Support + High Intensity Functional Training for Parkinson's

NCT ID: NCT05225506

Last Updated: 2023-07-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-21

Study Completion Date

2022-11-24

Brief Summary

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Parkinson's is the fastest growing neurological disorder in the world. With more people living with Parkinson's than ever before, there is an urgent need for interventions that improve health and reduce disability. High intensity exercise has shown to be superior to other forms of exercise in that it can slow symptom progression. High intensity exercise also reduces the risk of cardiovascular events. This is pertinent considering one in five people with Parkinson's will die from cardiovascular disease. While Parkinson's specific exercise programs across the U.S. continue to increase, there are still many communities with limited to no access, including Fort Smith, Arkansas. Here, there are no expert level centers within 100 miles and not a single community-based exercise program. This research will offer a community and group-based exercise program for participants with Parkinson's and their care partners.

Detailed Description

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This study, Support + High Intensity Functional Training for Parkinson's (SHIFT-PD), will provide no-cost, twice weekly, group-based, adaptable exercise programming for people with Parkinson's and their care partners. All participants will be required to have physician or advanced practice provider clearance to exercise (please see attached medical release form). All participants will be evaluated by a physical therapist at no-cost prior to beginning the intervention to assess eligibility for the study (please see methodology section below). All eligible participants will complete a demographics questionnaire requesting participant age, sex, race/ethnicity, marital status, household income, primary means of locomotion, month and/or year of Parkinson's diagnosis (people with Parkinson's only), relationship to participant with Parkinson's (care partner only). Demographic data will be utilized to describe the study population participating in the research study and to evaluate barriers and facilitators for participation. All eligible participants will undergo a battery of baseline outcome assessments prior to undergoing the exercise intervention.

Participants will participate in a maximum of twice weekly group-based exercise classes for up to 6 months. All exercise programming will be led by licensed physical therapists at a local gym, CrossFit Fort Smith. All physical therapists will be CPR/BLS certified and an automated external defibrillator will be available onsite. Exercise classes will incorporate aerobic, resistance, and/or balance training. Exercise intensity will be monitored by participant vital signs and/or participant Rating of Perceived Exertion. SHIFT-PD will follow all state, federal, and CDC guidelines regarding COVID-19 precautions.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre and post test with assessments at baseline and after 3 and 6 months of intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

In this single group design, all participants will be provided with 6 months of twice weekly supervised group exercise.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Exercise sessions will be one hour in duration and be a combination of resistance, aerobic, and balance exercise, with emphasis on movements specifically targeting common deficits seen in Parkinson's.

Interventions

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Exercise

Exercise sessions will be one hour in duration and be a combination of resistance, aerobic, and balance exercise, with emphasis on movements specifically targeting common deficits seen in Parkinson's.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants must be at least 18 years of age
* Participants must have a diagnosis of Parkinson's disease
* Participants must be able to communicate and read in English
* Participants must have physician or advanced practice provider clearance to exercise
* Participants must provide their own transportation to and from the research study
* Participants must be able to ambulate independently and/or propel a power or manual wheelchair independently


* Participants must be at least 18 years of age
* Participants must be able to communicate and read in English
* Participants must have physician or advanced practice provider clearance to exercise
* Participants must be a self-identified care partner of a person with Parkinson's participating in the study
* Participants must provide their own transportation to and from the research study
* Participants must be able to ambulate independently and/or propel a power or manual wheelchair independently
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arkansas Colleges of Health Education

OTHER

Sponsor Role lead

Responsible Party

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Reed Handlery

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reed Handlery, PhD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Colleges of Health Education

Locations

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Arkansas Colleges of Health Education

Fort Smith, Arkansas, United States

Site Status

Countries

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United States

References

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Benka Wallen M, Franzen E, Nero H, Hagstromer M. Levels and Patterns of Physical Activity and Sedentary Behavior in Elderly People With Mild to Moderate Parkinson Disease. Phys Ther. 2015 Aug;95(8):1135-41. doi: 10.2522/ptj.20140374. Epub 2015 Feb 5.

Reference Type BACKGROUND
PMID: 25655884 (View on PubMed)

Pennington S, Snell K, Lee M, Walker R. The cause of death in idiopathic Parkinson's disease. Parkinsonism Relat Disord. 2010 Aug;16(7):434-7. doi: 10.1016/j.parkreldis.2010.04.010. Epub 2010 May 31.

Reference Type BACKGROUND
PMID: 20570207 (View on PubMed)

Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.

Reference Type BACKGROUND
PMID: 29228079 (View on PubMed)

Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.

Reference Type BACKGROUND
PMID: 24991037 (View on PubMed)

Ellis T, Boudreau JK, DeAngelis TR, Brown LE, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Barriers to exercise in people with Parkinson disease. Phys Ther. 2013 May;93(5):628-36. doi: 10.2522/ptj.20120279. Epub 2013 Jan 3.

Reference Type BACKGROUND
PMID: 23288910 (View on PubMed)

Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131.

Reference Type BACKGROUND
PMID: 30715489 (View on PubMed)

Other Identifiers

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PT-2021-025

Identifier Type: -

Identifier Source: org_study_id

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