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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-11

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exercise Study For People With Parkinson's Disease

NCT00387218

Parkinson's Disease

UNKNOWN NA

Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology

NCT05027620

Idiopathic Parkinson Disease Telerehabilitation Physical Therapy

COMPLETED NA

Support for Physical Activity in Everyday Life With Parkinson's Disease

NCT05510739

Parkinson Disease Physical Activity eHealth +1 more

ACTIVE_NOT_RECRUITING NA

Assessing the Role of Exercise Intensity in Slowing Disease Progression in Early Parkinson's Disease

NCT00385073

Parkinson's Disease

UNKNOWN

Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease

NCT04046276

Parkinson's Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Combat PD

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

Group Type EXPERIMENTAL

Combat PD

Intervention Type BEHAVIORAL

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.

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No