Parkinson DiseaseNCT05737316
A Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease
A study testing Combat PD in people with Parkinson Disease, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Combat PD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Feb 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 569766
Chloe Lauha Chung, PhD, 6357 8305, Chloe_lh_chung@ttsh.com.sg
Xiumin Shermyn Neo
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Combat PD, Usual Care
- Keywords
- exercise, Gamification
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combat PDBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Combat PD | Experimental | Combat PD is an aerobic exercise programme hosted on a mobile application. Receives: 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 Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to exercise program
actual exercise frequency compared to prescribed exercise targets.
Measured: 12 weeks
Adherence to exercise program
actual exercise duration compared to prescribed exercise targets.
Measured: 12 weeks
Adherence to exercise program
actual exercise intensity (period of exercise performed within prescribed heart rate zone), compared to prescribed exercise targets.
Measured: 12 weeks
Secondary outcomes (10)
Adverse events
Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue.
Measured: 12 weeks
Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)
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.
Measured: 12 weeks
Timed Up and Go test (TUG)
The TUG test measures the time in seconds taken by participants to perform sequential locomotor tasks that incorporate walking and turning.
Measured: 12 weeks
Dual-task Timed Up and Go Test (TUG)
Participants were instructed to repeat the TUG procedure while performing a serial three subtraction.
Measured: 12 weeks
6-minute walk test
The maximal distance covered over a time of 6 minute.
Measured: 12 weeks
Montreal Cognitive Assessment (MoCA)
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.
Measured: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: 12 weeks
Fatigue Severity Scale (FSS)
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.
Measured: 12 weeks
Scales for Outcomes in Parkinson's disease (SCOPA-sleep)
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.
Measured: 12 weeks
Parkinson Disease Questionnaire (PDQ)-8
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start11 Feb 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singhealth Foundation
- Responsible party
- Principal investigator, Chloe Chung Lau Ha, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737316
- Sponsor's protocol ID
- 2021/00768
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data that underlie the results reported, after deidentification
Publications
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.
PubMed 22257506van 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.
PubMed 28607121
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Feasibility Study of a Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05737316
- Acronym / sponsor ID
- 2021/00768
- Conditions
- Parkinson Disease
- Keywords
- exercise, Gamification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Singhealth Foundation
- Study start
- 11 Feb 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combat PD | Experimental | Behavioral: Combat PDCombat PD is an aerobic exercise programme hosted on a mobile application. |
| Usual Care | Active comparator | Behavioral: Usual CareHome exercises based on a standard PD exercise booklet, consisting mainly of range of motion and stretching exercises |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combat PDCombatPD 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. | Behavioural | Combat PD |
| Usual CareParticipants 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. | Behavioural | Usual Care |
Primary outcome
Adherence to exercise program
Time frame: 12 weeks
actual exercise frequency compared to prescribed exercise targets.
Adherence to exercise program
Time frame: 12 weeks
actual exercise duration compared to prescribed exercise targets.
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.
10 secondary outcomes
Adverse events
Time frame: 12 weeks
Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)
Time frame: 12 weeks
Timed Up and Go test (TUG)
Time frame: 12 weeks
Dual-task Timed Up and Go Test (TUG)
Time frame: 12 weeks
6-minute walk test
Time frame: 12 weeks
Montreal Cognitive Assessment (MoCA)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Fatigue Severity Scale (FSS)
Time frame: 12 weeks
Scales for Outcomes in Parkinson's disease (SCOPA-sleep)
Time frame: 12 weeks
Parkinson Disease Questionnaire (PDQ)-8
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 22257506Canning 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.
- Background: PubMed 28607121van 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.
- Individual participant dataSharing planned: Yes. individual participant data that underlie the results reported, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combat PD in people with Parkinson Disease, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lauha Chung, PhD (+6563578305, chloe_lh_chung@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to exercise program (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05737316, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.