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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Behavioral: Combat PD; Behavioral: Usual Care

• Registration Number: NCT05737316
• Lead Sponsor: Tan Tock Seng Hospital

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study Start: 2023-02-11
• Study First Submitted QC: 2023-02-19
• Last Update Submitted: 2023-02-19
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combat PD	Combat PD	Combat PD is an aerobic exercise programme hosted on a mobile application.
Usual Care	Usual Care	Home exercises based on a standard PD exercise booklet, consisting mainly of range of motion and stretching exercises

Primary Outcome Measures

Name	Time	Method
Adherence to exercise program	12 weeks	actual exercise intensity (period of exercise performed within prescribed heart rate zone), compared to prescribed exercise targets.

Secondary Outcome Measures

Name	Time	Method
Dual-task Timed Up and Go Test (TUG)	12 weeks	Participants were instructed to repeat the TUG procedure while performing a serial three subtraction.
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.
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.
Adverse events	12 weeks	Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue.
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.
6-minute walk test	12 weeks	The maximal distance covered over a time of 6 minute.
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.
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.
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.

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore