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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562546
Recruitment Status : Unknown
Verified June 2018 by Shannon Hernon, National University of Ireland, Galway, Ireland.
Recruitment status was:  Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Galway Clinic
Information provided by (Responsible Party):
Shannon Hernon, National University of Ireland, Galway, Ireland

Brief 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


Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Other: Strength From Within Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Structured Exercise on Chronic Venous Insufficiency: A Feasibility Trial
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Calf Muscle Pump Function [ Time Frame: 12 Weeks ]
    Duplex Ultrasound Scanning-to determine the nature and extent of venous reflux

  2. Calf Muscle Strength [ Time Frame: 12 Weeks ]
    Isokinetic Testing- Biodex

  3. Venous Clinical Severity Score [ Time Frame: 12 Weeks ]
    Questionnaire assessing severity of the patients' chronic venous insufficiency and to monitor any progression made


Secondary Outcome Measures :
  1. Ankle Joint Range of Motion [ Time Frame: 12 Weeks ]
    Goniometer

  2. Overall physical strength [ Time Frame: 12 Weeks ]
    Muscle Strength Endurance Testing

  3. Quality of life [ Time Frame: 12 Weeks ]
    SF-36 Short Form Health Survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562546


Contacts
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Contact: Shannon M Hernon, PhDStudent +353867761346 shernon10@gmail.com

Locations
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Ireland
Galway Clinic Recruiting
Galway, Ireland
Contact: Shannon M Hernon, PhD Student    0867761346    shernon10@gmail.com   
Contact: Micheál Newell, PhD         
Sponsors and Collaborators
Shannon Hernon
Galway Clinic
Investigators
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Principal Investigator: Micheál Newell, PhD National University of Ireland, Galway, Ireland
  Study Documents (Full-Text)

Documents provided by Shannon Hernon, National University of Ireland, Galway, Ireland:
Publications:
O'Donovan K, Bajd T, Grace P, O'Keeffe D, Lyons G. Preliminary Evaluation of Recommended Airline Exercises for Optimal Calf Muscle Pump Activity. EJVES Extra. 2006;12(1):1-5. doi:10.1016/j.ejvsextra.2006.04.001
Browse N, Burnand K. CAUSE OF VENOUS ULCERATION. The Lancet. 1982;320(8304):932. doi:10.1016/s0140-6736(82)90901-1.
Eklöf, Rutherford, Bergan et al. Revision of the CEAP classification for chronic venous disorders: a consensus statement. Vasa. 2005;34(3):157-161. doi:10.1024/0301-1526.34.3.157.
Boyle M, Galway B, McLaughlin T et al. Evidence-Based Clinical Protocols: 3) Anterior Cruciate Ligament Injury & Reconstruction. New York; 2006:3-3. Available at: http://www.biodex.com/sites/default/files/900521anterior.pdf.
Boyle M, Jacoby S, McLaughlin T et al. Evidence-Based Clinical Protocols 5) Lateral Ankle Sprains. New York; 2006:5-9. Available at: http://www.biodex.com/sites/default/files/900521lateral.pdf.
Get walking with this 12-week walking schedule - Mayo Clinic. Mayo Clinic. 2017. Available at: http://www.mayoclinic.org/healthy-lifestyle/fitness/in-depth/walking/art-20050972.

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Responsible Party: Shannon Hernon, PhD Researcher, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT03562546    
Other Study ID Numbers: 369921
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shannon Hernon, National University of Ireland, Galway, Ireland:
CVI
Calf Muscle Pump Function
Structured Exercise
Varicose Veins
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases