UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060034 |
|---|---|
| Receipt number | R000068643 |
| Scientific Title | The immediate effects of mat Pilates on ankle range of motion and physical function in healthy university students: A before-and-after comparative study |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/10 11:02:39 |
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Basic information
Public title
The immediate effects of mat Pilates on ankle range of motion and physical function in healthy university students
Acronym
The immediate effects of mat Pilates on ankle range of motion and physical function in healthy university students
Scientific Title
The immediate effects of mat Pilates on ankle range of motion and physical function in healthy university students: A before-and-after comparative study
Scientific Title:Acronym
The immediate effects of mat Pilates on ankle range of motion and physical function in healthy university students: A before-and-after comparative study
Region
| Japan |
Condition
Condition
Healthy university students
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the effects of mat Pilates exercise on ankle joint function in healthy university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Passive ankle dorsiflexion range of motion (angle): Change before and after intervention Measurement time: Immediately before and after intervention
Key secondary outcomes
Passive joint range of motion (hip flexion/extension, knee flexion/extension, ankle plantar flexion), ankle dorsiflexion range of motion under weight (angle/distance), Y-balance test, single-leg hop test, triple hop test, walking (joint angle, gait): Immediately before and after intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Mat Pilates Exercises
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are currently living their daily lives without pain.
2. Subjects who currently do not experience pain during exercise.
3. Subjects who have not experienced Pilates in the past six months.
Key exclusion criteria
1. Patients with a history of musculoskeletal (bone, joint, or nerve) surgery on any of the lower extremities.
2. Patients with acute musculoskeletal trauma (sprain, fracture, or dislocation) of any other lower extremity joint within the past three months that affected the integrity or function of the joint and required interruption of physical activity for at least one day.
3. Patients with chronic medical conditions (high blood pressure, heart disease, or conditions that limit physical activity).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miku |
| Middle name | |
| Last name | Kasaya |
Organization
Gunma University
Division name
Graduate School of Health Sciences Takumi Kobayashi Laboratory
Zip code
3710034
Address
39-22 Showacho, Maebashi City, Gunma Prefecture
TEL
027-220-7111
m-kasaya@chitose-reha.ac.jp
Public contact
Name of contact person
| 1st name | Miku |
| Middle name | |
| Last name | Kasaya |
Organization
Hokkaido Chitose Rehabilitation University
Division name
Faculty of Health Sciences, Department of Rehabilitation, Physical Therapy Major
Zip code
0650010
Address
2-10 Satomi, Chitose City, Hokkaido
TEL
0123285331
Homepage URL
m-kasaya@chitose-reha.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Chitose Rehabilitation University
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
Gunma University Graduate School of Health Sciences
Address
39-22 Showacho, Maebashi City, Gunma Prefecture
Tel
027-220-7111
cme.gunma.univ@gmail.com
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
北海道千歳リハビリテーション大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 10 | 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
| 2025 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | 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 | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068643
