Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson

Study Overview
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Brief Summary
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The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD). Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point. The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function. Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.

Official Title
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Impact de Programmes de Marche Active Sur la Marche en Situation de Vie Quotidienne et la qualité de Vie Dans la Maladie de Parkinson

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Physical training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease, diagnosed for at least 2 years, Medical treatment (if any) unchanged in the past 4 weeks at least Hoehn & Yahr score < 3 Montreal cognitive assessment (MOCA) score between 20 and 30 Able to understand the aim and methods of the study and provide signed informed consent- Exclusion Criteria: Atypical parkinsonian syndrome Cardiovascular pathology preventing moderate physical exercise Orthostatic hypotension Any condition (other than PD) interfering with gait pregnant or nursing

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill walking<br>The training program will last 12 weeks and consist of treadmill walking. The duration of the walking bouts (and pauses), and the speed of the belt will be adjusted as needed following the patients' progress. Music will be added as suited to boost motivation and support regular cadence. All training sessions will be supervised. | Behavioral: Physical training<br>* Supervised gait training program 3 times a week, 12 weeks<br>|
| Experimental: Nordic walking<br>The training program will last 12 weeks and consist of Nordic walking, taught and supervised by an adapted physical activity teacher. The session will be carried out outside, weather permitting. When possible, training will gather 2 to 4 patients for group emulation. The duration of the walking bouts (and pauses) will be adjusted to follow the patients' progress. | Behavioral: Physical training<br>* Supervised gait training program 3 times a week, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in daily energy expenditure | Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt. | recording 7 days in a row, at 3 months, 6 months and 9 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of gait parameters | Evolution over time of spatio-temporal gait parameters recorded during a gait test in the laboratory. | 3 months, 6 months and 9 months. | 
| Evolution of exercise functional capacity | Evolution over time of the patients' performance at the 6 minutes walk test | 3 months, 6 months and 9 months. | 
| Evolution over time of the Parkinson's Disease Questionnaire-39 scale score. | Evolution of quality of life as measured using the PDQ.39 scale. Summed item scores expressed as percent. Min 0 Max 100. | 3 months, 6 months and 9 months. | 
| Evolution over time of the Parkinsons' Disease Fatigue Scale score. | Evolution of fatigue as measured using the PD Fatigue scale. Min 0. Max 80. Greater score means greater fatigue | 3 months, 6 months and 9 months. | 
| Adherence to the training program | number of training sessions attended | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adapted physical activity, gait, quality of life, actimetry, Parkinson's disease