Clinical trial NCT06298331: Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation
Official title: Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation
Keywords: Functional Constipation
Chronic Constipation
Abdominal Massage
Self- abdominal Massage
Aerobic Exercise
Walking
Conservative Treatment
Lifestyle Recommendation
Patient Education
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 observational/manual 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.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Diagnosed with chronic constipation according to Rome IV criteria
* No new treatment for constipation in the last 3 months
* Absence of any condition that would prevent compliance with the interventions and assessments in the study

Exclusion Criteria:

* Presence of secondary constipation ( uncontrolled metabolic disease (uncontrolled DM, hypothyroidism), hyperparathyroidism, neurologic disease or use of anticoagulants, anticholinergics, antihistamines, antipsychotics or opioids)
* In individuals over 50 years of age, the presence of alarm symptoms (new-onset constipation, rectal bleeding, involuntary weight loss, nausea and vomiting, fever and anemia)
* having BMI \> 30 kg/m²
* having cancer diagnosis
* being pregnant or breastfeeding, being within the first year postnatally
* having irritable Bowel Syndrome, Hirschprung's Disease, Crohn's Disease, Inflammatory Bowel Disease, Megacolon diagnosis, Megarectum diagnosis, Rectocele and enterocele stage 3 and above
* presence of advanced systemic disease (e.g. cardiovascular, respiratory, renal or hepatic diseases)
* history of abdomino-pelvic or gastrointestinal surgery in the last 6 months
* presence of open wound, disruption of skin integrity, local tumor, cholestomy or abdominal hernia at the massage site
* Presence of orthopedic (e.g. lumbopelvic pain, advanced knee joint degeneration) and cardiovascular diseases (e.g. acute coronary syndrome, stage 3-4 heart valve diseases) that may prevent aerobic exercise training

Primary outcomes:
measure: Weekly defecation frequency
timeFrame: Change in weekly defecation frequency from 1 week before the interventions to the end of the 1st week after the interventions.
Secondary outcomes:
measure: Average weekly defecation time
timeFrame: Change in weekly duration of defecation from 1 week before the interventions to end of the 1st week after the interventions.
measure: Average weekly frequency of laxative use
timeFrame: Change in weekly frequency of laxative use from 1 week before the interventions to end of the 1st week after the interventions.
measure: Average weekly stool consistency score
timeFrame: Change in weekly stool consistency score from 1 week before the interventions to end of the 1st week after the interventions.
measure: The severity of constipation and associated discomfort
timeFrame: Change in severity of constipation and associated discomfort from baseline up to end of 8th week
measure: The severity of constipation
timeFrame: Change in the severity of constipation from baseline to end of week 8
measure: Gastrointestinal symptom level
timeFrame: Change in gastrointestinal symptom level from baseline to the end of the 8th week
measure: Constipation-related quality of life
timeFrame: Change in constipation-related quality of life from baseline to the end of the 8th week
measure: Patient perception of global change
timeFrame: Patient perception of global change from baseline to the end of 8th week
measure: Abdominal muscle strength
timeFrame: Change in abdominal muscle strength from baseline to the end of the 8th week
measure: Functional exercise capacity
timeFrame: Change in functional exercise capacity from baseline to the end of the 8th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ceren Gursen
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University, Department of Physiotherapy and Rehabilitation
name: Serap ÖZGÜL, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University, Department of Internal Diseases, Division of Gastroenterology
name: Hatice Yasemin BALABAN
role: STUDY_DIRECTOR
References:
citation: Dogan IG, Gursen C, Akbayrak T, Balaban YH, Vahabov C, Uzelpasaci E, Ozgul S. Abdominal Massage in Functional Chronic Constipation: A Randomized Placebo-Controlled Trial. Phys Ther. 2022 Jul 4;102(7):pzac058. doi: 10.1093/ptj/pzac058.
citation: Gao R, Tao Y, Zhou C, Li J, Wang X, Chen L, Li F, Guo L. Exercise therapy in patients with constipation: a systematic review and meta-analysis of randomized controlled trials. Scand J Gastroenterol. 2019 Feb;54(2):169-177. doi: 10.1080/00365521.2019.1568544. Epub 2019 Mar 7.
citation: Sharma A, Rao SSC, Kearns K, Orleck KD, Waldman SA. Review article: diagnosis, management and patient perspectives of the spectrum of constipation disorders. Aliment Pharmacol Ther. 2021 Jun;53(12):1250-1267. doi: 10.1111/apt.16369. Epub 2021 Apr 28.
citation: Pamuk ON, Pamuk GE, Celik AF. Revalidation of description of constipation in terms of recall bias and visual scale analog questionnaire. J Gastroenterol Hepatol. 2003 Dec;18(12):1417-22. doi: 10.1046/j.1440-1746.2003.03155.x.
citation: Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
citation: Varma MG, Wang JY, Berian JR, Patterson TR, McCrea GL, Hart SL. The constipation severity instrument: a validated measure. Dis Colon Rectum. 2008 Feb;51(2):162-72. doi: 10.1007/s10350-007-9140-0. Epub 2008 Jan 3.
citation: McCrea GL, Miaskowski C, Stotts NA, Macera L, Hart SA, Varma MG. Review article: self-report measures to evaluate constipation. Aliment Pharmacol Ther. 2008 Apr;27(8):638-48. doi: 10.1111/j.1365-2036.2008.03626.x. Epub 2008 Jan 23.
citation: Turan N, Ast TA, Kaya N. Reliability and Validity of the Turkish Version of the Gastrointestinal Symptom Rating Scale. Gastroenterol Nurs. 2017 Jan/Feb;40(1):47-55. doi: 10.1097/SGA.0000000000000177.
citation: Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
citation: Bengi G, Yalcin M, Akpinar H, Keskinoglu P, Ellidokuz H. Validity and reliability of the patient assessment of constipation quality of life questionnaire for the Turkish population. Turk J Gastroenterol. 2015 Jul;26(4):309-14. doi: 10.5152/tjg.2015.0185. Epub 2015 Jun 2.
citation: Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
citation: Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.