UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047079
Receipt number R000053706
Scientific Title The Effect of Exercise Experience on Pelvic Floor Muscle Function and Physical Function
Date of disclosure of the study information 2022/03/04
Last modified on 2023/09/04 10:54:07

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Basic information

Public title

The Effect of Exercise Experience on Pelvic Floor Muscle Function and Physical Function

Acronym

The Effect of Exercise Experience on Pelvic Floor Muscle Function and Physical Function

Scientific Title

The Effect of Exercise Experience on Pelvic Floor Muscle Function and Physical Function

Scientific Title:Acronym

The Effect of Exercise Experience on Pelvic Floor Muscle Function and Physical Function

Region

Japan


Condition

Condition

Healthy adult women

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to determine the effects of exercise experience on pelvic floor muscle function and physical function in healthy adult women.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pelvic floor elevation by transabdominal ultrasound

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

(1) those who continue to exercise

Interventions/Control_2

(2) those who have exercised

Interventions/Control_3

(3) those who have not exercised.

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


Not applicable

Gender

Female

Key inclusion criteria

Health adult women

Key exclusion criteria

Cognitive disorders
Movement disorders
Sensory disorder

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yui
Middle name
Last name Abe

Organization

Hokkaido University of Science

Division name

Department of Physical Therapy Faculty of Health Sciences

Zip code

006-8585

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

TEL

011-688-2305

Email

abe-y@hus.ac.jp


Public contact

Name of contact person

1st name Yui
Middle name
Last name Abe

Organization

Hokkaido University of Science

Division name

Department of Physical Therapy Faculty of Health Sciences

Zip code

006-8585

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

TEL

011-688-2305

Homepage URL


Email

abe-y@hus.ac.jp


Sponsor or person

Institute

Hokkaido University of Science

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University of Science

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

Hokkaido University of Science Ethics Committee

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

Tel

011-688-2305

Email

abe-y@hus.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

2022 Year 03 Month 04 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

18

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

2022 Year 03 Month 01 Day

Date of IRB

2022 Year 04 Month 12 Day

Anticipated trial start date

2022 Year 04 Month 12 Day

Last follow-up date

2024 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 03 Month 04 Day

Last modified on

2023 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053706