Parkinson Disease
Conditions
Keywords
adapted physical activity, gait, quality of life, actimetry, Parkinson's disease
Brief summary
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.
Interventions
BEHAVIORALPhysical training
Supervised gait training program 3 times a week, 12 weeks
Sponsors
University Grenoble Alps
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The researchers involved in data collection and in data analysis will be blinded with regard to the patients' group allocation. Randomization will be performed by an operator not otherwise involved in the study, under the RED-Cap application.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in daily energy expenditure | recording 7 days in a row, at 3 months, 6 months and 9 months. | Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of gait parameters | 3 months, 6 months and 9 months. | Evolution over time of spatio-temporal gait parameters recorded during a gait test in the laboratory. |
| Evolution of exercise functional capacity | 3 months, 6 months and 9 months. | Evolution over time of the patients' performance at the 6 minutes walk test |
| Evolution over time of the Parkinson's Disease Questionnaire-39 scale score. | 3 months, 6 months and 9 months. | Evolution of quality of life as measured using the PDQ.39 scale. Summed item scores expressed as percent. Min 0 Max 100. |
| Evolution over time of the Parkinsons' Disease Fatigue Scale score. | 3 months, 6 months and 9 months. | Evolution of fatigue as measured using the PD Fatigue scale. Min 0. Max 80. Greater score means greater fatigue |
| Adherence to the training program | 3 months | number of training sessions attended |
Countries
France
Outcome results
None listed