Arm Cycling to Improve Fitness in Polio Survivors

NCT ID: NCT01271530

Last Updated: 2013-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-09-30

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.

Conditions

Postpoliomyelitis Syndrome

Keywords

Late Effects of Polio; Cardiovascular Fitness; Fatigue; Energy cost of Walking; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise

Group Type: EXPERIMENTAL

Upper Limb Ergometry

Intervention Type: OTHER

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Polio Support Group Ireland

UNKNOWN

Sponsor Role: collaborator

Beaumont Hospital

OTHER

Sponsor Role: collaborator

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Deirdre Murray

Clinical Specialist Physiotehrapist in Neurosciences and PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deirdre E Murray, BSc

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons in Ireland

Dara Meldrum, MSc

Role: STUDY_DIRECTOR

Royal College of Surgeons in Ireland

Frances Horgan, PhD

Role: STUDY_DIRECTOR

Royal College of Surgeons in Ireland

Orla Hardiman, MD

Role: STUDY_CHAIR

Beaumont Hospital

Roisin Moloney, BSc

Role: STUDY_DIRECTOR

Beaumont Hospital

Locations

Beaumont Hospital

Dublin, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 23234560 (View on PubMed)

Other Identifiers

RoyalCSI DMurray

Identifier Type: -

Identifier Source: org_study_id