Support for Physical Activity in Everyday Life With Parkinson's Disease

Study Overview
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Brief Summary
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This study aims to determine the effects of a motor-cognitive exercise intervention, delivered in the home environment using eHealth methods, among people with Parkinson's disease. The intervention will support and motivate motor training, combined with cognitive training, aimed at attentional and executive functions, among people at mild-moderate disease stages. The main hypothesis is that unsupervised motor-cognitive training in the home environment using eHealth will lead to improvements in gait performance, increased physical activity levels and improved perceived health.

Detailed Description
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This randomised controlled trial will investigate the efficacy of a motor-cognitive exercise program in the home environment, over a 10-week period, on physical function, and motor-cognitive dual task function as well as physical activity behavior in everyday life. Participants will be recruited through Stockholms sjukhem foundation, Karolinska University and via announcements in relevant forums like for instance the Swedish Parkinson Association. Consenting participants will be randomized to the eHealth Intervention group or the control group condition. Block randomization will be achieved using a computerized random sequence generator. Blinded assessors will perform the pre- and post-intervention testing of physical performance. The ultimate aim of this project is to provide people with PD with continual long-term and evidence-based rehabilitation in their everyday lives using mobile health technology, to support their self- management and increase their quality of life.

Official Title
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Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology

Conditions
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Parkinson Disease, Physical Activity, eHealth, Gait Disorders, Neurologic

Intervention / Treatment
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* Behavioral: Motor-cognitive home exercise supported by eHealth technology
* Behavioral: Individualized home exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic Parkinson´s disease Hoehn & Yahr (Parkinsons progression scale) 2-3 ≥ 50 years of age Able to ambulate indoors without mobility aid Able to walk continually with/without a walking aid for at least 6 minutes Exclusion Criteria: Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points Major problems with freezing and/or two or more falls in the month previous to inclusion Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise Impaired vision and/or impaired communication which hinders participation No internet connection in the home

Ages Eligible for Study
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Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor-cognitive exercise using eHealth<br>10-week eHealth based motor-cognitive home training using digital tablets. Cognitive behavioural strategies to promote increase in physical activity levels (walking). Participants will be encouraged to perform 150 minutes of home exercise per week, occurring on three non-consecutive days. | Behavioral: Motor-cognitive home exercise supported by eHealth technology<br>* 10-week, individualized and progressive exercise program targeting functional strength, cardiovascular fitness and physical activity levels. Cognitive exercises are incorporated with motor exercises as an adjunct to the intervention.<br>|
| Active Comparator: Individualised home training program<br>Participants will receive an individualized home exercise program on paper and one instructional session. They will receive written instructions on performing the program 2-3 times weekly and instructions on exercise progression. They will receive no support during the 10-week period. | Behavioral: Individualized home exercise program<br>* Individualised home exercise program leaflet involving one initial instruction session. Written instructions involving dose and exercise progression. No support during the 10 week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The six minute walk test | This test measures walking capacity by measuring the distance covered (meters) over a time period of 6 minutes. | Change in balance performance at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait parameters during single and dual-task conditions | Stride length (meters); Cadence (steps/ minute) will be captured using born-worn inertial sensors | Change at 10 weeks | 
| Quality of life questionnaires | PDQ-39 is disease specific quality of life questionnaire. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 | Change at 10 weeks | 
| Physical activity measured with accelerometers | Steps per day and time (minutes) in different physical activity intensities (high,moderate and low intensity) | Change at 10 weeks | 
| Dual-task ability during walking | Captured using the Auditory Stroop test during walking and expressed as percentage error of the task | Change at 10 weeks | 
| Balance ability | MiniBest test. Scoring 0-27, higher scores = greater balance impairment | Change at 10 weeks | 
| Executive function | Trail making test A & B. Expressed as time required to perform the test (seconds) | Change at 10 weeks |