Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease

Study Overview
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Brief Summary
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Persons with Parkinson Disease (PD) face significant declines in function resulting in greater disability. Function can improve through participation in exercise, yet many people with PD are physically inactive. Given that people with PD live long lifespans following diagnosis; it is essential to include routine exercise into their lives over the long-term. Physical therapy is effective in improving function in persons with PD. However, participation in on-going physical therapy indefinitely is not a realistic option due to limited healthcare resources. Interventions using mobile health technologies allow physical therapists to stay connected to patients over time potentially improving their ability to meet the changing needs of patients with PD. Innovative approaches using mobile health technology may improve outcome; however, the effectiveness of different approaches to improve function and reduce disability in PD is unknown. The purpose of this study is to compare the effectiveness of two interventions to improve function and health-related quality of life in 65 people with PD. In one study group, participants receive a home exercise program, in written format, to continue on an independent basis. In the other study group, participants are instructed to continue with an exercise program, in their home, delivered using videos of the exercises on a computer tablet device. This use of mobile-Health technology allows the physical therapist to remotely monitor participants' progress and modify the exercise program to meet the changing needs of each patient. The long-term objective of this research is to determine the most efficient and effective way to improve function that can be widely disseminated to persons with PD.

Official Title
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Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Mobile Health Technology
* Behavioral: Stretching & Strengthening Exercises
* Behavioral: Walking with Pedometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inactive over the last 3 months Clinical diagnosis of idiopathic Parkinson's disease Mild to moderate disease severity Sufficient cognitive ability to follow study instructions Stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 12 month study period unless medically necessary Able to walk without physical assistance or an assistive device for at least 6 continuous minutes Be interested in participating and provide informed consent Exclusion Criteria: A diagnosis of atypical Parkinsonism Balance impairment (More than 2 falls in the previous month) Significant freezing Serious co-morbidities or medical conditions that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Health Technology<br>Stretching and strengthening exercises provided via video using mobile health technology; walk daily using a pedometer; interact with a physical therapist remotely through an exercise application on a tablet device over 12 month period | Behavioral: Mobile Health Technology<br> <br> Behavioral: Stretching & Strengthening Exercises<br> <br> Behavioral: Walking with Pedometer<br> <br> |
| Active Comparator: Control<br>Stretching and strengthening exercises provided using printed photographs; walk daily using a pedometer; interact with a physical therapist at the beginning of the 12 month study; no use of mobile technology | Behavioral: Stretching & Strengthening Exercises<br> <br> Behavioral: Walking with Pedometer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Physical Activity Level | Physical activity level will be assessed using an activity monitor worn around the ankle over a 7-day period at the beginning and the end of the study | 52-54 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in BriefBEST Balance Test | The BriefBEST balance test assesses balance using a series of tasks such as sitting and leaning, standing on compliant and non-compliant surfaces, stepping to the side, and walking on level surfaces | 52-54 weeks | 
| Change from Baseline in Six Minute Walk Test | Six Minute Walk Test is measure of the distance a participant is able to walk in a 6 minute time period | 52-54 weeks | 
| Change from Baseline in Falls Self-Efficacy Scale International | Falls Self-Efficacy Scale International is a self-administered questionnaire to assess the level of confidence in performing a series of 16 daily activities without falling | 52-54 weeks | 
| Change from Baseline in Unified Parkinson's Disease Rating Scale | Unified Parkinson's Disease Rating Scale assesses disability level related to the non-motor and motor signs in people with Parkinson's disease. | 52-54 weeks | 
| Change from Baseline in Parkinson's Disease Questionnaire-39 | Parkinson's Disease Questionnaire-39 is a self-administered questionnaire to assess the quality of life in people with Parkinson's disease | 52-54 weeks | 
| Change from Baseline in Self-Efficacy Exercise Scale | Self-Efficacy Exercise Scale is a self-administered questionnaire to assess confidence in ability to exercise | 52-54 weeks | 
| Change from Baseline in Functional Gait Assessment | Functional Gait Assessment assesses balance using a series of walking tasks, including walking in different directions, speeds, and around obstacles, including navigating stairs | 52-54 weeks | 
| Change from Baseline in Fatigue Severity Scale | Fatigue Severity Scale is a self-administered questionnaire where subjects are instructed to rate the impact of fatigue in their daily life over the prior week | 52-54 weeks | 
| Change from Baseline in Geriatric Depression Scale | Geriatric Depression Scale is a self-administered questionnaire to assess depression in individuals | 52-54 weeks | 
| Change from Baseline Apathy Scale | Apathy Scale is a self-administered questionnaire to assess apathy | 52-54 weeks | 
| Change from Baseline in Godin Leisure-Time Exercise Questionnaire | Godin Leisure-Time Exercise Questionnaire a self-administered questionnaire about the subjects leisure-time exercise habits over a typical seven day period | 52-54 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Rehabilitation, Telemedicine