The Effect of Structured Exercise on Chronic Venous Insufficiency

Chronic Venous Insufficiency Clinical Trial

— CVI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03562546
• Other study ID #: 369921
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: June 2018
• Source: National University of Ireland, Galway, Ireland
• Contact: Shannon M Hernon, PhDStudent
• Phone: +353867761346
• Email: shernon10[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Ireland	Galway Clinic	Galway

Sponsors (2)

Lead Sponsor	Collaborator
Shannon Hernon	Galway Clinic

Country where clinical trial is conducted

Ireland, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calf Muscle Pump Function	Duplex Ultrasound Scanning-to determine the nature and extent of venous reflux	12 Weeks
Primary	Calf Muscle Strength	Isokinetic Testing- Biodex	12 Weeks
Primary	Venous Clinical Severity Score	Questionnaire assessing severity of the patients' chronic venous insufficiency and to monitor any progression made	12 Weeks
Secondary	Ankle Joint Range of Motion	Goniometer	12 Weeks
Secondary	Overall physical strength	Muscle Strength Endurance Testing	12 Weeks
Secondary	Quality of life	SF-36 Short Form Health Survey	12 Weeks