Clinical trial NCT05737316: A Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease
Official title: A Randomised Controlled Feasibility Study of a Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: exercise
Gamification
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Singhealth Foundation
First posted: 2023-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to exercise program
timeFrame: 12 weeks
measure: Adherence to exercise program
timeFrame: 12 weeks
measure: Adherence to exercise program
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 12 weeks
measure: Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)
timeFrame: 12 weeks
measure: Timed Up and Go test (TUG)
timeFrame: 12 weeks
measure: Dual-task Timed Up and Go Test (TUG)
timeFrame: 12 weeks
measure: 6-minute walk test
timeFrame: 12 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 12 weeks
measure: Scales for Outcomes in Parkinson's disease (SCOPA-sleep)
timeFrame: 12 weeks
measure: Parkinson Disease Questionnaire (PDQ)-8
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
References:
citation: 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.
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.