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

NCT ID: NCT06727968

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-08-30

Brief Summary

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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.

Detailed Description

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This study aimed at comparing the effects of conventional therapy approaches based on compression stocking and prevention measures with a combined program of these techniques added to therapeutic exercise and self-massage explained by a physiotherapist on on functionality, general physical activity and oedema of people with CVI. In this sense, a randomized controlled trial two armed group was designed.

Conditions

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Chronic Venous Insufficiency, CVI

Keywords

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Therapeutic exercise Massage Compression Stocking Physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Conventional approach or control group

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.

Group Type EXPERIMENTAL

Compression Stocking

Intervention Type PROCEDURE

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

Prevention measures

Intervention Type 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.

Multimodal approach or experimental group

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.

Group Type EXPERIMENTAL

Compression Stocking

Intervention Type PROCEDURE

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

Therapeutic exercise

Intervention Type 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.

Self-massage

Intervention Type 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.

Prevention measures

Intervention Type 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.

Interventions

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Compression Stocking

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

Intervention Type PROCEDURE

Therapeutic exercise

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.

Intervention Type PROCEDURE

Self-massage

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.

Intervention Type PROCEDURE

Prevention measures

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.

Intervention Type PROCEDURE

Other Intervention Names

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Compression therapy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Mental or psychological condition that impairs the study development
2. comorbidities that impair the physical activity performance
3. surgical interventions during the 6 previous months before the intervention or during the study development
4. deep vein thrombosis
5. active leg ulcer
6. pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Valencia

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Martín-San-Agustin

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Spain

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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CVI_Fuensanta

Identifier Type: -

Identifier Source: org_study_id