Support + High Intensity Functional Training for Parkinson's

Study Overview
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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.

Official Title
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Support + High Intensity Functional Training for Parkinson's

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre and post test with assessments at baseline and after 3 and 6 months of intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>In this single group design, all participants will be provided with 6 months of twice weekly supervised group exercise. | Behavioral: Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Attendance at 6 months | The percentage of interventions sessions attended by participants. | After 6 months of exercise intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lower extremity functional strength at 6 months | Lower extremity strength will be measured via functional test (Five Times Sit to Stand). This test records the amount of time taken to rise and sit to and from a chair five consecutive times. Faster times indicate greater lower extremity strength. | 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 | Grip strength will be measured via hand held dynamometry. Participants will perform three trials using their dominant hand. The force of each grip will be recorded and averaged in pounds. | 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 | The ABC scale is a 16-item participant-reported measure of balance confidence while performing various activities. Participants rank their level of confidence from 0 (not at all confident) to 100 (completely confident); scores from each item are then averaged for one final score. The maximum score is 100%, indicating high balance confidence. | 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 | The PDQ-39 is a 39-item participant-reported questionnaire which assesses health-related quality of life across 8 domains (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort). Participants respond to each item using a 5-point Likert scale from 0 (never) to 4 (always). Items in each domain are scored by expressing summed item scores as a percentage (ranging from 0 to 100%). Lower scores indicate better quality of life. | 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 | The Mini BESTest is a 14-item test that assesses Anticipatory balance, reactive postural control, sensory orientation and dynamic gait. Performance for each item is ranked on a 3-point ordinal scale (0,1, or 2) with a total possible score of 28 (indicating good balance). | 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 | Fast-paced walking speed will be measured via 10 meter walk test, which has individuals walk 10 meters with the middle 6 meters timed; three trial are performed and the average time is taken. Faster walking speeds indicate greater mobility with walking. | Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3) | 
| Change in casual gait speed at 6 months | Walking speed will be measured via 10 meter walk test, which has individuals walk 10 meters with the middle 6 meters timed; three trial are performed and the average time is taken. Faster walking speeds indicate greater mobility with walking. | 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 | The Social Support for Exercise Scale contains 13 items and asks participants to rank frequency of supporting exercise behaviors amongst both family and friends on a 5-point Likert scale (1, none to 5, very often). Scores range from 13 to 65 with higher scores indicating greater social support for exercise. | 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 | The Self-Efficacy for Exercise Scale contains 9 items and asks participants to rank their confidence (0, not confident to 10, very confident) in their ability to exercise three times per week for 20 minutes in 9 different scenarios. Scores range from 0 to 90 with higher scores indicating greater exercise self-efficacy. | 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 | The 6 Minute Walk Test measures a participants ability to cover as much distance (measured in meters) as possible while walking for 6 minutes. Participants will walk along a pre-defined pathway for 6 minutes, resting as needed. The test is a measure of walking endurance with further distances indicating greater endurance. | 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 | Health related quality of life will be measured via Rand 36-item Health Survey. This 36 item survey asks participants about their health in several categories (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health). Scores in each category are averaged and range from 0 to 100, with higher scores indicating better health-related quality of life. | 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 | The MDS-UPDRS measures disability as a result of Parkinson's and allows tracking for progression of the disease. The scale has four parts (1, mentation, behavior and mood, 2, activities of daily living, 3, motor examination, and 4, complications of therapy. Each parkinsonian sign or symptom is ranked on a 5-point Likert scale (ranging from 0 to 4) with higher scores indicating greater impairments. The minimum score on the entire scale is 0 and the maximum is 199. | 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 | Participants will rate their perceived level of change on a 15-point Likert Scale ranging from -7 (a very great deal less/worse to +7 (a very great deal more/better) with 0 representing no change. They will use this scale to answer 6 separate questions: 1) amount of physical activity performed in an average week, 2) ability to walk leisurely, 3) ability to walk fast, 4) ability to walk for a long period of time, 5) ability to stand up from a seated position, 6) ability to steady yourself and prevent a fall. | After 6 months of exercise intervention (T3) | 
| Change in Self-Reported Physical Activity Level at 6 Months | Participants report their perceived physical activity levels compared to people their own age using a 5-point Likert Scale ranging from much more active to much less active. | 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 | Physical activity levels will be measured via thigh-worn accelerometer (activPAL). This small device will be worn on the less affected thigh (or right thigh for care partners) of participants with Parkinson's. The activPAL is able to detect acceleration and body position (i.e. sitting, standing, or lying). Through collecting acceleration data, different intensities of physical activity will be inferred (i.e light, moderate and vigorous intensity physical activity), with moderate-to-vigorous intensity physical activity being used as the primary outcome measure. At all time points, participants will wear the activPAL for 7 consecutive days. The activPAL will be waterproofed and will not need to be removed for activities such as bathing. | Prior to exercise intervention (T1), after 3 months of intervention (T2), and after 6 months of exercise intervention (T3) | 
| Participant Retention | The number and percentage of participants who remain in the study through the final measurement point at 6 months. | After 6 months of exercise intervention (T3) | 
| Participant Recruitment Rate | The number of participants recruited will be reported as a percentage of total participants contacted for study participation. | Throughout the 6-month study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, physical activity, parkinson