Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298331
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-11-07
Brief Title:
Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation However to the best of our knowledge there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects By combining these two approaches we believe that a higher and broader effect local and systemic and perhaps a cure for constipation reaching the ideal defecation frequency or asymptomatic status can be achieved Therefore this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study This study is designed as a randomized controlled trial
Detailed Description:
The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation However to the best of our knowledge there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects By combining these two approaches we believe that a higher and broader effect local and systemic and perhaps a cure for constipation reaching the ideal defecation frequency or asymptomatic status can be achieved Therefore this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study This study is designed as a randomized controlled trial A total of 44 individuals will be randomly assigned to 2 groups Patients in group 1 will receive patient education with abdominal massage and aerobic exercise training Patients in Group 2 will receive only abdominal massage and patient education Abdominal massage and aerobic exercise will be practiced 8 weeks 3 days a week in the clinic under the supervision of a physiotherapist and 8 weeks 2 days a week outside the clinic Patient education includes information about constipation and lifestyle recommendations for constipation Physical sociodemographic medical and lifestyle characteristics of the individuals will be recorded as descriptive measurements Among the descriptive characteristics physical activity level will be assessed with the International Physical Activity Questionnaire-Short Form and the presence of diastasis recti abdominis will be assessed with the finger width test Outcome measures of weekly defecation frequency defecation time laxative use frequency and average stool consistency score will be recorded by the 7-Day Bowel Diary Stool consistency will be questioned with the Bristol Stool Scale Other outcome measures will be severity of constipation by the Constipation Severity Scale and Constipation Scoring System gastrointestinal symptom level by the Gastrointestinal Symptom Rating Scale constipation-related quality of life by the Constipation Quality of Life Scale abdominal muscle strength by the observationalmanual muscle strength test and functional exercise capacity by the 6-min walking test All outcome measurements will be performed at baseline and at the end of the 8th week Perception change will be assessed using the Patient Perception of Global Change Scale and compliance with lifestyle recommendations will be assessed using the Numeric Rating Scale The compliance of patients with exercise and massage sessions will be assessed using diaries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None