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

This study has been terminated.
(Protocol is completed)
Sponsor:
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01701128
First received: September 18, 2012
Last updated: October 3, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Parkinson's Disease
Other: Walking on treadmill
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Exercise Training on Gait and Quality of Life in Patients With Early Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in Gait speed [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using the GAITrite system

  • Change in Endurance walking [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using the 6-minutes walk test

  • Change in Quality of life [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using PDQ-39


Secondary Outcome Measures:
  • Change in Postural Balance [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using force platform PRO Balance Master®

  • Change in Spatiotemporal parameters of walking [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using the GAITrite system

  • Change in Cognitive impairment [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using Mini-Mental State Examination

  • Change in Fear of falling [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using the ABC Scale

  • Change in Depression and anxiety level [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using BDI-II

  • Change in Effects of symptoms and motor impairment [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    This measure was recorded using the UPDRS


Enrollment: 35
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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, 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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701128

Locations
Canada
Laval University
Quebec, Canada, G1V 0A6
Quebec Memory and Motor Skills Disorders Research Center
Quebec, Canada, G1S 2M5
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01701128     History of Changes
Other Study ID Numbers: TTPD-2011
Study First Received: September 18, 2012
Last Updated: October 3, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
Physical activity, treadmill training, rehabilitation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 28, 2014