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

Primary Purpose

Parkinson Disease

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical training
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring adapted physical activity, gait, quality of life, actimetry, Parkinson's disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Grenoble Alpes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treadmill walking

Nordic walking

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evolution of gait parameters
Evolution over time of spatio-temporal gait parameters recorded during a gait test in the laboratory.
Evolution of exercise functional capacity
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.
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.
Evolution of fatigue as measured using the PD Fatigue scale. Min 0. Max 80. Greater score means greater fatigue
Adherence to the training program
number of training sessions attended

Full Information

First Posted
September 1, 2022
Last Updated
April 3, 2023
Sponsor
University Hospital, Grenoble
Collaborators
University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT05685095
Brief Title
Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
personnel involved in clinical trial will not be available to conduct the research
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
adapted physical activity, gait, quality of life, actimetry, Parkinson's disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill walking
Arm Type
Experimental
Arm Description
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.
Arm Title
Nordic walking
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical training
Intervention Description
Supervised gait training program 3 times a week, 12 weeks
Primary Outcome Measure Information:
Title
Changes in daily energy expenditure
Description
Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt.
Time Frame
recording 7 days in a row, at 3 months, 6 months and 9 months.
Secondary Outcome Measure Information:
Title
Evolution of gait parameters
Description
Evolution over time of spatio-temporal gait parameters recorded during a gait test in the laboratory.
Time Frame
3 months, 6 months and 9 months.
Title
Evolution of exercise functional capacity
Description
Evolution over time of the patients' performance at the 6 minutes walk test
Time Frame
3 months, 6 months and 9 months.
Title
Evolution over time of the Parkinson's Disease Questionnaire-39 scale score.
Description
Evolution of quality of life as measured using the PDQ.39 scale. Summed item scores expressed as percent. Min 0 Max 100.
Time Frame
3 months, 6 months and 9 months.
Title
Evolution over time of the Parkinsons' Disease Fatigue Scale score.
Description
Evolution of fatigue as measured using the PD Fatigue scale. Min 0. Max 80. Greater score means greater fatigue
Time Frame
3 months, 6 months and 9 months.
Title
Adherence to the training program
Description
number of training sessions attended
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moro Elena, MD PhD
Organizational Affiliation
Grenoble Alpes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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