Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease

Study Overview
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Brief Summary
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This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. The impact of participation in this program on motor function, postural control, gait, quality of life, and self-efficacy for exercise will be measured.

Detailed Description
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This program will be delivered 2 times per week for 8 weeks with examination of outcome measures prior to and after completion. The investigators plan to enroll 20 participants with 10 completing a group program led by a physical therapist and 10 completing an individual exercise program led by a physical therapist.

Official Title
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Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Multidimensional Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a diagnosis of idiopathic Parkinson disease been prescribed a stable dose of levadopa medication for at least 4 weeks prior to study participation be able to walk independently have a referral from a physician to participate in the program have access to a computer/tablet/or phone to use for telehealth sessions with reliable internet and access to the Zoom platform Exclusion Criteria: have any other neurological condition other than Parkinson disease have a score less than 20/28 on the Mini-Balance Systems Evaluation Test (reflecting a higher risk of falls) demonstrate unstable/unsafe blood pressure or heart rate responses during the initial evaluation with response to submaximal exercise have any musculoskeletal condition that affected their ability to participate in the exercise group score less than 24/30 on the Mini Mental Status Examination during the initial evaluation

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to either exercise individually with a physical therapist or in a group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individual Exercise Instruction<br>The participant will receive individual exercise instruction. | Other: Multidimensional Exercise Program<br>* The multidirectional exercise program will include cardiovascular training, strengthening, balance training, and flexibility training. This will be delivered 2 times per week for 8 weeks using telehealth and will be delivered by a physical therapist. The exercises will be modified to meet the participants needs. Intensity of exercise interventions will be monitored through patient self report and use of continuous heart rate monitoring.<br>|
| Experimental: Group Exercise Instruction<br>The participant will receive the instruction in a group of up to 9 other participants. | Other: Multidimensional Exercise Program<br>* The multidirectional exercise program will include cardiovascular training, strengthening, balance training, and flexibility training. This will be delivered 2 times per week for 8 weeks using telehealth and will be delivered by a physical therapist. The exercises will be modified to meet the participants needs. Intensity of exercise interventions will be monitored through patient self report and use of continuous heart rate monitoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mini-Balance Evaluation Systems Test Score | This is a 14 item outcome measure that examines postural control in standing. The measure includes items that assess anticipatory postural control, reactive postural control, somatosensory integration, and dynamic gait. The scores range from 0-28 points with 28 reflecting the best possible balance performance. | Prior to and after the 8 week intervention. | 
| Change in Five Times Sit to Stand test time | For this outcome the participant is asked to perform sitting to standing transitions 5 times as quickly as possible. The time to complete the task is recorded. A lower time is associated with faster and more agile performance with sitting to standing transitions. | Prior to and after the 8 week intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10 meter walk test | This outcome measure examines gait speed at comfortable and fast speeds. This will be performed using the Gait Rite mat which will collect information about gait characteristics, including step length, step width, and gait symmetry as well. A faster time is associated with better balance and walking ability. | Prior to and after 8 week intervention. | 
| Change in Six Minute Walk Test Distance | This outcome examines gait endurance by measuring the distance walked over 6 minutes on a level surface. A greater number of meters on the test is associated with better walking endurance. | Prior to and after 8 week intervention. | 
| Change in Parkinson Disease Questionnaire-39 score | This is a self report quality of life measure designed for individuals with Parkinson disease. There are 8 subsections which can be reported individually and the score can be calculated as a summary score out of 100%. A lower percentage is associated with lower disability related to Parkinson disease. | Prior to and after 8 week intervention. | 
| Change in Self Efficacy for Exercise Scale score | This measures a person's confidence that they will exercise in a variety of situations.The score ranges from 0 to 90 with a higher score associated with a higher self efficacy for exercise behavior. | Prior to and after 8 week intervention. |