Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease

NCT03244813 | Completed

• 1 other identifier: NIMAO/2016/EV-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aims to compare the effects of a standard care plan to one using adapted physical activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will allow the collection of quantitative and objective data related to activity in contrast to questionnaires which are more subjective and dependent on self-representation. In addition, the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide interesting data from this population.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease

  previous weeks' activity measured by actigraphy

  3 months

Secondary Outcomes (22)

• Activity of patients in both groups

  6 months

• Activity of patients in both groups

  6 months

• Quality of life of patients undertaking APA verses standard care

  3 months

• Quality of life of patients undertaking APA verses standard care

  6 months

• Risk of fall of patients undertaking APA verses standard care

  3 months

Study Arms (2)

Adapted physical activity

EXPERIMENTAL

Other: Personalized activity program

Standard care

NO INTERVENTION

Interventions

Personalized activity program OTHER

Targeted physical activity

Adapted physical activity

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient and their carer have given their free and informed consent and signed the consent form
• The patient must be insured of the beneficiary of an insurance policy
• The patient is available for the 6 month follow-up
• The patient is between 40 and 80 years old
• The patient has experienced symptoms of Parkinson Disease for at least 5 years and is in a stable state (no medical event or change of treatment in at least 1 month)
• The functional impact and duration of fluctuations is ≥3 (MDS UPDRS)
• The patient can walk autonomously, including using a technical aid
• The patient does not have any regular physical activity excluding physiotherapy sessions
• The patient has daily help from a caregiver

You may not qualify if:

• The subject and/or their caregiver is participating in another study
• The patients is under judicial protection or state guardianship
• It proves impossible to give the patient and/or the caregiver clear information
• The patients and/or the caregiver reuses to sign the consent form
• The patient is pregnant or breast feeding
• The patient has anxiety or depression (Score HAD≥ 11/14), cardiac or respiratory failure (stress test), vesico-sphincter problems preventing normal practice of a physical activity, a contraindication to adapted physical activities
• The patient cannot walk
• Muscular tremor preventing the actigraphy measurement. Outside normal range values for UPDRS measures of: 3.15) postural tremor of the hands; 3.16) action tremor of the hands; 3.17) amplitude of rest tremor

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (2)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The medical team assessing patient functional capacities and caregiver burden at 3 and 6 months will not know which treatment the patient received
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: August 10, 2017
• Study Start: January 10, 2018
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)