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The Purpose of This Pilot Study is to Investigate the Impact of a Weekly Community Exercise Group (BIG for Life) on Motor Function (i.e. Balance, Gait, Strength, Balance Confidence), Ability to Perform Activities of Daily Living, and Quality of Life Measures in Individuals With Parkinson's Disease.

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ClinicalTrials.gov Identifier: NCT04090476
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Amy DeBlois, State University of New York - Upstate Medical University

Brief Summary:

BIG for Life is a a Community-based Weekly Exercise Group for Individuals With Parkinson's Disease With a Focus on Improving Ability to Walk, Balance, and Perform Daily Activities With an Emphasis on "Moving Big". The Purpose of This Pilot Study is to Investigate the Impact of a Weekly Exercise Group on Motor Function (i.e. Balance, Gait, Strength, Balance Confidence), Ability to Perform Activities of Daily Living, and Quality of Life Measures Such as Sleep and Depression in Individuals With Parkinson's Disease.

We will test the hypotheses that participation in this exercise group may:

  1. improve mobility level and balance confidence
  2. improve performance of activities of daily living
  3. improve quality of life, sleep, or depression

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BIG for Life: a Pilot Study
Estimated Study Start Date : September 13, 2019
Estimated Primary Completion Date : September 13, 2020
Estimated Study Completion Date : September 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIG for Life Exercise Group
This arm includes the entire cohort enrolled who will participate in the weekly one hour community exercise group for a total of 8 weeks
Other: Exercise
Enrolled subjects will participate in a 8-week series of peer group exercise sessions. Each class will last one hour and will be facilitated by a physical therapist and physical therapy students. During each session, the daily exercises as part of the LSVT Big program will be performed and modified to the participant's ability level, along with performance of functional tasks stations (i.e. putting on a jacket, putting on a sock, etc.) which will rotate weekly to monthly, and gait tasks (i.e. forward, backwards, stepping over obstacles).




Primary Outcome Measures :
  1. PDQ-39 [ Time Frame: 8 weeks ]
    Quality of Life Measure for PD

  2. PHQ-9 [ Time Frame: 8 weeks ]
    Depression Measure

  3. PDSS-2 [ Time Frame: 8 weeks ]
    Sleep Measure for PD

  4. ABC [ Time Frame: 8 weeks ]
    Measure of Balance Confidence

  5. Functional Tasks Recording Form [ Time Frame: 8 weeks ]
    Measure of Activities of Daily Living

  6. 10 meter walk test [ Time Frame: 8 weeks ]
    Gait speed

  7. 6 minute walk test [ Time Frame: 8 weeks ]
    endurance measure

  8. 5 times sit to stand [ Time Frame: 8 weeks ]
    Lower extremity strength measure

  9. Mini-BESTest [ Time Frame: 8 weeks ]
    Balance Measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People with Parkinson's disease age 18 or over, male or female will be included.

Exclusion Criteria:

  • Persons under the age of 18 and those without a diagnosis of Parkinson's disease will be excluded from the study. Individuals with PD who are bed bound or wheelchair bound will be excluded. Scores of <23 on the MOCA will be excluded due to risk of cognitive impairments which may limit participation and ability to consent. Participants must be cleared for participation in the community exercise program by their physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090476


Contacts
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Contact: Amy DeBlois, DPT 315-464-6885 debloisa@upstate.edu

Locations
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United States, New York
Rock Steady Boxing Gym Recruiting
Liverpool, New York, United States, 13088
Contact: Amy DeBlois, DPT    315-464-6885    debloisa@upstate.edu   
Sponsors and Collaborators
State University of New York - Upstate Medical University

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Responsible Party: Amy DeBlois, Assistant Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT04090476     History of Changes
Other Study ID Numbers: 1441170
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy DeBlois, State University of New York - Upstate Medical University:
community exercise group
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases