Support + High Intensity Functional Training for Parkinson's

NCT05225506 | Completed

• 1 other identifier: PT-2021-025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

exercise; physical activity; parkinson

Outcome Measures

Primary Outcomes (1)

• Participant Attendance at 6 months

  The percentage of interventions sessions attended by participants.

  After 6 months of exercise intervention

Secondary Outcomes (17)

• Change in lower extremity functional strength at 6 months

  Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)

• Change in grip strength at 6 months

  Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)

• Change in Activities Specific Balance Confidence (ABC) Scale at 6 months

  Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)

• Change in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 6 months

  Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)

• Change in Mini Balance Evaluation Systems Test (Mini BESTest) at 6 months

  Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)

Study Arms (1)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Interventions

Exercise 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.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Arkansas Colleges of Health Education: lead

Study Sites (1)

Arkansas Colleges of Health Education

Fort Smith, Arkansas, 72916, United States

Location

Related Publications (6)

• 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.

  PMID: 25655884 BACKGROUND

• 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.

  PMID: 20570207 BACKGROUND

• 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.

  PMID: 29228079 BACKGROUND

• 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.

  PMID: 24991037 BACKGROUND

• 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.

  PMID: 23288910 BACKGROUND

• 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.

  PMID: 30715489 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Reed Handlery, PhD

  Arkansas Colleges of Health Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pre and post test with assessments at baseline and after 3 and 6 months of intervention

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 4, 2022
• Study Start: February 21, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)