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

NCT05685095 | Withdrawn DMC

• 2 other identifiers: 38RC22.0105_ACTI-PARK2022-A00678-35
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

adapted physical activity; gait; quality of life; actimetry; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evolution of gait parameters

  3 months, 6 months and 9 months.

• Evolution of exercise functional capacity

  3 months, 6 months and 9 months.

• Evolution over time of the Parkinson's Disease Questionnaire-39 scale score.

  3 months, 6 months and 9 months.

• Evolution over time of the Parkinsons' Disease Fatigue Scale score.

  3 months, 6 months and 9 months.

• Adherence to the training program

  3 months

Study Arms (2)

Treadmill walking

EXPERIMENTAL

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

Nordic walking

EXPERIMENTAL

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

Interventions

Physical training BEHAVIORAL

Supervised gait training program 3 times a week, 12 weeks

Nordic walking; Treadmill walking

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• Atypical parkinsonian syndrome
• Cardiovascular pathology preventing moderate physical exercise
• Orthostatic hypotension
• Any condition (other than PD) interfering with gait
• pregnant or nursing

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Grenoble Alps: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Moro Elena, MD PhD

  Grenoble Alpes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: January 13, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)