Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology

Study Overview
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Brief Summary
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The purpose of this study is to test the feasibility of a novel motor-cognitive home training intervention using eHealth technology among people with Parkinson's Disease

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

Conditions
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Idiopathic Parkinson Disease, Telerehabilitation, Physical Therapy

Intervention / Treatment
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* Other: Motor-cognitive exercise therapy in the home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neurologist diagnosed Idiopathic PD at least 6 months previous to inclusion. Hoehn & Yahr stages I-III Stable in anti-Parkinson medications three months prior to inclusion. The ability to walk walk independently indoors without a walking aid. The ability to walk continually with/without a walking aid for at least 5 minutes. Exclusion Criteria: Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points). Impaired vision and/or impaired communication which hinders participation. 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 in the home. 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
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home training<br>Participants train 3 times weekly in their home environment with help of a digital training app, over a 10-week period. | Other: Motor-cognitive exercise therapy in the home<br>* Participants engage in a progressive 10-week exercise program targeted at improving motor and cognitive function. Motor exercises target functional strength, gait and physical activity level. Training sessions occur 3 times weekly and supported by a digital application which has been adapted for people with Parkinson's disease. Weeks 1-2 focus solely on motor exercises. Dual-task (Motor-cognitive) exercises are introduced at week 3 and progressed until week 10. Participants are also encouraged to increase the physical activity levels during the 10 week period. Weekly contact is made using the video function/ telephone with clinical specialists/ researchers. Two home visits will occur, the first one week prior to the intervention and at the 5-week period. Participants receive motivational messaging and reminders via the app during the intervention period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction with the eHealth intervention | Participants will rate their satisfaction with using a digital survey following each training session. An average value will be calculated. This will measure the feasibility outcome - Acceptability of the intervention. | 10-week period. | 
| Participants perceived intensity of the motor exercises | Participants will rate the intensity of the intervention using the Borg Rating of perceived, Exertion Scale (6-20) following each training session. According to this scale, lower numbers signify lower levels of exertion, and higher numbers signify higher levels of exertion. The aim is that participants levels of exertion will lie in the middle range (12-17) This will measure the feasibility outcome - Practicality or Ability to carry out the intervention. | 10-week period. | 
| Participants perceived difficulty of the motor-cognitive (dual-task) exercises | Participants will rate the difficulty of the dual-task exercises using a 0-10 scale (higher scores = higher degree of difficulty) following each exercise session and scores will be averaged over the study period following. This will measure the feasibility outcome - Suitability of the intervention. | 10-week period. | 
| Participants actual use of the eHealth training tool | Total time logged in to the digital training app will be derived from system and expressed as a percentage of total recommended intervention time. This will measure the feasibility outcome - Demand of the intervention'. | 10-week period. | 
| Total number of adverse events during the training sessions | Participants will report all adverse events such as falls or other injuries acquired during the training session, during a once weekly telephone interview. This will measure the feasibility outcome Safety. | 10 week period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Habitual physical activity | Measured by the ActiGraph accelerometer model GT3X+ (ActiGraph, Pensacola, FL, US) worn on the hip for seven consecutive days | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Usual and fast walking speed | 10 meter walk test at self-selected and fast speeds respectively | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Functional capacity as well as dual task gait ability | Assessed during the 2 minute walk test (2MWT) in single and dual task conditions | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Self-reported walk ability | Walk-12 G Questionnaire | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Lower extremity function | 30 second chair stand test | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Balance performance | Mini Balance Evaluation Systems Test (Mini-BESTest) | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Self-reported balance confidence | Activity-specific Balance Confidence (ABC) scale | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Self-reported difficulties across 8 dimensions of daily living | The Parkinson's Disease Questionnaire -39 (PDQ-39) | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Exercise self-efficacy | Swedish Exercise Self-Efficacy Scale (S-ESES) | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Executive Function | Attention and psychomotor processing speed will be assessed by the Trail making test (TMT) conditions 2 (letter Sequencing) and 4 (number-Letter Switching (set-shifting)) from Delis-Kaplan Executive Function System (D-KEFS). Results are presented as time in seconds. | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 
| Verbal Fluency | Verbal function, initiation & task-set switching will be assessed by the Verbal fluency (Letter Fluency, Category Fluency, and Category Switching) from Delis-Kaplan Executive Function System (D-KEFS). Raw scores are converted to scaled scores. | i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor-cognitive training, Home training