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

Parkinson Disease Clinical Trial

— ACTI-PARK  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05685095
• Other study ID #: 38RC22.0105_ACTI-PARK
• Secondary ID: 2022-A00678-35
• Status: Withdrawn
• Phase: N/A
• Start date: February 2023
• Est. completion date: October 2026

Study information

• Verified date: April 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Physical training
Supervised gait training program 3 times a week, 12 weeks

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Institut National de la Santé Et de la Recherche Médicale, France, University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Adherence to the training program	number of training sessions attended	3 months