UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023930
Receipt No. 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 (Ver. 9)

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027556