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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

Feasibility, acceptability, safety, and potential effectiveness of an exergame program for patients with advanced Parkinson's disease: a pilot randomized controlled trial - Exergame-Advanced PD Pilot RCT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054292
Enrollment
60
Registered
2024-05-08
Start date
2024-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&#39

Interventions

Intervention group: In addition to standardized Parkinson&#39
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 par
motor and cognitive abilities. Control group: Participants received only standardized Parkinson&#39
20-30 minutes per session, three times per week, for 8 weeks).

Sponsors

Kansai Medical University
Lead Sponsor
National Center for Geriatrics and Gerontology
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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). Semi-structured interviews

Countries

Japan

Contacts

Public ContactMakio Takahashi

Kansai Medical University Department of Neurodegenerative Disorders

ta@kuhp.kyoto-u.ac.jp072-804-2542

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026