Arm Cycling to Improve Fitness in Polio Survivors
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Impact of an Arm Ergometry Training Programme on Cardiovascular Fitness, Energy Cost of Walking and Fatigue in Prior Polio Patients|
- Six Minute Arm Test [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]The Six Minute Arm test is a submaximal cardiovascular fitness test. The American College of Sports Medicine recommend submaximal fitness testing, limited to 6-12 minutes and using either four limb ergometry or an upper limb ergometer in prior polio patients. The 6 Minute Arm Test (Hol et al 2007) is such a submaximal upper limb exercise test, which has been developed and found valid and reliable in spinal cord injury.
- The Physical Activity Scale for Persons with Physical Disabilities [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]The Physical Activity Scale for Persons with Physical Disabilities is a subjectively reported survey of activity levels in people with physical disabilities. Preliminary validation has been completed by Washburn et al (2002).
- Upper Limb Maximal Voluntary Isometric Contraction [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]Upper limb strength will be measured to determine suitability for exercise and to measure any training related changes. Maximal voluntary isometric contraction of the upper limbs will be measured using fixed dynamometry with the Quantitative Muscle Analysis system. Shoulder abduction, adduction, elbow flexion and extension and hand grip will be measured.
- Body Mass Index and Waist to hip Ratio [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]Body composition will be assessed using Body Mass Index and Waist to hip ratio will be used to measure risk due to overweight / obesity.
- Hand Grip Motor Fatigue [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]Hand grip motor fatigue will be measured using Quantitative Muscle Analysis. This will be measured pre and post training to provide an indication of changes in motor fatigue occurring with training.
- Short Form 36 Version 2 (SF-36 v2) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]The SF-36v2 is a tool developed by Ware (www.sf-36.org), which measures health status. It has been used previously in polio survivors (Vasiliadis et al 2002, Gonzales et al 2006)
- Short Form McGill Pain Questionnaire version 2 (SF-MPQ-2) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]Pain will be assessed using the SF-MPQ-2. The SF-MPQ-2 questionnaire is a well-developed tool for quantitative assessment of pain (Dworkin et al 2009).
- Physiological Cost Index [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]The Physiological Cost Index is a measure, which aims to estimate energy cost of walking, using walking speed and change in heart rate from baseline.
- The Fatigue Severity Scale [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]The Fatigue Severity Scale is a commonly used questionnaire used to assess subjective fatigue
|Study Start Date:||July 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Other: Upper Limb Ergometry
Cardiovascular training will be performed using upper limb ergometers at home for 8 weeks. Each subject will receive an individually prescribed programme and will begin exercising for at least ten minutes per day three days per week. If an individual has difficulty exercising for 10 minutes continuously, the 10 minute session may be broken into 2-3 minute bursts of exercise, with one minute rests. Subjects will aim to increase exercise durations to 20 minutes per day five days per week and will exercise at moderate to high intensities.
|No Intervention: Control|
The American College of Sports Medicine (ACSM) recommendations state that stable muscle groups should be utilised for exercise in polio survivors and that patients with severe atrophic polio or with recent weakness should not exercise, while March of Dimes (2001) recommend not exercising muscle groups where new weakness is being experienced. Floor or treadmill walking or lower limb cycling may also aggravate pain in those with lower limb weakness and altered lower limb biomechanics.
Training with an upper limb ergometer is likely to be an appropriate form of exercise in patients with good, stable upper limb strength. One small, but well designed, trial of upper limb ergometry over 16 weeks resulted in a 19% increase in maximal oxygen uptake (VO2max) in 10 postpolio subjects exercising 3 times per week (Kriz et al 1992). ACSM recommend using a Schwinn Air-DyneTM four limb exerciser; however this is an expensive and bulky piece of equipment and is unlikely to be feasible for ongoing use by community dwelling polio survivors.
A small upper limb ergometer may be a cost effective, accessible option for exercise for community dwelling polio survivors. A closely monitored and carefully prescribed cardiovascular fitness programme may enable polio survivors, who have gained control of symptoms of fatigue and pain through changes in lifestyle and activity, to increase fitness and perhaps subsequently reduce energy cost of walking.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271530
|Dublin, Ireland, D 9|
|Principal Investigator:||Deirdre E Murray, BSc||Royal College of Surgeons in Ireland|
|Study Director:||Dara Meldrum, MSc||Royal College of Surgeons in Ireland|
|Study Director:||Frances Horgan, PhD||Royal College of Surgeons in Ireland|
|Study Chair:||Orla Hardiman, MD||Beaumont Hospital|
|Study Director:||Roisin Moloney, BSc||Beaumont Hospital|