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Clinical Trials/NCT05225506
NCT05225506
Completed
Not Applicable

Support + High Intensity Functional Training for Parkinson's

Arkansas Colleges of Health Education1 site in 1 country25 target enrollmentFebruary 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Arkansas Colleges of Health Education
Enrollment
25
Locations
1
Primary Endpoint
Participant Attendance at 6 months
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2022
End Date
November 24, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reed Handlery

Assistant Professor

Arkansas Colleges of Health Education

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Failure to meet above listed inclusion criteria

Outcomes

Primary Outcomes

Participant Attendance at 6 months

Time Frame: After 6 months of exercise intervention

The percentage of interventions sessions attended by participants.

Secondary Outcomes

  • 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))
  • 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 fast-paced gait speed at 6 months(Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3))
  • Change in Movement Disorder Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at 6 months(Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3))
  • Change in Global Rating of Change at 6 Months(After 6 months of exercise intervention (T3))
  • Participant Recruitment Rate(Throughout the 6-month study period)
  • Change in casual gait speed at 6 months(Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3))
  • Change in Social Support for Exercise 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 Self efficacy for exercise 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 6 Minute Walk Test at 6 months(Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3))
  • Change in Rand 36-Item Health Survey at 6 months(Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3))
  • Change in Self-Reported Physical Activity Level at 6 Months(Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3))
  • Change in accelerometer-measured moderate-to-vigorous physical activity at 6 months(Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3))
  • Participant Retention(After 6 months of exercise intervention (T3))

Study Sites (1)

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