Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency.

NCT06727968 | Completed

• 1 other identifier: CVI_Fuensanta
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether the inclusion of a physiotherapy approach in primary care consultation prescribing exercises and teaching self-massage techniques would be well accepted by patients of chronic venous insufficiency and provide higher benefits in the self-management.

Conditions

Chronic Venous Insufficiency, CVI

Keywords

Therapeutic exercise; Massage; Compression Stocking; Physiotherapy

Outcome Measures

Primary Outcomes (5)

• Edema

  Was measured through the right and left leg circumference measurement. Four points were marked in both patients' legs (12 cm from the Hallux extreme direction to the heel, 10, 20 and 30 cm from the heel direction to knee) and total volume was calculated using the formula of the sum of all partial volumes squared divided by pi.

  Pre-intervention and after 16 weeks of intervention

• Functionality in gait

  Was assessed using the 6-Minutes Walking Test (6MWT) that evaluates the maximum distance that the patient is able to walk in 6 minutes. To perform the test, a corridor of 30 meters with a wide enough for patients who need walking aids and at least 30 meters long is required. The place where the 30-meter distance begins and ends will be marked on the floor. Two cones will also be placed, which the patient will walk around.

  Pre-intervention and after 16 weeks of intervention

• Physical Activity Level

  Was measured using the International Physical Activity Questionnaire (IPAQ) that is an indirect outcome measure that seeks information on the frequency and duration of walking and daily activities that require moderate to vigorous physical effort, as well as time spent sitting during the week and at the weekend.

  Pre-intervention and after 16 weeks of intervention

• Prevention measures employed

  The prevention measures employed were quantified in a check list of 10 items that included: (1) Use of tight clothing; (2) Use of high-heeled shoes; (3) Lubrication of legs and ankles with self-massage; (4) Avoid direct heat sources on the legs; (5) Hydromassage with cold water; (6) Use of compression stockings; (7) Prevention of chronic constipation; (8) Continued trauma to legs and feet; (9) Elevate legs during the day or night; (10) Avoid long periods of sitting or standing. A total score of 0 implies that none of the venous hygiene measures was carried out, and a score of 10 implies that all of them are fulfilled.

  Pre-intervention and after 16 weeks of intervention

• Functionality of lower limbs

  The 5 Times Sit to Stand Test (5TSTST) assesses about the functional strength of lower limbs, transitional movements, balance and risk of falling. The test is based on the amount of time it takes a patient to go from a sitting to a standing position 5 times with the arms crossed over the chest. The equipment needed to perform the test is a stopwatch and a chair of standard height.

  Pre-intervention and after 16 weeks of intervention

Secondary Outcomes (3)

• CVI symptoms and severity

  Baseline

• Satisfaction with the treatment

  After 16 weeks of intervention

• Adherence to treatment

  After 16 weeks of intervention

Other Outcomes (4)

• Demographic information

  Baseline

• Clinical measures

  Baseline

• Comorbidies

  Baseline

Study Arms (2)

Conventional approach or control group

EXPERIMENTAL

This group were provided with a pamphlet with general preventive recommendations and, in addition, their primary care physicians prescribed to the participants a gradual compression stocking, that exerted maximum pressure on the ankle that progressively decreases towards the proximal part of the extremity and their were instructed to wear it at least 6-8 hours at day.

Procedure: Compression Stocking; Procedure: Prevention measures

Multimodal approach or experimental group

EXPERIMENTAL

To the intervention carried out in the control group a home-based program of therapeutic exercise and self-massage presecribed by a physiotherapis was added. Home-based therapeutic exercises were based on calf strengthening, mobility and stretching of lower limbs performed in standing, sitting and laying position. Each exercise was performed 15-20 repetitions, 1 set, 3-4 days at week. In addition to these exercises, patients were instructed to walk, at least, 20 minutes at day. Self-massage techniques alterne manual lymphatic drainage maneuvers with superficial techniques that follow the path of saphenous veins, their respective cayaids and the anastomotic system.

Procedure: Compression Stocking; Procedure: Therapeutic exercise; Procedure: Self-massage; Procedure: Prevention measures

Interventions

Compression Stocking PROCEDURE

Wear the compression stockin at least 6-8 hours/day

Also known as: Compression therapy

Conventional approach or control group; Multimodal approach or experimental group

Therapeutic exercise PROCEDURE

Home-based exercise programm based on calf strengthening, mobility and stretching of lower limbs performed in standing, sitting, and laying position. Each exercise was performed 15-20 repetitions, 1 set, 3-4 days at week. In addition to these exercises, patients were instructed to walk, at least, 20 minutes at day.

Multimodal approach or experimental group

Self-massage PROCEDURE

Self-massage techniques alterne manual lymphatic drainage maneuvers with superficial techniques that follow the path of saphenous veins, their respective cayaids and the anastomotic system.

Multimodal approach or experimental group

Prevention measures PROCEDURE

General preventive recommendations, and they were explained to the patient by the primary care physician. Those recommendations were based on the reduction in risk factors described in the Guide of "Recommendations for the management of Chronic Venous Disease in Primary Care" published by Semergen and semFYC.

Conventional approach or control group; Multimodal approach or experimental group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed of CVI
• aged between 18 and 85 years and
• with mobile or email address to send the study information and follow-up

You may not qualify if:

• Mental or psychological condition that impairs the study development
• comorbidities that impair the physical activity performance
• surgical interventions during the 6 previous months before the intervention or during the study development
• deep vein thrombosis
• active leg ulcer
• pregnancy.

Sponsors & Collaborators

• University of Valencia: lead
• Hospital General Valencia: collaborator

Study Sites (1)

Spain

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Blindness, Cortical

Interventions

Stockings, Compression; Exercise Therapy

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 11, 2024
• Study Start: March 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)