The Effect of Structured Exercise on Chronic Venous Insufficiency (CVI)

June 17, 2018 updated by: Shannon Hernon

The Effect of Structured Exercise on Chronic Venous Insufficiency: A Feasibility Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There will be a total of sixty participants recruited for the study, with an anticipation of 40 to complete the study. Participants will complete the Physical Activity Readiness Questionnaire (PAR-Q) to ensure that they are able to participate in the structured exercise programme. If the participants' answers "yes" to any question on the Physical Activity Readiness Questionnaire (PAR-Q), he/she is ineligible to participate. Participants will also read a participant information leaflet and sign an informed consent before participating in the study. Baseline demographic will be collected at the start of the study. Participants will complete the SF-36 Health Survey at session one and session 2 (week 12). 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, isokinetic testing, duplex ultrasound screening.

Upon completing baseline testing participants will have the warm-up, cool-down, stretches, all exercise demonstrated and explained to them. Participants will go through each exercise with the principal investigator to ensure understanding. The principal investigator will then describe each section of the "Strength From Within" Booklet. At the end of the first session the participants will be administered their at home structured exercise booklet, recording booklet, resistance band, warm-up and cool-down information sheet and their ankle range of motion information sheet.

The baseline meeting and the week 12 meeting will take roughly 90 minutes to complete all baseline measurements, questionnaires, isokinetic testing and demonstrations. Isokinetic testing will take a total of 32 minutes with resting periods included in the time, baseline measurements including the muscle strength and functional ambulatory measurements will take a duration of 10.5 minutes, demonstration of the home structured exercise programme will take up to 20 minutes, both questionnaires will take 5-minutes total and time left for any other questions or concerns. Extra time will be given at any point during both meetings if needed by the participant.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
      • Galway, Ireland
        • Recruiting
        • Galway Clinic
        • Contact:
        • Contact:
          • Micheál Newell, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured Resistance Exercise
12 week at home structured resistance exercise programme ('Strength From Within') using resistance bands. Under the supervision of an experienced exercise specialist.
Other: Strength From Within
A 12 week at home structured resistance exercise programme using resistance bands. Participants will also receive a walking programme, a warm up and cool down, and ankle range of motion exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calf Muscle Pump Function
Time Frame: 12 Weeks
Duplex Ultrasound Scanning-to determine the nature and extent of venous reflux
12 Weeks
Calf Muscle Strength
Time Frame: 12 Weeks
Isokinetic Testing- Biodex
12 Weeks
Venous Clinical Severity Score
Time Frame: 12 Weeks
Questionnaire assessing severity of the patients' chronic venous insufficiency and to monitor any progression made
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle Joint Range of Motion
Time Frame: 12 Weeks
Goniometer
12 Weeks
Overall physical strength
Time Frame: 12 Weeks
Muscle Strength Endurance Testing
12 Weeks
Quality of life
Time Frame: 12 Weeks
SF-36 Short Form Health Survey
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shannon Hernon

Collaborators

Galway Clinic

Investigators

  • Principal Investigator: Micheál Newell, PhD, National University of Ireland, Galway, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

November 30, 2018

Study Completion (Anticipated)

February 28, 2019

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 17, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 17, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 369921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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