NCT05737316

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

February 9, 2023

Last Update Submit

February 19, 2023

Conditions

Parkinson Disease

Keywords

exerciseGamification

Outcome Measures

Primary Outcomes (3)

  • Adherence to exercise program

    actual exercise frequency compared to prescribed exercise targets.

    12 weeks

  • Adherence to exercise program

    actual exercise duration compared to prescribed exercise targets.

    12 weeks

  • Adherence to exercise program

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

    12 weeks

Secondary Outcomes (10)

  • Adverse events

    12 weeks

  • Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)

    12 weeks

  • Timed Up and Go test (TUG)

    12 weeks

  • Dual-task Timed Up and Go Test (TUG)

    12 weeks

  • 6-minute walk test

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Combat PD

EXPERIMENTAL

Combat PD is an aerobic exercise programme hosted on a mobile application.

Behavioral: Combat PD

Usual Care

ACTIVE COMPARATOR

Home exercises based on a standard PD exercise booklet, consisting mainly of range of motion and stretching exercises

Behavioral: Usual Care

Interventions

Combat PDBEHAVIORAL

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.

Combat PD
Usual CareBEHAVIORAL

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.

Usual Care

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 30-75, diagnosed with Parkinson's disease, with mild disease severity (Hoehn and Yahr stages I to II)
  • Sedentary lifestyle
  • Has a smart phone device

You may not qualify if:

  • Uncontrolled hypertension, arrhythmia, or unstable cardiovascular status
  • Poorly controlled diabetes mellitus
  • Advanced kidney disease
  • BMI \> 30
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 569766, Singapore

RECRUITING

Related Publications (2)

  • 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.

    PMID: 22257506BACKGROUND

  • 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.

    PMID: 28607121BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Central Study Contacts

lauha Chung, PhD

CONTACT

+6563578305chloe_lh_chung@ttsh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patient blinding will be done by ensuring that patients are unaware of the content of either treatment group before participation, and will only be made aware of the content of their allocated programme after randomization. They will be instructed not to share the details of their exercise programme with their physicians or other study participants, and to only contact their assigned physiotherapist in case of any problems during the study. Intervention and control group participants will be assigned different dates for study site visits to avoid cross-contamination. Study team members who will assess outcomes or perform data analyses will be masked to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Physiotherapist

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

February 11, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

individual participant data that underlie the results reported, after deidentification

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
6 years after completion
Access Criteria
Researchers who provide a methodologically sound proposal

Locations

SG(1)