Suspended

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

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What is being tested

Walking on treadmill

+ Walking on treadmill

+ Control group

Other
Who is being recruted

Synucleinopathies+8

+ Basal Ganglia Diseases

+ Behavior

From 40 to 80 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2010
See protocol details

Summary

Principal SponsorLaval University
Last updated: October 4, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01701128
Principal SponsorLaval University
Last updated: October 4, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBehaviorBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesNeurodegenerative DiseasesParkinsonian DisordersMotor ActivityParkinson Disease

Criteria

2 inclusion criteria required to participate
Diagnosis of idiopathic Parkinson's disease
Stage of II or less on Hoehn and Yahr scale
4 exclusion criteria prevent from participating
Dementia (MMSE < 24)
Having balance problems
Having musculoskeletal impairments or having excessive pain in any joint that could limit participation in exercise program
Live beyond 45 minutes from Laval University

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Walk on treadmill with progressive increases in speed

Group II

Experimental
Walk on treadmill with progressive increases in speed and incline

Group III

Active Comparator
Light-intensity exercise group, work flexibility and coordination

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Quebec Memory and Motor Skills Disorders Research Center

Québec, CanadaOpen Quebec Memory and Motor Skills Disorders Research Center in Google Maps

Laval University

Québec, Canada
Suspended2 Study Centers