UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054292 |
|---|---|
| Receipt number | R000062010 |
| Scientific Title | Feasibility, acceptability, safety, and potential effectiveness of an exergame program for patients with advanced Parkinson's disease: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2025/08/29 15:19:51 |
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Basic information
Public title
A study to determine whether a universally designed exergame is safe,acceptable,and helpful for people with advanced Parkinson's disease living in care facilities
Acronym
Exergame in advanced PD
Scientific Title
Feasibility, acceptability, safety, and potential effectiveness of an exergame program for patients with advanced Parkinson's disease: a pilot randomized controlled trial
Scientific Title:Acronym
Exergame-Advanced PD Pilot RCT
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to introduce a universally designed exergame program for patients with advanced Parkinson's disease and to examine its feasibility (acceptability, safety, and adherence), as well as to exploratorily evaluate its potential effects on health-related quality of life, motor function, cognitive function, and social interaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Change in health-related quality of life assessed by the Parkinson's Disease Questionnaire-39 (PDQ-39) from baseline to 8 weeks, comparing the intervention and control groups.
Key secondary outcomes
Safety
Recording of adverse events during the intervention period (continuously, up to 8 weeks).
Acceptability
Questionnaire based on the Theoretical Framework of Acceptability (intervention group only, at 8 weeks).
Adherence
Proportion of completed sessions out of the total 24 prescribed sessions (intervention group only, at 8 weeks).
Feasibility
Six-point Likert scale ratings of fatigue, effort, perceived progress, and enjoyment (intervention group only, at 8 weeks).
Health-related quality of life
12-Item Short Form Health Survey (SF-12, PCS and MCS) (baseline and 8 weeks, between-group comparison).
Motor function
MDS-UPDRS Part III (baseline and 8 weeks, between-group comparison).
Cognitive function
Trail Making Test Part A (TMT-A) and Stroop Color and Word Test (SCWT) (baseline and 8 weeks, between-group comparison).
Social engagement
Lubben Social Network Scale-6 (LSNS-6) and Three-Item Loneliness Scale (TIL scale) (baseline and 8 weeks, between-group comparison).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: In addition to standardized Parkinson's disease rehabilitation (stretching, aerobic exercise, resistance training, and balance training; 20-30 minutes per session, three times per week, for 8 weeks), participants engaged in a universally designed exergame program (UDe-Sports). Exergame sessions were conducted in small groups of 2-4 participants, 15 minutes per session, three times per week, for 8 weeks, under the supervision of rehabilitation professionals. The difficulty level of the games was adjusted according to participants' motor and cognitive abilities.
Interventions/Control_2
Control group: Participants received only standardized Parkinson's disease rehabilitation (stretching, aerobic exercise, resistance training, and balance training; 20-30 minutes per session, three times per week, for 8 weeks).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. who are 30 years of age or older at the time of consent (regardless of gender)
2. who have been diagnosed with PD according to MDS diagnostic criteria
3. who have received a full explanation of their participation in this study, and who have given written consent of their own free will based on full understanding
Key exclusion criteria
1. who have had a change in medication in the past month
2. neurological, orthopedic, and/or cardiovascular conditions that make them unsuitable for the e-sports program
3. visual or hearing impairments that would limit participation in the study
4. who have an MMSE score of less than 18/30
5. who are otherwise deemed unsuitable as research subjects by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makio |
| Middle name | |
| Last name | Takahashi |
Organization
Kansai Medical University
Division name
Department of Neurodegenerative Disorders
Zip code
573-1191
Address
2-5-1, Hirakata-City, Osaka, 573-1010, JAPAN
TEL
072-804-2542
ta@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Makio |
| Middle name | |
| Last name | Takahashi |
Organization
Kansai Medical University
Division name
Department of Neurodegenerative Disorders
Zip code
573-1191
Address
2-5-1, Hirakata-City, Osaka, 573-1010, JAPAN
TEL
072-804-2542
Homepage URL
ta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Sunwels Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1, Hirakata-City, Osaka, 573-1010, JAPAN
Tel
072-804-0101
rinriirb@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
PDハウス岸部（大阪府）PDハウス八尾（大阪府）、PDハウス城東（大阪府）、PDハウス門真（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
The trial has been completed and data analysis has been finished. The results are currently under submission for publication and have not yet been published.
Results date posted
| 2025 | Year | 08 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The trial has been completed and data analysis has been finished. The results are currently under submission for publication and have not yet been published.
Participant flow
The trial has been completed and data analysis has been finished. The results are currently under submission for publication and have not yet been published.
Adverse events
The trial has been completed and data analysis has been finished. The results are currently under submission for publication and have not yet been published.
Outcome measures
The trial has been completed and data analysis has been finished. The results are currently under submission for publication and have not yet been published.
Plan to share IPD
There is no plan to share individual participant data (IPD).
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2026 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062010
