UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059898 |
|---|---|
| Receipt number | R000068501 |
| Scientific Title | Safety and Efficacy of a Remote Rehabilitation Program for Older Adults with Frailty or Prefrailty: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/11/27 |
| Last modified on | 2025/11/27 13:31:51 |
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Basic information
Public title
Evaluation of the Safety and Efficacy of a Remote Rehabilitation Program for Older Adults with Frailty or Prefrailty
Acronym
Tele-Reha Study
Scientific Title
Safety and Efficacy of a Remote Rehabilitation Program for Older Adults with Frailty or Prefrailty: A Randomized Controlled Trial
Scientific Title:Acronym
Tele-Reha RCT
Region
| Japan |
Condition
Condition
Frailty or Pre frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare a remote rehabilitation program with self-directed training consisting of exercise instruction alone in older adults with frailty or prefrailty, and to evaluate the safety and efficacy of the remote rehabilitation program through a randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint
Safety:
Adverse events occurring during remote rehabilitation
Hospital readmission
Incidence of falls
Efficacy:
Rate of change in handgrip strength
Rate of change in the Short Physical Performance Battery (SPPB) score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group:
Participants receive remote rehabilitation once per week using a tablet device and video communication (FaceTime or Skype). Vital signs are measured prior to exercise to confirm safety. Patients also perform home-based exercises using provided instructional videos.
Common procedures:
Both groups undergo activity monitoring using a wearable device (Fitbit).
Randomization is conducted using a stratified permuted block method with BMI as the stratification factor, implemented through an Interactive Web Response System (IWRS; RedCAP).
Interventions/Control_2
Control group:
Participants perform self-directed training based only on exercise instruction. Exercise adherence is reviewed during routine outpatient visits, and additional instruction is provided as needed.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Regularly attending outpatient clinics in the relevant departments
2.Over 65 years old
3.Able to walk independently (including with a cane)
4.Provided written informed consent
5.Living with a cohabiting family member
Key exclusion criteria
1.Unable to walk independently or unable to complete interviews/questionnaires
2.Severe cerebrovascular, cardiac, respiratory, hepatic, renal, gastrointestinal, or endocrine/metabolic disease
3.Estimated life expectancy is less than one year due to malignancy or other conditions
4.Severe physical disability requiring long-term rehabilitation
5.Deemed ineligible for participation by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsumi |
| Middle name | |
| Last name | Miyauchi |
Organization
Juntendo University School of Medicine Affiliated Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Cardiology
Zip code
136-0075
Address
Shinsuna 3-3-20, Koto-ku, Tokyo, Japan
TEL
03-5632-3111
ktmmy@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Matsuno |
Organization
Juntendo University School of Medicine Affiliated Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Respiratory medicine
Zip code
1350075
Address
Shinsuna 3-3-20, Koto-ku, Tokyo, Japan
TEL
0356323111
Homepage URL
kmatsuno@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
Tel
0358021584
hongo-rinri@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 27 | 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
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068501
