Arm Cycling to Improve Fitness in Polio Survivors

NCT01271530 | Completed

• 1 other identifier: RoyalCSI DMurray
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpoliomyelitis Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (7)

• Upper Limb Maximal Voluntary Isometric Contraction

  Eight weeks

• Body Mass Index and Waist to hip Ratio

  Eight weeks

• Hand Grip Motor Fatigue

  Eight weeks

• Short Form 36 Version 2 (SF-36 v2)

  Eight weeks

• Short Form McGill Pain Questionnaire version 2 (SF-MPQ-2)

  Eight weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Other: Upper Limb Ergometry

Control

NO INTERVENTION

Interventions

Upper Limb Ergometry 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.

Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Post Polio Support Group Ireland: collaborator
• Beaumont Hospital: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, D 9, Ireland

Location

Related Publications (1)

• 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.

  PMID: 23234560 DERIVED

MeSH Terms

Conditions

Postpoliomyelitis Syndrome; Fatigue; Pain

Condition Hierarchy (Ancestors)

Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Deirdre E Murray, BSc

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

• Dara Meldrum, MSc

  Royal College of Surgeons in Ireland

  STUDY DIRECTOR

• Frances Horgan, PhD

  Royal College of Surgeons in Ireland

  STUDY DIRECTOR

• Orla Hardiman, MD

  Beaumont Hospital

  STUDY CHAIR

• Roisin Moloney, BSc

  Beaumont Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Specialist Physiotehrapist in Neurosciences and PhD student

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: January 6, 2011
• Study Start: July 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 19, 2013

Record last verified: 2013-09

Locations

IE (1)