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
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
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
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
