The Effect of Structured Exercise on Chronic Venous Insufficiency
NCT ID: NCT03562546
Last Updated: 2018-06-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-01
Study Completion Date
2019-02-28
Brief Summary
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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
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
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Detailed Description
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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.
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.
Conditions
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Chronic Venous Insufficiency
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Strength From Within
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Galway Clinic
NETWORK
Sponsor Role
collaborator
Shannon Hernon
OTHER
Sponsor Role
lead
Responsible Party
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Shannon Hernon
PhD Researcher
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Micheál Newell, PhD
Role: PRINCIPAL_INVESTIGATOR
National University of Ireland, Galway, Ireland
Locations
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Galway Clinic
Galway, , Ireland
Site Status
RECRUITING
Countries
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Ireland
Central Contacts
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Facility Contacts
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Micheál Newell, PhD
Role: backup
References
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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.
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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.
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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369921
Identifier Type: -
Identifier Source: org_study_id
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