UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052519 |
|---|---|
| Receipt number | R000059933 |
| Scientific Title | Effect of exercise on abdominal symptoms of irritable bowel syndrome and functional constipation - Development of a constipation exercise program - |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2024/03/26 11:54:07 |
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Basic information
Public title
Effect of exercise on abdominal symptoms of irritable bowel syndrome and functional constipation - Development of a constipation exercise program -
Acronym
Effects of exercise on irritable bowel syndrome and functional constipation
Scientific Title
Effect of exercise on abdominal symptoms of irritable bowel syndrome and functional constipation - Development of a constipation exercise program -
Scientific Title:Acronym
Effects of exercise on irritable bowel syndrome and functional constipation
Region
| Japan |
Condition
Condition
irritable bowel syndrome, functional constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the effects of exercise on the clinical findings of irritable bowel syndrome and functional constipation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in gastrointestinal symptoms (GSRS score, intestinal gas) due to physical activity.
Key secondary outcomes
Changes in body mass index (BMI), body fat percentage, muscle mass, mental health, and quality of life (QOL) due to physical activity.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the exercise intervention group will perform the "Constipation Exercise Program" performing two sets of 10 to 15 minutes of exercise per day for 14 to 28 days
Interventions/Control_2
Participants in the non-exercise intervention group will not perform the "Constipation Exercise Program Exercise" for 14 to 28 days
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
Health check-up patients diagnosed with irritable bowel syndrome (IBS) or functional constipation (FC) according to ROME IV criteria
Key exclusion criteria
Patients with a history of surgery for gastrointestinal malignant tumors and patients with organic illness such as inflammatory bowel disease will be excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Sumi |
Organization
Kawasaki Medical School Hospital
Division name
Health Check-up Center
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
n.sumi@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Sumi |
Organization
Kawasaki Medical School Hospital
Division name
Health Check-up Center
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
n.sumi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
The KAWASAKI Foundation for Medical Science and Medical Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki medical school internal review board
Address
577 Matsushima, Kurashiki, Okayama
Tel
086-464-1076
kmsrec@med.kawasaki-m.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
| 2023 | Year | 11 | Month | 15 | 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
24
Results
Twelve patients were enrolled in each of the exercise group and rest group. In the exercise group, there was a significant improvement in the GSRS constipation score after participating in the study compared to the time of participation (p<0.05). In addition, the SF-36 mental summary score showed a significant improvement only in the exercise group (p<0.05). There was no difference in the amount of intestinal gas observed on X-rays during and after participation.
Results date posted
| 2024 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among female patients aged 20 to 64 who visited our health checkup center from January to March 2024, patients were diagnosed with IBS or FC using a questionnaire based on ROME IV criteria.
Participant flow
Female patients aged 20 to 64 who visited our health checkup center from January to March 2024.
Adverse events
Nothing in particular
Outcome measures
Gastrointestinal symptoms (constipation score Gastrointestinal Symptom Rating Scale: GSRS)
QOL (physical and mental summary score: SF-36)
Changes in the amount of gas in the intestinal tract evaluated by abdominal X-ray (measured by Image-J)
Muscle mass, body fat mass (INBODY)
Plan to share IPD
The questionnaire is managed in a locked storage room.
Electronic data is stored in an electromagnetic recording medium that requires password authentication, and is managed in a locked storage facility.
IPD sharing Plan description
The questionnaire is managed in a locked storage room.
Electronic data is stored in an electromagnetic recording medium that requires password authentication, and is managed in a locked storage facility.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059933
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