A Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease

Study Overview
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Brief Summary
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This study aim to evaluate the (1) feasibility of a novel mobile application ( Combat PD) that support a home-based gamified aerobic exercise program in individuals with mild Parkinson's disease (PD). The study aims to further explore (2) the effectiveness of Combat PD in improving adherence to prescribed home-based exercise program; and (3) the clinical effectiveness if combat PD in improving motor and non-motor function in PD.

Detailed Description
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This study aim to evaluate the (1) feasibility of a novel mobile application ( Combat PD) that support a home-based gamified aerobic exercise program in individuals with mild Parkinson's disease (PD). The study aims to further explore (2) the effectiveness of Combat PD in improving adherence to prescribed home-based exercise program; and (3) the clinical effectiveness if combat PD in improving motor and non-motor function in PD.

Official Title
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A Randomised Controlled Feasibility Study of a Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Combat PD
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 30-75, diagnosed with Parkinson's disease, with mild disease severity (Hoehn and Yahr stages I to II) Sedentary lifestyle Receive a stable dose of dopaminergic medication for at least 4 weeks prior to study inclusion Has a smart phone device Exclusion Criteria: Uncontrolled hypertension, arrhythmia, or unstable cardiovascular status Poorly controlled diabetes mellitus Advanced kidney disease BMI > 30 Recent cerebrovascular event/ concussion/ fall in the last 6 months Significant cognitive impairment (MoCA<21) Any other medical/orthopaedic/psychiatric condition that would interfere with ability to participate in the study No stable internet or smart device access Inability to fill up self-reported questionnaires Attendance at any regular exercise programme up to 4 weeks prior to study inclusion

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combat PD<br>Combat PD is an aerobic exercise programme hosted on a mobile application. | Behavioral: Combat PD<br>* CombatPD is an aerobic exercise programme hosted on a mobile application that pairs with motion sensors and heart rate monitor, which connects to a web-based portal for remote monitoring. The wearable sensors consist of (i) 2 motion sensors worn across one thigh and attached to an exercise ring which is held by the participant during the exergame and (ii) 1 heart rate sensor worn across the participant's chest. They will receive once weekly physiotherapy sessions at the study site for the first 4 weeks where they will be guided through the use of the CombatPD. Participants will be instructed to perform 2 sessions of 30-minute exergames in addition to a session of 30-minute brisk walking every week for 12 weeks at home. They will be instructed to exercise at a target heart rate zone at moderate intensity (i.e., 40% - 60% Heart Rate Reserve), which will be gradually increased.<br>|
| Active Comparator: Usual Care<br>Home exercises based on a standard PD exercise booklet, consisting mainly of range of motion and stretching exercises | Behavioral: Usual Care<br>* Participants in the control group (usual care) will receive once weekly physiotherapy sessions for first 2 weeks and another session at week 6 where they will be taught home exercises based on a standard PD exercise booklet, consisting mainly of range of motion and stretching exercises , as well as brisk walking techniques. Participants in the control group will be instructed to perform these home exercises twice a week, in addition to a 30-minute brisk walk for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to exercise program | actual exercise frequency compared to prescribed exercise targets. | 12 weeks | 
| Adherence to exercise program | actual exercise duration compared to prescribed exercise targets. | 12 weeks | 
| Adherence to exercise program | actual exercise intensity (period of exercise performed within prescribed heart rate zone), compared to prescribed exercise targets. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue. | 12 weeks | 
| Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III) | Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III) is a valid and reliable clinical test to evaluate the severity of motor symptoms of PD, score range 0-132, 32 and below is mild, 59 and above is severe. | 12 weeks | 
| Timed Up and Go test (TUG) | The TUG test measures the time in seconds taken by participants to perform sequential locomotor tasks that incorporate walking and turning. | 12 weeks | 
| Dual-task Timed Up and Go Test (TUG) | Participants were instructed to repeat the TUG procedure while performing a serial three subtraction. | 12 weeks | 
| 6-minute walk test | The maximal distance covered over a time of 6 minute. | 12 weeks | 
| Montreal Cognitive Assessment (MoCA) | MoCA is a widely used screening assessment for detecting cognitive impairment, The basics of this test include short-term memory, executable performance, attention, focus and more. Score range 0-30. A score of 26 or over is considered to be normal. | 12 weeks | 
| Hospital Anxiety and Depression Scale (HADS) | A reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from 0 to 3, with 3 denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. | 12 weeks | 
| Fatigue Severity Scale (FSS) | The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Score range from 9-63, higher the score denotes greater fatigue severity. | 12 weeks | 
| Scales for Outcomes in Parkinson's disease (SCOPA-sleep) | SCOPA-sleep is a reliable and valid patient-completed instrument for assessing nighttime sleep (5 items, 0-4) and daytime sleepiness (6 items 0-4) in patients with PD. with two additional questions on use of sleeping tablet ( 0-4) and Global evaluation of sleeping at night (0-7), sum up to total score of 55, higher score denotes worst sleeping performance. | 12 weeks | 
| Parkinson Disease Questionnaire (PDQ)-8 | It's a self-administered questionnaire, used to measure quality of life in persons with PD. It is an eight-question instrument and each score is scored between 0 and 4. Total score sum up to 32, a higher score signifies poorer quality of life. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, Gamification