UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023930
Receipt number R000027556
Scientific Title The effect of exercise on defecation and gut microbiota related to the motivation for physical activity
Date of disclosure of the study information 2016/09/26
Last modified on 2019/09/09 11:49:52

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Basic information

Public title

The effect of exercise on defecation and gut microbiota related to the motivation for physical activity

Acronym

The effect of exercise on defecation and gut microbiota related to the motivation for physical activity

Scientific Title

The effect of exercise on defecation and gut microbiota related to the motivation for physical activity

Scientific Title:Acronym

The effect of exercise on defecation and gut microbiota related to the motivation for physical activity

Region

Japan


Condition

Condition

Healthy elderly women

Classification by specialty

Gastroenterology Geriatrics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of exercise on defecation pattern and gut microbiota, and whether the modification in gut microbiota results in the improvement of the motivation for physical activity

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Microbiota composition and diversity
Total score in Japanese version of Constipation Assessment Scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Core training (resistance training targeting body trunk and pelvic floor muscle) as group-class lessons comprising once of 1-h session a week with 3-month intervention period.

Interventions/Control_2

Aerobic exercise (walking) comprising 1-h session a day with 3-month intervention period.

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

65 years-old <=

Age-upper limit

100 years-old >

Gender

Female

Key inclusion criteria

Healthy sedentary women

Key exclusion criteria

The subjects with arrhythmia, history of ischemic heart disease, chronic heart failure, hypertension (with systolic BP more than 160 mmHg or diastolic BP more than 100 mmHg), and chronic disease such as diabetes, renal dysfunction or neuropsychiatric disorder.
The subjects judged to be inappropriate for enrolled to exercise program.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hisayo
Middle name
Last name Yokoyama

Organization

Osaka City University Graduate School of Medicine

Division name

Environmental Physiology for Exercise

Zip code

558-8585

Address

3-3-138, Sugimoto, Sumiyoshi-ku, Osaka

TEL

06-6605-2947

Email

yokoyama@sports.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Hisayo
Middle name
Last name Yokoyama

Organization

Osaka City University Graduate School of Medicine

Division name

Environmental Physiology for Exercise

Zip code

558-8585

Address

3-3-138, Sugimoto, Sumiyoshi-ku, Osaka

TEL

06-6605-2947

Homepage URL


Email

yokoyama@sports.osaka-cu.ac.jp


Sponsor or person

Institute

Environmental Physiology for Exercise, Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Osaka City 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

Osaka City University Certified Review Board for Medical Research

Address

1-2-7, Asahi-Machi, Abeno-ku, Osaka City

Tel

06-6645-3435

Email

ethics@med.osaka-cu.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

2016 Year 09 Month 26 Day


Related information

URL releasing protocol

https://www.mdpi.com/2072-6643/11/4/868

Publication of results

Unpublished


Result

URL related to results and publications

https://www.mdpi.com/2072-6643/11/4/868

Number of participants that the trial has enrolled

32

Results

K-W test scores and distance achieved during the 6MWT (6MWD) improved in both groups. The relative abundance of intestinal Bacteroides only significantly increased in the AE group, particularly in subjects showing increases in the time spent in brisk walking. Overall, the increases in intestinal Bacteroides following the exercise intervention were associated with increases in 6MWD.

Results date posted

2019 Year 09 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Thirty-two sedentary women that were aged 65 years and older participated in a 12-week, non-randomized comparative trial.

Participant flow

The subjects were allocated to two groups receiving different exercise interventions, trunk muscle training (TM), or aerobic exercise training (AE). AE included brisk walking, i.e., at an intensity of > 3 metabolic equivalents (METs).

Adverse events

None

Outcome measures

The composition of the intestinal microbiota in fecal samples was determined before and after the training period. We also assessed the daily physical activity using an accelerometer, trunk muscle strength by the modified Kraus-Weber (K-W) test, and cardiorespiratory fitness by a 6-min. walk test (6MWT).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 08 Month 30 Day

Date of IRB

2016 Year 08 Month 30 Day

Anticipated trial start date

2016 Year 09 Month 12 Day

Last follow-up date

2018 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

2016 Year 09 Month 05 Day

Last modified on

2019 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027556


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name