Arm Cycling to Improve Fitness in Polio Survivors

Postpoliomyelitis Syndrome Clinical Trial

Official title:

The Impact of an Arm Ergometry Training Programme on Cardiovascular Fitness, Energy Cost of Walking and Fatigue in Prior Polio Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271530
• Other study ID #: RoyalCSI DMurray
• Status: Completed
• Phase: N/A
• First received: December 10, 2010
• Last updated: September 18, 2013
• Start date: July 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of upper limb cardiovascular training on fitness, energy cost of walking, fatigue and pain in polio survivors. Polio survivors often have difficulty accessing aerobic forms of exercise due to limitations in mobility, pain associated with walking and fatigue. This can result in becoming physically unfit and places polio survivors at risk of secondary heath problems due to inactivity. A large percentage of polio survivors have lower limb involvement but have strong arms. The participants in this study will exercise at home using simple arm cycles for 8 weeks. They will attend for assessment on two occasions. All exercise will be prescribed by a Physiotherapist and includes measures to ensure safety while exercising at home.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• A confirmed history of Poliomyelitis affecting at least one lower limb, confirmed by the consultant Neurologist, Beaumont Hospital, Dublin, and documented in the medical chart.

• Capable of walking for 6 minutes, with or without an aid or appliance (as reported by the patient).

• Good upper limb strength, confirmed objectively by Quantitative Muscle Analysis (QMA) (Maximum Voluntary Isometric Contraction (MVIC)). MVIC scores of 7 out of 10 tested upper limb movements must lie above the 5th percentile of the normal range.

• Completion of the Physical Activity Readiness Questionnaire (PAR-Q) and cleared by medical practitioner as safe for exercise if indicated.

• Aged > 18 and < 75 NOTE: Participants must be resident in Ireland.

Exclusion Criteria:

• History of unstable cardiac or respiratory conditions

• Uncontrolled hypertension

• Oxygen dependence

• Significant upper limb pain (Visual Analogue Scale > 4 or more than 3 specific sites of pain)

• Severe fatigue (Fatigue Severity Scale > 5)

• Recent onset of upper limb weakness or severe upper limb weakness (< 5th percentile on more than 3 tested upper limb movements, either reported by the patient or measured using Quantitative Muscle assessment.

• Steroid use in last 3 months

• Use of medications which may influence cardiovascular testing (Beta-blockers etc)

• Pregnant Women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postpoliomyelitis Syndrome

Intervention

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.

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin

Sponsors (3)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Beaumont Hospital, Post Polio Support Group Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six Minute Arm Test	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.	Eight weeks	No
Primary	The Physical Activity Scale for Persons with Physical Disabilities	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).	Eight weeks	No
Secondary	Upper Limb Maximal Voluntary Isometric Contraction	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.	Eight weeks	No
Secondary	Body Mass Index and Waist to hip Ratio	Body composition will be assessed using Body Mass Index and Waist to hip ratio will be used to measure risk due to overweight / obesity.	Eight weeks	No
Secondary	Hand Grip Motor Fatigue	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.	Eight weeks	No
Secondary	Short Form 36 Version 2 (SF-36 v2)	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)	Eight weeks	No
Secondary	Short Form McGill Pain Questionnaire version 2 (SF-MPQ-2)	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).	Eight weeks	No
Secondary	Physiological Cost Index	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.	Eight weeks	No
Secondary	The Fatigue Severity Scale	The Fatigue Severity Scale is a commonly used questionnaire used to assess subjective fatigue	Eight weeks	No