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

U

University of Valencia

Status

Completed

Conditions

Chronic Venous Insufficiency, CVI

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06727968
CVI_Fuensanta

Details and patient eligibility

About

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.

Full description

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.

Enrollment

34 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

34 participants in 2 patient groups

Conventional approach or control group
Experimental group
Description:
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.
Treatment:
Procedure: Prevention measures
Procedure: Compression Stocking
Multimodal approach or experimental group
Experimental group
Description:
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.
Treatment:
Procedure: Therapeutic exercise
Procedure: Prevention measures
Procedure: Self-massage
Procedure: Compression Stocking

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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