The Effect of Exercise Training on Gait and Quality of Life in Parkinson's Disease

Study Overview
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Brief Summary
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The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and without a strengthening component, on functional mobility, gait and quality of life in patients with Parkinson's disease (PD). The rationale for a study of this type stems from the hypothesis that treadmill training may act as an external pacemaker and enhance some properties of gait. There is a need for larger scale randomized controlled trials comparing the effects of treadmill training to control groups that receive similar amounts of attention. To date, no study has combined TT and muscle strengthening, likely the optimal form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of 72 one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill training will considerably improve walking parameters and the well being of people with PD.

Official Title
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The Effect of Exercise Training on Gait and Quality of Life in Patients With Early Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Walking on treadmill
* Other: Walking on treadmill
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic Parkinson's disease Stage of II or less on Hoehn and Yahr scale Exclusion Criteria: Having musculoskeletal impairments or having excessive pain in any joint that could limit participation in exercise program Dementia (MMSE<24) Having balance problems Live beyond 45 minutes from Laval University

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Speed TT<br>Walk on treadmill with progressive increases in speed | Other: Walking on treadmill<br>* 3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, subjects in the Speed TT had an increase in speed, depending on exercise tolerance of each participant. The TT velocity was increased by 0,2 km/h when the participant reached criteria.<br>|
| Experimental: Mixed TT<br>Walk on treadmill with progressive increases in speed and incline | Other: Walking on treadmill<br>* 3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, the TT velocity was increased by 0,2 km/h or the incline of the walking surface of TT was increased by 1% alternately when the progression criteria were met.<br>|
| Active Comparator: Control<br>Light-intensity exercise group, work flexibility and coordination | Other: Control group<br>* Training of the control group was characterized by light intensity exercises. For the first three months, participants performed regular exercise involving full range of motion to enhance their flexibility. For the last three months of the training programme, participants learned elements of Tai Chi and rhythmic movements of latin dance. Participants attended two 1-h supervised sessions per week and were asked to perform each week a third session at home, based on instructions in a document offered to the control group participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gait speed | This measure was recorded using the GAITrite system | Baseline, 3 and 6 months | 
| Change in Endurance walking | This measure was recorded using the 6-minutes walk test | Baseline, 3 and 6 months | 
| Change in Quality of life | This measure was recorded using PDQ-39 | Baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Postural Balance | This measure was recorded using force platform PRO Balance Master® | Baseline, 3 and 6 months | 
| Change in Spatiotemporal parameters of walking | This measure was recorded using the GAITrite system | Baseline, 3 and 6 months | 
| Change in Cognitive impairment | This measure was recorded using Mini-Mental State Examination | Baseline, 3 and 6 months | 
| Change in Fear of falling | This measure was recorded using the ABC Scale | Baseline, 3 and 6 months | 
| Change in Depression and anxiety level | This measure was recorded using BDI-II | Baseline, 3 and 6 months | 
| Change in Effects of symptoms and motor impairment | This measure was recorded using the UPDRS | Baseline, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, treadmill training, rehabilitation