Chronic Venous Insufficiency Clinical Trial
Official title:
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
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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