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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Combat PD
Usual Care
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring exercise, Gamification

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 Attendance at any regular exercise programme up to 4 weeks prior to study inclusion

Sites / Locations

  • Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combat PD

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events
Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue.
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.
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.
Dual-task Timed Up and Go Test (TUG)
Participants were instructed to repeat the TUG procedure while performing a serial three subtraction.
6-minute walk test
The maximal distance covered over a time of 6 minute.
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.
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.
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.
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.
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.

Full Information

First Posted
February 9, 2023
Last Updated
February 19, 2023
Sponsor
Tan Tock Seng Hospital
Collaborators
Singhealth Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05737316
Brief Title
A Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease
Official Title
A Randomised Controlled Feasibility Study of a Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Singhealth Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
exercise, Gamification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combat PD
Arm Type
Experimental
Arm Description
Combat PD is an aerobic exercise programme hosted on a mobile application.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Home exercises based on a standard PD exercise booklet, consisting mainly of range of motion and stretching exercises
Intervention Type
Behavioral
Intervention Name(s)
Combat PD
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to exercise program
Description
actual exercise frequency compared to prescribed exercise targets.
Time Frame
12 weeks
Title
Adherence to exercise program
Description
actual exercise duration compared to prescribed exercise targets.
Time Frame
12 weeks
Title
Adherence to exercise program
Description
actual exercise intensity (period of exercise performed within prescribed heart rate zone), compared to prescribed exercise targets.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue.
Time Frame
12 weeks
Title
Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)
Description
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.
Time Frame
12 weeks
Title
Timed Up and Go test (TUG)
Description
The TUG test measures the time in seconds taken by participants to perform sequential locomotor tasks that incorporate walking and turning.
Time Frame
12 weeks
Title
Dual-task Timed Up and Go Test (TUG)
Description
Participants were instructed to repeat the TUG procedure while performing a serial three subtraction.
Time Frame
12 weeks
Title
6-minute walk test
Description
The maximal distance covered over a time of 6 minute.
Time Frame
12 weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
12 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
12 weeks
Title
Fatigue Severity Scale (FSS)
Description
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.
Time Frame
12 weeks
Title
Scales for Outcomes in Parkinson's disease (SCOPA-sleep)
Description
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.
Time Frame
12 weeks
Title
Parkinson Disease Questionnaire (PDQ)-8
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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 Attendance at any regular exercise programme up to 4 weeks prior to study inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lauha Chung, PhD
Phone
+6563578305
Email
chloe_lh_chung@ttsh.com.sg
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
569766
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Lauha Chung, PhD
Phone
6357 8305
Email
Chloe_lh_chung@ttsh.com.sg
First Name & Middle Initial & Last Name & Degree
Xiumin Shermyn Neo

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
22257506
Citation
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.
Results Reference
background
PubMed Identifier
28607121
Citation
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.
Results Reference
background

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

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