Clinical trial NCT05225506: Support + High Intensity Functional Training for Parkinson's
Official title: Support + High Intensity Functional Training for Parkinson's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: exercise
physical activity
parkinson
Lead sponsor: Arkansas Colleges of Health Education
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre and post test with assessments at baseline and after 3 and 6 months of intervention
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria for people with Parkinson's

* 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

Inclusion criteria for people who identify as care partners of those with Parkinson's

* 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

Exclusion Criteria:

-Failure to meet above listed inclusion criteria

Primary outcomes:
measure: Participant Attendance at 6 months
timeFrame: After 6 months of exercise intervention
Secondary outcomes:
measure: Change in lower extremity functional strength at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in grip strength at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in Activities Specific Balance Confidence (ABC) Scale at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in Mini Balance Evaluation Systems Test (Mini BESTest) at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in fast-paced gait speed at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in casual gait speed at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in Social Support for Exercise Scale at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in Self efficacy for exercise scale at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in 6 Minute Walk Test at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in Rand 36-Item Health Survey at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in Global Rating of Change at 6 Months
timeFrame: After 6 months of exercise intervention (T3)
measure: Change in Self-Reported Physical Activity Level at 6 Months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Change in accelerometer-measured moderate-to-vigorous physical activity at 6 months
timeFrame: Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3)
measure: Participant Retention
timeFrame: After 6 months of exercise intervention (T3)
measure: Participant Recruitment Rate
timeFrame: Throughout the 6-month study period
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Arkansas Colleges of Health Education
state: Arkansas
Study officials:
affiliation: Arkansas Colleges of Health Education
name: Reed Handlery, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.