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

February 19, 2023 updated by: Chloe Chung Lau Ha, Tan Tock Seng Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 569766
        • Recruiting
        • Tan Tock Seng Hospital
        • Contact:
        • Principal Investigator:
          • Xiumin Shermyn Neo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combat PD
Combat PD is an aerobic exercise programme hosted on a mobile application.
Behavioral: Combat 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.
Active Comparator: Usual Care
Home exercises based on a standard PD exercise booklet, consisting mainly of range of motion and stretching exercises
Behavioral: Usual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to exercise program
Time Frame: 12 weeks
actual exercise frequency compared to prescribed exercise targets.
12 weeks
Adherence to exercise program
Time Frame: 12 weeks
actual exercise duration compared to prescribed exercise targets.
12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 12 weeks
Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue.
12 weeks
Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)
Time Frame: 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.
12 weeks
Timed Up and Go test (TUG)
Time Frame: 12 weeks
The TUG test measures the time in seconds taken by participants to perform sequential locomotor tasks that incorporate walking and turning.
12 weeks
Dual-task Timed Up and Go Test (TUG)
Time Frame: 12 weeks
Participants were instructed to repeat the TUG procedure while performing a serial three subtraction.
12 weeks
6-minute walk test
Time Frame: 12 weeks
The maximal distance covered over a time of 6 minute.
12 weeks
Montreal Cognitive Assessment (MoCA)
Time Frame: 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.
12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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.
12 weeks
Fatigue Severity Scale (FSS)
Time Frame: 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.
12 weeks
Scales for Outcomes in Parkinson's disease (SCOPA-sleep)
Time Frame: 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.
12 weeks
Parkinson Disease Questionnaire (PDQ)-8
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Collaborators

Singhealth Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 11, 2023

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

February 19, 2023

First Posted (Estimate)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/00768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

individual participant data that underlie the results reported, after deidentification

IPD Sharing Time Frame

6 years after completion

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Combat PD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe