Skip to main content
OpenTrials
Completed

NCT Number: NCT03244813

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • The subject and/or their caregiver is participating in another study
  • The subject and/or their caregiver is in a period of exclusion determined by a previous 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

Treatment and study plan

Personalized activity program

Other

Targeted physical activity

Primary outcomes

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

    Time frame: 3 months

    previous weeks' activity measured by actigraphy

Secondary outcomes

  1. Activity of patients in both groups

    Time frame: 6 months

    previous weeks' activity measured by actigraphy

  2. Activity of patients in both groups

    Time frame: 6 months

    assessed by international physical activity questionnaire

  3. Quality of life of patients undertaking APA verses standard care

    Time frame: 3 months

    Assessed by PDG-39 questionnaire

  4. Quality of life of patients undertaking APA verses standard care

    Time frame: 6 months

    Assessed by PDG-39 questionnaire

  5. Risk of fall of patients undertaking APA verses standard care

    Time frame: 3 months

    measured by Timed Up and Go test

  6. Risk of fall of patients undertaking APA verses standard care

    Time frame: 6 months

    measured by Timed Up and Go test

  7. Risk of fall of patients undertaking APA verses standard care

    Time frame: 3 months

    measured by Tinetti Falls Efficacy Scale

  8. Risk of fall of patients undertaking APA verses standard care

    Time frame: 6 months

    measured by Tinetti Falls Efficacy Scale

  9. Risk of fall of patients undertaking APA verses standard care

    Time frame: 3 months

    measured by 0-10 scale

  10. Risk of fall of patients undertaking APA verses standard care

    Time frame: 6 months

    measured by 0-10 scale

  11. Endurance and speed of walking of patients undertaking APA verses standard care

    Time frame: 3 months

    6 minute walk test

  12. Endurance and speed of walking of patients undertaking APA verses standard care

    Time frame: 6 months

    6 minute walk test

  13. Activity of the care giver

    Time frame: 3 months

    previous weeks' activity measured by actigraphy

  14. Activity of the care giver

    Time frame: 6 months

    previous weeks' activity measured by actigraphy

  15. Evaluation of the care burden of care giver

    Time frame: 3 months

    Zarit scale

  16. Evaluation of the care burden of care giver

    Time frame: 6 months

    Zarit scale

  17. Grip strength

    Time frame: Day 0

    Pinch test

  18. Grip strength

    Time frame: 6 months

    Pinch test

  19. Patient dependence

    Time frame: Day 0

    Activities of Daily Living

  20. Patient dependence

    Time frame: 6 months

    Activities of Daily Living

  21. Level of dementia at Day

    Time frame: Day 0

    Instrumental Activities of Daily Living

  22. Level of dementia at Day

    Time frame: 6 months

    Instrumental Activities of Daily Living

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: ACTIPARK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2017
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.