Parkinson Disease Clinical Trial
Official title:
A Randomised Controlled Feasibility Study of a Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital | Singhealth Foundation |
Singapore,
Canning CG, Allen NE, Dean CM, Goh L, Fung VS. Home-based treadmill training for individuals with Parkinson's disease: a randomized controlled pilot trial. Clin Rehabil. 2012 Sep;26(9):817-26. doi: 10.1177/0269215511432652. Epub 2012 Jan 18. — View Citation
van der Kolk NM, de Vries NM, Penko AL, van der Vlugt M, Mulder AA, Post B, Alberts JL, Bloem BR. A remotely supervised home-based aerobic exercise programme is feasible for patients with Parkinson's disease: results of a small randomised feasibility trial. J Neurol Neurosurg Psychiatry. 2018 Sep;89(9):1003-1005. doi: 10.1136/jnnp-2017-315728. Epub 2017 Jun 12. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to exercise program | actual exercise frequency compared to prescribed exercise targets. | 12 weeks | |
Primary | Adherence to exercise program | actual exercise duration compared to prescribed exercise targets. | 12 weeks | |
Primary | Adherence to exercise program | actual exercise intensity (period of exercise performed within prescribed heart rate zone), compared to prescribed exercise targets. | 12 weeks | |
Secondary | Adverse events | Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue. | 12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Dual-task Timed Up and Go Test (TUG) | Participants were instructed to repeat the TUG procedure while performing a serial three subtraction. | 12 weeks | |
Secondary | 6-minute walk test | The maximal distance covered over a time of 6 minute. | 12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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