Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease

NCT ID: NCT02816619

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-09-30

Brief Summary

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There is growing interest for physical activity in Parkinson's disease in order to improve mobility and function of these patients. It seems from previous studies that difficulty, intensity and specificity of physical exercises are important parameters conditioning the effect of physical activity on cerebral plasticity and clinical improvement.

Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity coaching program, including scheduled and frequent follow up associated with progressive readaptation of exercise intensity depending on individual performances (during 3 months), versus free practice of physical activity in Parkinson's disease.

Detailed Description

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Type of study: a randomized, single-blind, parallel-group, controlled clinical trial.

Number of centers: 1 (Clermont-Ferrand)

Patients

Patients eligible for inclusion will be randomized to one of the two groups:

* APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
* APA- : patients will do free practice of physical activity during 3 months.

Study Performance Patients will be evaluated 3 times : at J0 (baseline, V1), 3 months after Personalized Physical Activity coaching program (J0+3M, V2), and 3 months after the end of the Personalized Physical Activity coaching program (J0+6M)

V1:

* Signature of an informed consent form.
* Demographic and clinical characteristics (sex, age, disease duration, treatments).

V1, V2, V3

* Neurological evaluation (Unified Parkinson Disease Rating Scale part III score)
* Evaluation of quality of life (Parkinson's Disease Questionnaire 39-item version (PDQ-39), participation to Daily life activities (Lawton and Brody Activities of Daily Living scale (IADL questionnaire25)
* Evaluation of performances for specific tests for balance (stabilometry), muscular strength (isometry)
* Evaluation of cardiorespiratory function (VO2pic et 6 min Walk Test)
* Evaluation of body composition (lean body mass/fat mass) with DEXA.
* Dropout rates at V2 and V3
* Evaluation of the activity with the eMOUVE application in a subgroup of patients.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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APA+

APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)

Group Type EXPERIMENTAL

Personalized Physical Activity coaching program

Intervention Type BEHAVIORAL

APA-

APA- : patients will do free practice of physical activity during 3 months.

Group Type OTHER

Free practice of physical activity

Intervention Type BEHAVIORAL

Interventions

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Personalized Physical Activity coaching program

Intervention Type BEHAVIORAL

Free practice of physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical criteria for Parkinson's disease
* Men or women aged from 18 to 80 years old.
* Social security coverage.
* Ability to provide informed consent.

Exclusion Criteria

* neurological disease other than Parkinson's disease
* severe depression (Beck Depression Inventory\>37) or psychiatric comorbidities (UPDRS I )
* significant cognitive impairment (MoCA\<24)
* orthopedic impairment with functional restriction
* contraindication to physical exercise
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

OTHER

Sponsor Role collaborator

UFR STAPS

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

References

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Zanchet C, Lambert C, Boyer T, Pereira B, Derost P, Debilly B, Duclos M, Boisseau N, Marques A. Effect of an adapted physical activity program in Parkinson's disease: A randomized controlled study (APA-Park). Parkinsonism Relat Disord. 2025 May;134:107777. doi: 10.1016/j.parkreldis.2025.107777. Epub 2025 Mar 10.

Reference Type DERIVED
PMID: 40088781 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Other Identifiers

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2016-A00040-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

CHU-0265

Identifier Type: -

Identifier Source: org_study_id

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