Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 5:43 PM
Study NCT ID:
NCT05225506
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2022-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Support + High Intensity Functional Training for Parkinson's
Sponsor:
Arkansas Colleges of Health Education
Organization:
Study Overview
Official Title:
Support + High Intensity Functional Training for Parkinson's
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIFT-PD
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: