UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043847
Receipt number R000050046
Scientific Title The storage duration of motor learning in the transversus abdominis muscle by home exercise with the abdominal draw-in maneuver
Date of disclosure of the study information 2021/06/01
Last modified on 2023/04/08 01:17:14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

How long does the training for deep abdominal muscles keep?

Acronym

Duration of deep abdominal muscles training

Scientific Title

The storage duration of motor learning in the transversus abdominis muscle by home exercise with the abdominal draw-in maneuver

Scientific Title:Acronym

The storage duration of the skill for draw-in maneuver

Region

Japan


Condition

Condition

healthy person

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the storage duration of selective contraction in the transversus abdominis by a instruction of draw-in maneuver and home exercise

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle thickness of transversus abdominis, internal oblique, and external oblique: pre and post instruction, post 1 w, 2w, 3w, and 4w

Key secondary outcomes

Questionnaire of subjective difficulty and achivement of draw-in maneuver


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

Maneuver

Interventions/Control_1

selective contraction of the transversus abdominis by draw-in maneuver, home exercise (20 rep, 3 sets)

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male

Key inclusion criteria

healthy men

Key exclusion criteria

history of spinal orthopaedic disease
low back pain within 3 months
experience of instruction for draw-in maneuver

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yu
Middle name
Last name Okubo

Organization

Saitama Medical University

Division name

School of Physical Therapy, Faculty of Health and Medical Care

Zip code

3500496

Address

981, Kawakado, Moroyama-machi, Saitama

TEL

0492951001

Email

yokubo@saitama-med.ac.jp


Public contact

Name of contact person

1st name Yu
Middle name
Last name Okubo

Organization

Saitama Medical University

Division name

School of Physical Therapy, Faculty of Health and Medical Care

Zip code

3500496

Address

981, Kawakado, Moroyama-machi, Saitama

TEL

0492951001

Homepage URL


Email

yokubo@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical 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

Ethical Committee of Saitama Medical University

Address

38, Hongo, Moroyama-machi, Saitama

Tel

049-276-2143

Email

rinri@saitama-med.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

2021 Year 06 Month 01 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/jossm/42/2/42_89/_article/-char/ja/

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jossm/42/2/42_89/_article/-char/ja/

Number of participants that the trial has enrolled

14

Results

The Transversus abdominis (TrA) preferential thickness ratios at post-0, post-3 day post-7 day were significantly greater than that before the instruction. In conclusion, the results showed that storage duration to keep selective contraction of the TrA with home exercise might be 7 days. Therefore, it is recommended that instruction from a therapist at least once a week is needed for optimal TrA contraction.

Results date posted

2023 Year 04 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

healthy men

Participant flow

Instruction of this experiment, prior measurement, instruction of draw-in maneuver, post-0 measurement, post- 3 day measurement, post- 7 day measurement, post- 10 day measurement, post- 14 day measurement

Adverse events

Nothing

Outcome measures

abdominal muscle thickness

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 04 Month 01 Day

Date of IRB

2021 Year 06 Month 28 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2022 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

2021 Year 04 Month 05 Day

Last modified on

2023 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050046


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name