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Arm Cycling to Improve Fitness in Polio Survivors

Primary Purpose

Postpoliomyelitis Syndrome

Status

Completed

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

Upper Limb Ergometry

About this trial

This is an interventional treatment trial for Postpoliomyelitis Syndrome focused on measuring Late Effects of Polio, Cardiovascular Fitness, Fatigue, Energy cost of Walking, Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

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.

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.

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.

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)

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).

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.

The Fatigue Severity Scale

The Fatigue Severity Scale is a commonly used questionnaire used to assess subjective fatigue

Full Information

NCT ID

NCT01271530

First Posted

December 10, 2010

Last Updated

September 18, 2013

Sponsor

Royal College of Surgeons, Ireland

Collaborators

Post Polio Support Group Ireland, Beaumont Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01271530

Brief Title

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

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Royal College of Surgeons, Ireland

Collaborators

Post Polio Support Group Ireland, Beaumont Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpoliomyelitis Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Upper Limb Ergometry

Intervention Description

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.

Primary Outcome Measure Information:

Title

Six Minute Arm Test

Description

Time Frame

Eight weeks

Title

The Physical Activity Scale for Persons with Physical Disabilities

Description

Time Frame

Eight weeks

Secondary Outcome Measure Information:

Title

Upper Limb Maximal Voluntary Isometric Contraction

Description

Time Frame

Eight weeks

Title

Body Mass Index and Waist to hip Ratio

Description

Body composition will be assessed using Body Mass Index and Waist to hip ratio will be used to measure risk due to overweight / obesity.

Time Frame

Eight weeks

Title

Hand Grip Motor Fatigue

Description

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.

Time Frame

Eight weeks

Title

Short Form 36 Version 2 (SF-36 v2)

Description

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)

Time Frame

Eight weeks

Title

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

Description

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).

Time Frame

Eight weeks

Title

Physiological Cost Index

Description

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.

Time Frame

Eight weeks

Title

The Fatigue Severity Scale

Description

The Fatigue Severity Scale is a commonly used questionnaire used to assess subjective fatigue

Time Frame

Eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials: