- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06354855
"Which Type of Exercise is More Effective in Chronic Constipation?
"Which Type of Exercise is More Effective in Chronic Constipation? (Randomized Controlled Study)"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to the results of population-based studies conducted in our country, the frequency of constipation varies between 22-40%. In addition to medical treatment, alternative treatments are frequently used in the treatment of constipation. One of these is exercise.
In addition to medical treatment, alternative treatments are frequently used in the treatment of constipation. One of these is exercise. Many traditional breathing techniques developed in Asia are thought to be beneficial to health. In the light of this information, it is aimed to monitor ActiGraph GT3X+ Accelerometer, which is an objective measurement method of physical activity, and to evaluate the effectiveness of breathing exercise, which is one of the abdominal breathing exercises.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Meram
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Konya, Meram, Turkey, 42000
- Faculty of Nezahat Keleşoğlu Health Sciences Necmettin Erbakan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to speak and understand Turkish,
- Voluntarily accepted to participate in the research and written consent form was obtained (those who could fill out the forms themselves using their hands, and those who could not use it, from their relatives with verbal consent),
- At least 18 years of age and over,
- Oriented to place, person and time,
- Patients who do not have spinal cord injury, parapilegia, or quadriplegia that may physiologically impede the individual's intestinal excretion Does not have any problems that prevent cognitive, sensory and verbal communication,
- Patients who are conscious and not using any sedating medication
- men and women aged 20-80 at the time of approval
Exclusion Criteria:
- pregnancy or possible pregnancy;
- the habit of doing all kinds of breathing exercises;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group is doing breathing exercises while watching videos
Abdominal breathing exercise group .The group, which receives abdominal breathing exercise training, will perform video-assisted breathing exercises for 30 minutes a day.
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Group is doing breathing exercises while watching videos: A video consisting of 30-minute exercises will be shot for these patients.
And each patient will be asked to do the breathing exercise for 30 minutes by watching this video.
|
|
Active Comparator: Medium pace walking group
Medium pace walking group .Control group will walk at a moderate pace for 30 minutes daily.
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Medium pace walking group: 30 minutes daily.
Walking at a moderate pace is required.
Physical activity levels will be monitored with the ActiGraph GT3X+ Accelerometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: two months
|
In order to determine the severity of constipation and the degree of impact of their current situation on their lives, individuals will be asked to mark a suitable point on a horizontal line with an actual length of 10 cm.
In terms of the impact of the current situation on my life, "0" means it has no impact on my life, and "10" means living like this is unbearable.
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two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constipation Severity Scale (CSS)
Time Frame: two months
|
Constipation Severity Scale (CSS):There are 16 questions in total.
The Constipation Severity Scale has three subscales: Fecal obstruction (FO), Large Intestinal Laziness (LIL) and Pain.
The score that can be obtained from the FO sub-dimension is 0-28, the score that can be obtained from the LIL sub-dimension is 0-29,the score that can be received from the Pain sub-dimension is 0-16, and the lowest score that can be obtained from the CSS is 0 and the highest score is 73.High taken from the scale score indicates that symptoms are severe
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two months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chronic Constipation Quality of Life Scale
Time Frame: two months
|
The PAC-QOL survey consists of 28 questions, and based on the factor analysis structure, the instrument consists of four subscales: "Physical discomfort (questions 1-4)," "Psychosocial discomfort (questions 5-12)," "Worries and concerns."
(questions 13-23)" and "Satisfaction (questions 24-28)."
Similar to a Likert scale, each option is scored from 0-4 (least to greatest impact), with higher scores indicating the worst quality of life.
However, since questions 18, 25, 26, 27 and 28 were positive and the other 23 questions were negative, reverse coding was required.
|
two months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma Erdeo, Ph D, Necmettin Erbakan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU-FTR-FE-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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