in meters. weight and height will be combined to report BMI in kg/m^2
Time Frame
Measured at the beginning (baseline)
Title
Underlying disease (variables related to the healing process)
Description
(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.
Time Frame
Measured at the beginning (baseline)
Title
ABI (variables related to the healing process)
Description
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).
Time Frame
Measured at the beginning (baseline)
Title
Tobacco consumption (variables related to the healing process)
Description
no smoker / smoker / ex-smoker
Time Frame
Measured at the beginning (baseline)
Title
Alcohol consumption (variables related to the healing process)
Description
volume grams of alcohol / week
Time Frame
Measured at the beginning (baseline)
Title
Topical and systemic treatment (variables related to the healing process)
Description
(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.
Time Frame
Measured at the beginning (baseline)
Title
Adherence to multilayer compression therapy (variables related to the healing process)
Description
(yes/no)
Time Frame
Measured at the beginning (basal) and fortnightly until 3 months and at 6 months .
Title
Physical activity level measured by the Minnesota free time physical activity questionnaire (variables related to the healing process)
Description
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 .
Time Frame
Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
Title
Type of daily walking (variables related to the healing process)
Description
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
Time Frame
Measured at the beginning (baseline)
Title
Location of the ulcer (prognostic variables)
Description
internal lateral aspect/ supra-malleolar area/ anterior area of the leg/ external lateral aspect of the leg/ posterior aspect of the leg
Time Frame
Measured at the beginning (baseline)
Title
Number of ulcers at the time of the study (prognostic variables)
Description
in number
Time Frame
Measured at the beginning (baseline)
Title
Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)
Description
in days
Time Frame
Measured at the beginning (baseline)
Title
Recurrent ulcer (prognostic variables)
Description
(yes/no)
Time Frame
Measured at the beginning (baseline)
Title
Recurrence (variables related to recurrences)
Description
(yes / no)
Time Frame
measured at 6 months of follow-up
Title
Use of compression stockings (variables related to recurrences)
Description
(Yes/no) for Light / normal / strong compression
Time Frame
measured at 6 months of follow-up
Title
Hydration of the legs (variables related to recurrences)
Description
(Yes/no)
Time Frame
measured at 6 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borja Jesús Herraiz Ahijado, Nurse
Organizational Affiliation
Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borja Jesús Herraiz Ahijado
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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