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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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)).
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.
Borja Jesús Herraiz Ahijado
Madrid, Spain
Complete healing at 6 months of follow-up
(yes/no) (complete and sustained epithelialisation for at least 2 weeks).
Time frame: 6 months
Time elapsed between start of the study and complete healing of the wound
(in days)
Time frame: 6 months
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.
Time frame: Measured at the beginning (basal) and fortnightly up to 3 months and at 6 months.
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.
Time frame: 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)
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).
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.
Time frame: 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.
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.
Level of adherence to the intervention "Active Legs". Time.
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.
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%.
Time frame: In the intervention group. Measured biweekly coinciding with follow-up visits up to 3 months and 6 months.
Age (sociodemographic variables)
in years
Time frame: Measured at the beginning (baseline)
Sex (sociodemographic variables)
Male/Female
Time frame: Measured at the beginning (baseline)
Living alone (sociodemographic variables)
Yes/no
Time frame: Measured at the beginning (baseline)
Employment status (sociodemographic variables)
housewife / unemployed / student / worker employee account / worker own account
Time frame: Measured at the beginning (baseline)
Education level (sociodemographic variables)
low / medium / high
Time frame: Measured at the beginning (baseline)
Weight (variables related to the healing process)
in kilograms. weight and height will be combined to report BMI in kg/m\^2
Time frame: Measured at the beginning (baseline)
Height (variables related to the healing process)
in meters. weight and height will be combined to report BMI in kg/m\^2
Time frame: Measured at the beginning (baseline)
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.
Time frame: Measured at the beginning (baseline)
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).
Time frame: Measured at the beginning (baseline)
Tobacco consumption (variables related to the healing process)
no smoker / smoker / ex-smoker
Time frame: Measured at the beginning (baseline)
Alcohol consumption (variables related to the healing process)
volume grams of alcohol / week
Time frame: Measured at the beginning (baseline)
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.
Time frame: Measured at the beginning (baseline)
Adherence to multilayer compression therapy (variables related to the healing process)
(yes/no)
Time frame: Measured at the beginning (basal) and fortnightly until 3 months and at 6 months .
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 .
Time frame: Measured at the beginning (baseline), in the middle (3 months) and at the end of the study (6 months).
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
Time frame: Measured at the beginning (baseline)
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
Time frame: Measured at the beginning (baseline)
Number of ulcers at the time of the study (prognostic variables)
in number
Time frame: Measured at the beginning (baseline)
Time in days of evolution of the venous ulcers before inclusion in the study (prognostic variables)
in days
Time frame: Measured at the beginning (baseline)
Recurrent ulcer (prognostic variables)
(yes/no)
Time frame: Measured at the beginning (baseline)
Recurrence (variables related to recurrences)
(yes / no)
Time frame: measured at 6 months of follow-up
Use of compression stockings (variables related to recurrences)
(Yes/no) for Light / normal / strong compression
Time frame: measured at 6 months of follow-up
Hydration of the legs (variables related to recurrences)
(Yes/no)
Time frame: measured at 6 months of follow-up
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