UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063380 |
|---|---|
| Receipt number | R000072543 |
| Scientific Title | Effects of a 4-Week Progressive Squat Exercise Program Using a Passive Assistive Suit on Exercise Motivation and Lower-Limb Physical Function in University Students Without Regular Exercise Habits: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/22 |
| Last modified on | 2026/10/22 22:36:58 |
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Basic information
Public title
Effects of a 4-Week Progressive Squat Exercise Program Using a Passive Assistive Suit on Exercise Motivation in University Students Without Regular Exercise Habits: A Randomized Controlled Trial
Acronym
Passive Assistive Suit and Exercise Motivation Study
Scientific Title
Effects of a 4-Week Progressive Squat Exercise Program Using a Passive Assistive Suit on Exercise Motivation and Lower-Limb Physical Function in University Students Without Regular Exercise Habits: A Randomized Controlled Trial
Scientific Title:Acronym
Passive Assistive Suit and Exercise Motivation Study
Region
| Japan |
Condition
Condition
Not applicable (healthy university students without regular exercise habits)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effects of squat exercise performed while wearing a passive assistive suit on longitudinal changes in exercise motivation and physical function among University Students without regular exercise habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Each behavioral regulation subscale of the BREQ-3 and the Relative Autonomy Index (RAI)
Key secondary outcomes
Intention to continue exercising, the 30-second chair-stand test (CS-30), and zaRitz-derived parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Assistive suit group EXO. Participants wore a passive assistive suit DARWING UT-Rise manufactured by Daiya Industry Co Ltd Okayama Japan and performed squat exercises three times per week for 4 weeks. Each session comprised three sets of 8-12 repetitions. Exercise load was progressively increased according to the participants' achievement of the prescribed repetitions based on the recommendations of the American College of Sports Medicine. Exercise sessions were generally conducted under the supervision of the principal investigator. When supervised exercise was not feasible participants recorded their exercise sessions at home and the recordings were subsequently reviewed by the principal investigator.
Interventions/Control_2
Control group CON. Participants performed squat exercises without wearing the passive assistive suit three times per week for 4 weeks. Each session comprised three sets of 8-12 repetitions. Exercise load was progressively increased according to the participants' achievement of the prescribed repetitions based on the recommendations of the American College of Sports Medicine. Exercise sessions were generally conducted under the supervision of the principal investigator. When supervised exercise was not feasible participants recorded their exercise sessions at home and the recordings were subsequently reviewed by the principal investigator.
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. University students aged 18 years or older
2. Individuals who did not meet the criterion for regular exercise habits, defined as engaging in exercise for at least 30 minutes per session, at least twice per week, for at least 1 year
3. Individuals who received a full explanation of the study and provided written informed consent to participate
Key exclusion criteria
1. Individuals with medical restrictions on exercise
2. Individuals with musculoskeletal pain or injury that could interfere with squat exercise
3. Individuals with cardiovascular, respiratory, neurological, or other medical conditions that could affect safe participation
4. Individuals with any other condition judged by the investigators to make participation inappropriate
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Taki |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima
TEL
082-424-6838
staki@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Taki |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima
TEL
082-424-6838
Homepage URL
staki@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Shingo Taki
Funding Source
Organization
Hiroshima University
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
Research Ethics Review Board, Graduate School of Humanities and Social Sciences, Hiroshima University
Address
1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima
Tel
082-424-6705
ed-ken-zai@office.hiroshima-u.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
| 2026 | Year | 10 | Month | 22 | 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
22
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
Completed
Date of protocol fixation
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 22 | Day |
Last modified on
| 2026 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072543
