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Parkinson DiseaseACTIPARKNCT03244813

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

A study testing Personalized activity program in people with Parkinson Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Personalized activity program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteFrance
Study dates
10 Jan 2018to 2 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Nimes

    Nîmes, 30029

Other trials in France

About this study

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.

Being tested
Personalized activity program
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized activity programOther

    Targeted physical activity

Study groups in NCT03244813
Study groupRoleWhat they receive
Adapted physical activityExperimentalNot described
Receives: Other: Personalized activity program
Standard careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (22)

  1. Activity of patients in both groups

    previous weeks' activity measured by actigraphy

    Measured: 6 months

  2. Activity of patients in both groups

    assessed by international physical activity questionnaire

    Measured: 6 months

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

    Assessed by PDG-39 questionnaire

    Measured: 3 months

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

    Assessed by PDG-39 questionnaire

    Measured: 6 months

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

    measured by Timed Up and Go test

    Measured: 3 months

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

    measured by Timed Up and Go test

    Measured: 6 months

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

    measured by Tinetti Falls Efficacy Scale

    Measured: 3 months

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

    measured by Tinetti Falls Efficacy Scale

    Measured: 6 months

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

    measured by 0-10 scale

    Measured: 3 months

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

    measured by 0-10 scale

    Measured: 6 months

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

    6 minute walk test

    Measured: 3 months

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

    6 minute walk test

    Measured: 6 months

  13. Activity of the care giver

    previous weeks' activity measured by actigraphy

    Measured: 3 months

  14. Activity of the care giver

    previous weeks' activity measured by actigraphy

    Measured: 6 months

  15. Evaluation of the care burden of care giver

    Zarit scale

    Measured: 3 months

  16. Evaluation of the care burden of care giver

    Zarit scale

    Measured: 6 months

  17. Grip strength

    Pinch test

    Measured: Day 0

  18. Grip strength

    Pinch test

    Measured: 6 months

  19. Patient dependence

    Activities of Daily Living

    Measured: Day 0

  20. Patient dependence

    Activities of Daily Living

    Measured: 6 months

  21. Level of dementia at Day

    Instrumental Activities of Daily Living

    Measured: Day 0

  22. Level of dementia at Day

    Instrumental Activities of Daily Living

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2017
  2. Study start10 Jan 2018
  3. Primary completion2 Dec 2019
  4. Study completion2 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244813
Sponsor's protocol ID
NIMAO/2016/EV-01
Acronym
ACTIPARK
Status last verified
Jan 2020
First submitted
16 Jun 2017
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38588457

  • 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.

    PubMed 36602886

Questions about this trial

What is this clinical trial studying?

A study testing Personalized activity program in people with Parkinson Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03244813, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.

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