Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson (ACTI-PARK)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Physical training

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Chu Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treadmill walking; 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; Supervised gait training program 3 times a week, 12 weeks
Experimental: Nordic walking; 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; Supervised gait training program 3 times a week, 12 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; University Grenoble Alps
• Investigators: Principal Investigator: Moro Elena, MD PhD, Grenoble Alpes University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: gait; quality of life; Parkinson's disease; adapted physical activity; actimetry
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 38RC22.0105_ACTI-PARK; 2022-A00678-35 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No