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Clinical Trials/NCT05737316
NCT05737316
Recruiting
Not Applicable

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

Tan Tock Seng Hospital1 site in 1 country60 target enrollmentFebruary 11, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Tan Tock Seng Hospital
Enrollment
60
Locations
1
Primary Endpoint
Adherence to exercise program
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 11, 2023
End Date
June 30, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tan Tock Seng Hospital
Responsible Party
Principal Investigator
Principal Investigator

Chloe Chung Lau Ha

Principal Physiotherapist

Tan Tock Seng Hospital

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Adherence to exercise program

Time Frame: 12 weeks

actual exercise intensity (period of exercise performed within prescribed heart rate zone), compared to prescribed exercise targets.

Secondary Outcomes

  • Dual-task Timed Up and Go Test (TUG)(12 weeks)
  • Montreal Cognitive Assessment (MoCA)(12 weeks)
  • Scales for Outcomes in Parkinson's disease (SCOPA-sleep)(12 weeks)
  • Timed Up and Go test (TUG)(12 weeks)
  • Adverse events(12 weeks)
  • Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)(12 weeks)
  • 6-minute walk test(12 weeks)
  • Fatigue Severity Scale (FSS)(12 weeks)
  • Parkinson Disease Questionnaire (PDQ)-8(12 weeks)
  • Hospital Anxiety and Depression Scale (HADS)(12 weeks)

Study Sites (1)

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