Parkinson Disease
Conditions
Keywords
exercise, Gamification
Brief summary
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
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.
Interventions
BEHAVIORALCombat PD
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.
BEHAVIORALUsual Care
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.
Sponsors
Singhealth Foundation
Tan Tock Seng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patient blinding will be done by ensuring that patients are unaware of the content of either treatment group before participation, and will only be made aware of the content of their allocated programme after randomization. They will be instructed not to share the details of their exercise programme with their physicians or other study participants, and to only contact their assigned physiotherapist in case of any problems during the study. Intervention and control group participants will be assigned different dates for study site visits to avoid cross-contamination. Study team members who will assess outcomes or perform data analyses will be masked to group allocation.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 30-75, diagnosed with Parkinson's disease, with mild disease severity (Hoehn and Yahr stages I to II) 2. Sedentary lifestyle 3. Receive a stable dose of dopaminergic medication for at least 4 weeks prior to study inclusion 4. Has a smart phone device
Exclusion criteria
1. Uncontrolled hypertension, arrhythmia, or unstable cardiovascular status 2. Poorly controlled diabetes mellitus 3. Advanced kidney disease 4. BMI \> 30 5. Recent cerebrovascular event/ concussion/ fall in the last 6 months 6. Significant cognitive impairment (MoCA\<21) 7. Any other medical/orthopaedic/psychiatric condition that would interfere with ability to participate in the study 8. No stable internet or smart device access 9. Inability to fill up self-reported questionnaires 10. Attendance at any regular exercise programme up to 4 weeks prior to study inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to exercise program | 12 weeks | actual exercise frequency compared to prescribed exercise targets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III) | 12 weeks | 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. |
| Timed Up and Go test (TUG) | 12 weeks | The TUG test measures the time in seconds taken by participants to perform sequential locomotor tasks that incorporate walking and turning. |
| Dual-task Timed Up and Go Test (TUG) | 12 weeks | Participants were instructed to repeat the TUG procedure while performing a serial three subtraction. |
| 6-minute walk test | 12 weeks | The maximal distance covered over a time of 6 minute. |
| Adverse events | 12 weeks | Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue. |
| Hospital Anxiety and Depression Scale (HADS) | 12 weeks | 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. |
| Fatigue Severity Scale (FSS) | 12 weeks | 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. |
| Scales for Outcomes in Parkinson's disease (SCOPA-sleep) | 12 weeks | 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. |
| Parkinson Disease Questionnaire (PDQ)-8 | 12 weeks | 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. |
| Montreal Cognitive Assessment (MoCA) | 12 weeks | 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. |
Countries
Singapore
Contacts
Primary Contactlauha Chung, PhD
Outcome results
None listed