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

23. januar 2020 opdateret af: Centre Hospitalier Universitaire de Nīmes
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Nîmes, Frankrig, 30029
        • CHU Nîmes

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standard pleje
Eksperimentel: Adapted physical activity
Andet: Personalized activity program
Targeted physical activity

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease
Tidsramme: 3 months
previous weeks' activity measured by actigraphy
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Activity of patients in both groups
Tidsramme: 6 months
previous weeks' activity measured by actigraphy
6 months
Activity of patients in both groups
Tidsramme: 6 months
assessed by international physical activity questionnaire
6 months
Quality of life of patients undertaking APA verses standard care
Tidsramme: 3 months
Assessed by PDG-39 questionnaire
3 months
Quality of life of patients undertaking APA verses standard care
Tidsramme: 6 months
Assessed by PDG-39 questionnaire
6 months
Risk of fall of patients undertaking APA verses standard care
Tidsramme: 3 months
measured by Timed Up and Go test
3 months
Risk of fall of patients undertaking APA verses standard care
Tidsramme: 6 months
measured by Timed Up and Go test
6 months
Risk of fall of patients undertaking APA verses standard care
Tidsramme: 3 months
measured by Tinetti Falls Efficacy Scale
3 months
Risk of fall of patients undertaking APA verses standard care
Tidsramme: 6 months
measured by Tinetti Falls Efficacy Scale
6 months
Risk of fall of patients undertaking APA verses standard care
Tidsramme: 3 months
measured by 0-10 scale
3 months
Risk of fall of patients undertaking APA verses standard care
Tidsramme: 6 months
measured by 0-10 scale
6 months
Endurance and speed of walking of patients undertaking APA verses standard care
Tidsramme: 3 months
6 minute walk test
3 months
Endurance and speed of walking of patients undertaking APA verses standard care
Tidsramme: 6 months
6 minute walk test
6 months
Activity of the care giver
Tidsramme: 3 months
previous weeks' activity measured by actigraphy
3 months
Activity of the care giver
Tidsramme: 6 months
previous weeks' activity measured by actigraphy
6 months
Evaluation of the care burden of care giver
Tidsramme: 3 months
Zarit scale
3 months
Evaluation of the care burden of care giver
Tidsramme: 6 months
Zarit scale
6 months
Grip strength
Tidsramme: Day 0
Pinch test
Day 0
Grip strength
Tidsramme: 6 months
Pinch test
6 months
Patient dependence
Tidsramme: Day 0
Activities of Daily Living
Day 0
Patient dependence
Tidsramme: 6 months
Activities of Daily Living
6 months
Level of dementia at Day
Tidsramme: Day 0
Instrumental Activities of Daily Living
Day 0
Level of dementia at Day
Tidsramme: 6 months
Instrumental Activities of Daily Living
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. januar 2018

Primær færdiggørelse (Faktiske)

2. december 2019

Studieafslutning (Faktiske)

2. december 2019

Datoer for studieregistrering

Først indsendt

16. juni 2017

Først indsendt, der opfyldte QC-kriterier

7. august 2017

Først opslået (Faktiske)

10. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NIMAO/2016/EV-01

Plan for individuelle deltagerdata (IPD)

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