Clinical trial NCT01271530: Arm Cycling to Improve Fitness in Polio Survivors
Official title: The Impact of an Arm Ergometry Training Programme on Cardiovascular Fitness, Energy Cost of Walking and Fatigue in Prior Polio Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpoliomyelitis Syndrome
Keywords: Late Effects of Polio
Cardiovascular Fitness
Fatigue
Energy cost of Walking
Pain
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Post Polio Support Group Ireland
name: Beaumont Hospital
First posted: 2011-01-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Six Minute Arm Test
timeFrame: Eight weeks
measure: The Physical Activity Scale for Persons with Physical Disabilities
timeFrame: Eight weeks
Secondary outcomes:
measure: Upper Limb Maximal Voluntary Isometric Contraction
timeFrame: Eight weeks
measure: Body Mass Index and Waist to hip Ratio
timeFrame: Eight weeks
measure: Hand Grip Motor Fatigue
timeFrame: Eight weeks
measure: Short Form 36 Version 2 (SF-36 v2)
timeFrame: Eight weeks
measure: Short Form McGill Pain Questionnaire version 2 (SF-MPQ-2)
timeFrame: Eight weeks
measure: Physiological Cost Index
timeFrame: Eight weeks
measure: The Fatigue Severity Scale
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Royal College of Surgeons in Ireland
name: Deirdre E Murray, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College of Surgeons in Ireland
name: Dara Meldrum, MSc
role: STUDY_DIRECTOR
affiliation: Royal College of Surgeons in Ireland
name: Frances Horgan, PhD
role: STUDY_DIRECTOR
affiliation: Beaumont Hospital
name: Orla Hardiman, MD
role: STUDY_CHAIR
affiliation: Beaumont Hospital
name: Roisin Moloney, BSc
role: STUDY_DIRECTOR
References:
citation: Murray D, Meldrum D, Moloney R, Campion A, Horgan F, Hardiman O. The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial. BMC Neurol. 2012 Dec 13;12:157. doi: 10.1186/1471-2377-12-157.