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

October 3, 2012 updated by: Laval University

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Gait speed
Time Frame: Baseline, 3 and 6 months
This measure was recorded using the GAITrite system
Baseline, 3 and 6 months
Change in Endurance walking
Time Frame: Baseline, 3 and 6 months
This measure was recorded using the 6-minutes walk test
Baseline, 3 and 6 months
Change in Quality of life
Time Frame: Baseline, 3 and 6 months
This measure was recorded using PDQ-39
Baseline, 3 and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Postural Balance
Time Frame: Baseline, 3 and 6 months
This measure was recorded using force platform PRO Balance Master®
Baseline, 3 and 6 months
Change in Spatiotemporal parameters of walking
Time Frame: Baseline, 3 and 6 months
This measure was recorded using the GAITrite system
Baseline, 3 and 6 months
Change in Cognitive impairment
Time Frame: Baseline, 3 and 6 months
This measure was recorded using Mini-Mental State Examination
Baseline, 3 and 6 months
Change in Fear of falling
Time Frame: Baseline, 3 and 6 months
This measure was recorded using the ABC Scale
Baseline, 3 and 6 months
Change in Depression and anxiety level
Time Frame: Baseline, 3 and 6 months
This measure was recorded using BDI-II
Baseline, 3 and 6 months
Change in Effects of symptoms and motor impairment
Time Frame: Baseline, 3 and 6 months
This measure was recorded using the UPDRS
Baseline, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TTPD-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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