NCT03562546: CVI

The Effect of Structured Exercise on Chronic Venous Insufficiency

Status unknown NA Last updated 19 June 2018

What this trial tests

NA trial testing Strength From Within in Chronic Venous Insufficiency in 60 participants. Status unknown.

Timeline

1 August 2018

Primary endpoint
30 November 2018

28 February 2019

Quick facts

Lead sponsor	Shannon Hernon
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 August 2018
Primary completion	30 November 2018
Estimated completion	28 February 2019
Sites	1 location across Ireland

Drugs / interventions tested

• Strength From Within

Conditions studied

• Chronic Venous Insufficiency — all drugs for Chronic Venous Insufficiency →

Sponsor

Shannon Hernon

Who can join

Adults 18 to 99, any sex, with Chronic Venous Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Individuals with Chronic Venous Insufficiency (CVI) face a number of complications, such as, muscular dysfunction, limited ankle range of motion(ROM) and diminished calf muscle pump function. Exercise therapy has been shown to improve calf muscle pump function and symptoms and may provide additional therapeutic benefits. It has been reported that structured exercise has the ability to improve ankle joint range of motion, calf muscle strength and calf muscle pump function.

Participants will receive the 12-week structured resistance exercise programme, 'Strength from Within', a warm up and cool down, walking programme and range of motion exercises. Participants will complete the Short Form quality of life (SF-36) Health Survey and the venous clinical severity score questionnaire.

Baseline testing will be conducted. The following measures will be employed in the study through a baseline testing and repeated at the end of the study period (week 12): Functional ambulatory measurements, physical activity measurements (muscle endurance), isokinetic testing (strength), duplex ultrasound scanning.

A combination of upper and lower body structured exercise as well as, ankle join range of motion and a walking regimen has the potential to have a significant impact on an individual's calf muscle pump function and avoid these potentially harmful side effects of lower body exercise programmes

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Physical exercise for the treatment of non-ulcerated chronic venous insufficiency.
   Araujo DN, Ribeiro CT, Maciel AC, Bruno SS, et al · · 2023 · cited 5× · PMID 37314059 · DOI 10.1002/14651858.cd010637.pub3