Chronic ConstipationNCT06354855
"Which Type of Exercise is More Effective in Chronic Constipation?
A study testing Group is doing breathing exercises while watching videos and Medium pace walking group in people with Chronic Constipation, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Group is doing breathing exercises while watching videos and Medium pace walking group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy or possible pregnancy;
- the habit of doing all kinds of breathing exercises;
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Nezahat Keleşoğlu Health Sciences Necmettin Erbakan University
Konya, Meram, 42000
About this study
Official title: "Which Type of Exercise is More Effective in Chronic Constipation? (Randomized Controlled Study)"
In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation.
Read the 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.
- Conditions
- Chronic Constipation
- Being tested
- Group is doing breathing exercises while watching videos, Medium pace walking group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group is doing breathing exercises while watching videosOther
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.
Medium pace walking groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group is doing breathing exercises while watching videos | Active comparator | Abdominal breathing exercise group .The group, which receives abdominal breathing exercise training, will perform video-assisted breathing exercises for 30 minutes a day. Receives: Other: Group is doing breathing exercises while watching videos |
| Medium pace walking group | Active comparator | Medium pace walking group .Control group will walk at a moderate pace for 30 minutes daily. Receives: Other: Medium pace walking group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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.
Measured: two months
Secondary outcomes (1)
Constipation Severity Scale (CSS)
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
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start15 Feb 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with a conventional therapy control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Erdeo, Necmettin Erbakan University
- Investigators
- Fatma Erdeo, Ph D, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354855
- Sponsor's protocol ID
- NEU-FTR-FE-04
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Which Type of Exercise is More Effective in Chronic Constipation? (Randomized Controlled Study)"
- ClinicalTrials.gov ID
- NCT06354855
- Acronym / sponsor ID
- NEU-FTR-FE-04
- Conditions
- Chronic Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with a conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Group is doing breathing exercises while watching videos | Active comparator | Other: Group is doing breathing exercises while watching videosAbdominal breathing exercise group .The group, which receives abdominal breathing exercise training, will perform video-assisted breathing exercises for 30 minutes a day. |
| Medium pace walking group | Active comparator | Other: Medium pace walking groupMedium pace walking group .Control group will walk at a moderate pace for 30 minutes daily. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- pregnancy or possible pregnancy;
- the habit of doing all kinds of breathing exercises;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group is doing breathing exercises while watching videosGroup 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. | Other | Group is doing breathing exercises while watching videos |
| Medium pace walking groupMedium pace walking group: 30 minutes daily. Walking at a moderate pace is required. Physical activity levels will be monitored with the ActiGraph GT3X+ Accelerometer. | Other | Medium pace walking group |
Primary outcome
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.
1 secondary outcome
Constipation Severity Scale (CSS)
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Erdeo, Ph D principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group is doing breathing exercises while watching videos and Medium pace walking group in people with Chronic Constipation, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.