The Effect of Exercise Training on Gait and Quality of Life in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Walking on treadmill
Walking on treadmill
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Physical activity, treadmill training, rehabilitation
Eligibility Criteria
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
Sites / Locations
- Quebec Memory and Motor Skills Disorders Research Center
- Laval University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Speed TT
Mixed TT
Control
Arm Description
Walk on treadmill with progressive increases in speed
Walk on treadmill with progressive increases in speed and incline
Light-intensity exercise group, work flexibility and coordination
Outcomes
Primary Outcome Measures
Change in Gait speed
This measure was recorded using the GAITrite system
Change in Endurance walking
This measure was recorded using the 6-minutes walk test
Change in Quality of life
This measure was recorded using PDQ-39
Secondary Outcome Measures
Change in Postural Balance
This measure was recorded using force platform PRO Balance Master®
Change in Spatiotemporal parameters of walking
This measure was recorded using the GAITrite system
Change in Cognitive impairment
This measure was recorded using Mini-Mental State Examination
Change in Fear of falling
This measure was recorded using the ABC Scale
Change in Depression and anxiety level
This measure was recorded using BDI-II
Change in Effects of symptoms and motor impairment
This measure was recorded using the UPDRS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01701128
Brief Title
The Effect of Exercise Training on Gait and Quality of Life in Parkinson's Disease
Official Title
The Effect of Exercise Training on Gait and Quality of Life in Patients With Early Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Protocol is completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Physical activity, treadmill training, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Speed TT
Arm Type
Experimental
Arm Description
Walk on treadmill with progressive increases in speed
Arm Title
Mixed TT
Arm Type
Experimental
Arm Description
Walk on treadmill with progressive increases in speed and incline
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Light-intensity exercise group, work flexibility and coordination
Intervention Type
Other
Intervention Name(s)
Walking on treadmill
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Walking on treadmill
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Gait speed
Description
This measure was recorded using the GAITrite system
Time Frame
Baseline, 3 and 6 months
Title
Change in Endurance walking
Description
This measure was recorded using the 6-minutes walk test
Time Frame
Baseline, 3 and 6 months
Title
Change in Quality of life
Description
This measure was recorded using PDQ-39
Time Frame
Baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Change in Postural Balance
Description
This measure was recorded using force platform PRO Balance Master®
Time Frame
Baseline, 3 and 6 months
Title
Change in Spatiotemporal parameters of walking
Description
This measure was recorded using the GAITrite system
Time Frame
Baseline, 3 and 6 months
Title
Change in Cognitive impairment
Description
This measure was recorded using Mini-Mental State Examination
Time Frame
Baseline, 3 and 6 months
Title
Change in Fear of falling
Description
This measure was recorded using the ABC Scale
Time Frame
Baseline, 3 and 6 months
Title
Change in Depression and anxiety level
Description
This measure was recorded using BDI-II
Time Frame
Baseline, 3 and 6 months
Title
Change in Effects of symptoms and motor impairment
Description
This measure was recorded using the UPDRS
Time Frame
Baseline, 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Corbeil
Organizational Affiliation
Laval University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexandra Nadeau
Organizational Affiliation
Laval University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emmanuelle Pourcher
Organizational Affiliation
Quebec Memory and Motor Skills Disorders Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quebec Memory and Motor Skills Disorders Research Center
City
Quebec
ZIP/Postal Code
G1S 2M5
Country
Canada
Facility Name
Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
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The Effect of Exercise Training on Gait and Quality of Life in Parkinson's Disease
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