UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059973 |
|---|---|
| Receipt number | R000068602 |
| Scientific Title | Immediate Effects of Thoracic Extension Exercise on Pectoralis Minor Shear Modulus and Shoulder Horizontal Abduction Range of Motion: A Randomized Controlled Trial Using Shear Wave Elastography |
| Date of disclosure of the study information | 2025/12/06 |
| Last modified on | 2025/12/04 15:48:15 |
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Basic information
Public title
Immediate Effects of Thoracic Extension Exercise on Pectoralis Minor Stiffness and Shoulder Horizontal Abduction Range of Motion: A Randomized Controlled Trial
Acronym
TEE-PM Study
Scientific Title
Immediate Effects of Thoracic Extension Exercise on Pectoralis Minor Shear Modulus and Shoulder Horizontal Abduction Range of Motion: A Randomized Controlled Trial Using Shear Wave Elastography
Scientific Title:Acronym
TEE-PM SWE Trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether a short-duration thoracic extension exercise produces immediate improvements in pectoralis minor stiffness measured by shear wave elastography and in shoulder horizontal abduction range of motion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pectoralis minor shear modulus measured by shear wave elastography.
Evaluation timing: before and after the intervention.
Key secondary outcomes
Shoulder horizontal abduction range of motion measured using a goniometer.
Evaluation timing: before and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Participants perform a 10-minute thoracic extension exercise in a seated position.
The exercise consists of repeated thoracic extension movements performed at a comfortable tempo.
The intervention is conducted once.
Interventions/Control_2
No intervention.
Participants remain seated at rest for 10 minutes.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older
No current shoulder or thoracic pain or disorders
No history of thoracic or shoulder injury or surgery within the past 6 months
Provided written informed consent to participate in the study
Key exclusion criteria
History of cardiac or respiratory disease that limits physical activity
Pregnant individuals
Musculoskeletal disorders that may affect SWE or ROM measurements
Individuals deemed inappropriate for participation by the investigators
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | Okanishi |
Organization
Hirabari Kato Orthopedics & Sports Clinic
Division name
Department of Rehabilitation
Zip code
470-0126
Address
310 Yakita, Akaike-cho, Nisshin, Aichi, Japan
TEL
090-8322-6092
vanvan4575@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hisato |
| Middle name | |
| Last name | Okanishi |
Organization
Hirabari Kato Orthopedics & Sports Clinic
Division name
Department of Rehabilitation
Zip code
470-0126
Address
310 Yakita, Akaike-cho, Nisshin, Aichi, Japan
TEL
090-8322-6092
Homepage URL
vanvan4575@yahoo.co.jp
Sponsor or person
Institute
Hirabari Kato Orthopedics & Sports Clinic
Institute
Department
Personal name
Funding Source
Organization
Hirabari Kato Orthopedics & Sports Clinic
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
Hirabari Kato Orthopedics & Sports Clinic
Address
310 Yakita, Akaike-cho, Nisshin, Aichi, Japan
Tel
090-8322-6092
vanvan4575@yahoo.co.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
平針かとう整形外科スポーツクリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Not applicable (addressed by result registration)
Publication of results
Unpublished
Result
URL related to results and publications
The study results are currently being prepared for journal submission and are not yet publicly avail
Number of participants that the trial has enrolled
18
Results
The primary outcome, the shear modulus of the pectoralis minor, showed a significant decrease in the exercise group but no significant change in the non-exercise group. The secondary outcome, shoulder horizontal abduction range of motion, increased significantly in the exercise group, whereas no notable change was observed in the control group.
Results date posted
| 2025 | Year | 12 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 18 healthy adults participated in the study and were randomly allocated to the intervention group (n = 9) or the control group (n = 9). There were no significant between-group differences in age, sex, height, weight, baseline shoulder horizontal abduction angle, or baseline pectoralis minor shear modulus.
Participant flow
Eighteen individuals were screened and all met the eligibility criteria and were randomized. Nine participants were allocated to the intervention group and nine to the control group. All participants completed both pre- and post-intervention assessments, and no dropouts occurred.
Adverse events
No adverse events were observed during the study period.
Outcome measures
The primary outcome measure was the shear modulus of the pectoralis minor, assessed using shear wave elastography. The secondary outcome measure was the shoulder horizontal abduction range of motion, evaluated using a goniometer. Changes before and after the intervention were compared.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 02 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068602
