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Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease

2. august 2022 opdateret af: Ithaca College

Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease

This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. The impact of participation in this program on motor function, postural control, gait, quality of life, and self-efficacy for exercise will be measured.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This program will be delivered 2 times per week for 8 weeks with examination of outcome measures prior to and after completion. The investigators plan to enroll 20 participants with 10 completing a group program led by a physical therapist and 10 completing an individual exercise program led by a physical therapist.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • New York
      • Ithaca, New York, Forenede Stater, 14850
        • Sarah Fishel

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • have a diagnosis of idiopathic Parkinson disease
  • been prescribed a stable dose of levadopa medication for at least 4 weeks prior to study participation
  • be able to walk independently
  • have a referral from a physician to participate in the program
  • have access to a computer/tablet/or phone to use for telehealth sessions with reliable internet and access to the Zoom platform

Exclusion Criteria:

  • have any other neurological condition other than Parkinson disease
  • have a score less than 20/28 on the Mini-Balance Systems Evaluation Test (reflecting a higher risk of falls)
  • demonstrate unstable/unsafe blood pressure or heart rate responses during the initial evaluation with response to submaximal exercise
  • have any musculoskeletal condition that affected their ability to participate in the exercise group
  • score less than 24/30 on the Mini Mental Status Examination during the initial evaluation

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Individual Exercise Instruction
The participant will receive individual exercise instruction.
Andet: Multidimensional Exercise Program
The multidirectional exercise program will include cardiovascular training, strengthening, balance training, and flexibility training. This will be delivered 2 times per week for 8 weeks using telehealth and will be delivered by a physical therapist. The exercises will be modified to meet the participants needs. Intensity of exercise interventions will be monitored through patient self report and use of continuous heart rate monitoring.
Eksperimentel: Group Exercise Instruction
The participant will receive the instruction in a group of up to 9 other participants.
Andet: Multidimensional Exercise Program
The multidirectional exercise program will include cardiovascular training, strengthening, balance training, and flexibility training. This will be delivered 2 times per week for 8 weeks using telehealth and will be delivered by a physical therapist. The exercises will be modified to meet the participants needs. Intensity of exercise interventions will be monitored through patient self report and use of continuous heart rate monitoring.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in "Mini-Balance Evaluation Systems Test" Score
Tidsramme: Prior to and after the 8 week intervention.
This is a 14 item outcome measure that examines postural control in standing. The measure includes items that assess anticipatory postural control, reactive postural control, somatosensory integration, and dynamic gait. The scores range from 0-28 points with 28 reflecting the best possible balance performance.
Prior to and after the 8 week intervention.
Change in "Five Times Sit to Stand" test time
Tidsramme: Prior to and after the 8 week intervention.
For this outcome the participant is asked to perform sitting to standing transitions 5 times as quickly as possible. The time to complete the task is recorded. A lower time is associated with faster and more agile performance with sitting to standing transitions.
Prior to and after the 8 week intervention.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 10 meter walk test
Tidsramme: Prior to and after 8 week intervention.
This outcome measure examines gait speed at comfortable and fast speeds. This will be performed using the Gait Rite mat which will collect information about gait characteristics, including step length, step width, and gait symmetry as well. A faster time is associated with better balance and walking ability.
Prior to and after 8 week intervention.
Change in Six Minute Walk Test Distance
Tidsramme: Prior to and after 8 week intervention.
This outcome examines gait endurance by measuring the distance walked over 6 minutes on a level surface. A greater number of meters on the test is associated with better walking endurance.
Prior to and after 8 week intervention.
Change in Parkinson Disease Questionnaire-39 score
Tidsramme: Prior to and after 8 week intervention.
This is a self report quality of life measure designed for individuals with Parkinson disease. There are 8 subsections which can be reported individually and the score can be calculated as a summary score out of 100%. A lower percentage is associated with lower disability related to Parkinson disease.
Prior to and after 8 week intervention.
Change in Self Efficacy for Exercise Scale score
Tidsramme: Prior to and after 8 week intervention.
This measures a person's confidence that they will exercise in a variety of situations.The score ranges from 0 to 90 with a higher score associated with a higher self efficacy for exercise behavior.
Prior to and after 8 week intervention.

Samarbejdspartnere og efterforskere

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

Sponsor

Ithaca College

Samarbejdspartnere

Parkinson's Foundation

Efterforskere

  • Ledende efterforsker: Sarah Fishel, Faculty

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)

7. juni 2021

Primær færdiggørelse (Faktiske)

1. august 2022

Studieafslutning (Faktiske)

1. august 2022

Datoer for studieregistrering

Først indsendt

1. juni 2021

Først indsendt, der opfyldte QC-kriterier

4. juni 2021

Først opslået (Faktiske)

8. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 271

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Kliniske forsøg med Parkinsons sygdom

Kliniske forsøg med Multidimensional Exercise Program

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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