UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062239 |
|---|---|
| Receipt number | R000071221 |
| Scientific Title | Effects of a Group Training Program in Convalescent Rehabilitation for Patients with Hip Fractures: A Pilot Study |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/07/15 02:44:19 |
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Basic information
Public title
Effects of a Group Training Rehabilitation for Patients with Hip Fractures: A Pilot Study
Acronym
GRIP Study
Scientific Title
Effects of a Group Training Program in Convalescent Rehabilitation for Patients with Hip Fractures: A Pilot Study
Scientific Title:Acronym
GRIP Study
Region
| Japan |
Condition
Condition
Hip Fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To preliminarily investigate the effects of group training on the improvement of physical and mental functions during inpatient rehabilitation in the recovery phase for patients with proximal hip fractures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Increase in knee extension strength and program adherence 6 weeks after the intervention
Key secondary outcomes
Assessments six weeks after the intervention:
Assessment of cognitive function: Mini-Mental State Examination (MMSE)
Assessment of motivation: Vitality Index (VI)
Assessment of health-related QOL: EuroQol 5-dimensions 5-levels (EQ-5D-5L)
Assessment of pain: Numerical Rating Scale (NRS)
Assessment of muscle strength: Grip strength, Manual Muscle Testing (MMT)
Assessment of joint range of motion: Range of Motion (ROM)
Assessment of physical function (balance, etc.): Functional Reach Test (FRT), Timed Up & Go Test (TUG), Short Physical Performance Battery (SPPB), 10-meter walk time
Assessment of ADL: Functional Independence Measure (FIM)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group
In addition to standard individual rehabilitation, a group exercise program consisting of 30-minute sessions held twice weekly for six weeks (12 sessions in total).
Interventions/Control_2
Control group
In addition to standard individual rehabilitation, a self-directed exercise program consisting of 30-minute sessions twice a week for six weeks (12 sessions in total)
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
Male and female patients aged 65 years or older admitted to a convalescent rehabilitation ward following surgery for a proximal femoral fracture.
Individuals who, upon participation in this study, received a full explanation via a written document (request form) and provided voluntary written consent based on a sufficient understanding of the study.
Key exclusion criteria
Patients deemed unsuitable by the attending physician due to severe comorbidities or similar conditions.
Patients with severe cognitive impairment (MMSE score of 10 or lower).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Metropolitan University
Division name
The Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132, Morinomiya, Joto-ku, Osaka-shi, Osaka 536-8525 JAPAN
TEL
06-6167-1261
Higu_reha@omu.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Matsuura |
Organization
Osaka Metropolitan University
Division name
The Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132, Morinomiya, Joto-ku, Osaka-shi, Osaka 536-8525 JAPAN
TEL
06-6167-1261
Homepage URL
wakatatsu.mmp@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee on Research Ethics of the the Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
2-1-132, Morinomiya, Joto-ku, Osaka-shi, Osaka 536-8525 JAPAN
Tel
06-6167-1261
gr-mrny-reha-rinri@omu.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
社会医療法人若弘会 わかくさ竜間リハビリテーション病院（大阪府）
Wakakusa-Tatsuma Rehabilitation Hospital, Osaka, Japan
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 15 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071221
