UnknownNot Applicable

The Effect of Structured Exercise on Chronic Venous Insufficiency

Ireland60 participantsStarted 2018-08-01

Plain-language summary

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

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients with chronic venous insufficiency and a Comprehensive Classification System for Chronic Venous Disorder (CEAP) Score of 2,3,4. Exclusion Criteria: * Younger than 18 years * Painful Ulceration * Severe Cardiac Condition * Cardiorespiratory Disease * Failure of Physical Activity Readiness form * American College of Sports Medicine (ACSM) Risk Classification: Class C or above * CEAP classification of 5 or 6 * Severe mobility impairment * Severe imbalance * Women who are pregnant * Women who are breastfeeding * Those who lack capacity to consent * Those for whom English is not the first language and have difficulty understanding written and/or spoken English * Diagnosis of diabetes * Diagnosis of peripheral arterial disease * Diagnosis of peripheral neuropathy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Calf Muscle Pump Function

Timeframe: 12 Weeks

Calf Muscle Strength

Timeframe: 12 Weeks

Venous Clinical Severity Score

Timeframe: 12 Weeks

Trial details

NCT IDNCT03562546

SponsorShannon Hernon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-30

Contact for this trial

Shannon M Hernon, PhDStudent

+353867761346 shernon10@gmail.com

View on ClinicalTrials.gov More Chronic Venous Insufficiency trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.