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

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

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Walking on treadmill; Other: Walking on treadmill; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 0A6
    • Laval University
  • Quebec, Canada, G1S 2M5
    • Quebec Memory and Motor Skills Disorders Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Speed TT; Walk on treadmill with progressive increases in speed	Other: Walking on treadmill; 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.; Other: Walking on treadmill; 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.
Experimental: Mixed TT; Walk on treadmill with progressive increases in speed and incline	Other: Walking on treadmill; 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.; Other: Walking on treadmill; 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.
Active Comparator: Control; Light-intensity exercise group, work flexibility and coordination	Other: Control group; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Study Director: Philippe Corbeil, Laval University; Study Director: Alexandra Nadeau, Laval University; Principal Investigator: Emmanuelle Pourcher, Quebec Memory and Motor Skills Disorders Research Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 18, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): October 4, 2012
• Last Update Submitted That Met QC Criteria: October 3, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Physical activity, treadmill training, rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: TTPD-2011