Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation

NCT06298331 | Recruiting

• 1 other identifier: KA-23073
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Constipation

Keywords

Functional Constipation; Chronic Constipation; Abdominal Massage; Self- abdominal Massage; Aerobic Exercise; Walking; Conservative Treatment; Lifestyle Recommendation; Patient Education

Outcome Measures

Primary Outcomes (1)

• Weekly defecation frequency

  The bowel diary developed by Pamuk et al. is a widely used and practical diary that records defecation frequency, defecation duration, stool consistency, gas/fecal incontinence, pain during defecation and amount of laxative use. The 7-day bowel diary will be used to record weekly defecation frequency for a period of 1 week before the interventions and within 1 week following the end of the interventions

  Change in weekly defecation frequency from 1 week before the interventions to the end of the 1st week after the interventions.

Secondary Outcomes (10)

• Average weekly defecation time

  Change in weekly duration of defecation from 1 week before the interventions to end of the 1st week after the interventions.

• Average weekly frequency of laxative use

  Change in weekly frequency of laxative use from 1 week before the interventions to end of the 1st week after the interventions.

• Average weekly stool consistency score

  Change in weekly stool consistency score from 1 week before the interventions to end of the 1st week after the interventions.

• The severity of constipation and associated discomfort

  Change in severity of constipation and associated discomfort from baseline up to end of 8th week

• The severity of constipation

  Change in the severity of constipation from baseline to end of week 8

Study Arms (2)

Aerobic Exercise and Abdominal Massage

EXPERIMENTAL

Aerobic Exercise: Aerobic exercise training will be given for 8 weeks, 3 days a week on the treadmill in the clinic under the supervision of a physiotherapist, and 8 weeks, the other 2 days a week outside the clinic. The duration of the walking session is 50 minutes (5 minutes warm-up - 40 minutes load - 5 minutes cool down). Abdominal Massage: Abdominal massage will be performed manually by applying baby oil to the patient's abdomen and while the patient is in the supine position. This application will take approximately 15 minutes. The massage will be performed by the physiotherapist in the clinic 3 days a week for 8 weeks and by the patient outside the clinic 2 days a week for 8 weeks as self-massage.

Other: Aerobic Exercise; Other: Abdominal Massage; Other: Patient Education

Abdominal Massage

ACTIVE COMPARATOR

Abdominal Massage: Abdominal massage will be performed manually by applying baby oil to the patient's abdomen and while the patient is in the supine position. This application will take approximately 15 minutes. The massage will be performed by the physiotherapist in the clinic 3 days a week for 8 weeks and by the patient outside the clinic 2 days a week for 8 weeks as self-massage.

Other: Abdominal Massage; Other: Patient Education

Interventions

Aerobic Exercise OTHER

Aerobic exercise training will be given for 8 weeks, 3 days a week on the treadmill in the clinic under the supervision of a physiotherapist, and 8 weeks, the other 2 days a week outside the clinic. The duration of the walking session is 50 minutes (5 minutes warm-up - 40 minutes load - 5 minutes cool down). Walking speed in the clinic will be determined according to the Heart Rate Reserve(HRR) method. In the warm-up and cool-down phases in the clinic, the walking speed will be adjusted in the range of 20-40% of HRR, while in the loading phase it will be adjusted in the range of 40-60% of HRR. Heart rate will be monitored with a monitor that detects heart rate by hand contact on the treadmill. Outside the clinic, walking speed will be determined according to the level of fatigue perceived on the Borg Scale. Outside the clinic, walking speed will be regulated as 10-12 (light) on the Borg scale during warm-up and cool-down phases and 12-14 (slightly difficult) during the loading period.

Aerobic Exercise and Abdominal Massage

Abdominal Massage OTHER

Abdominal massage will be performed manually by applying baby oil to the patient's abdomen and while the patient is in the supine position. This application will take approximately 15 minutes. The massage will be performed by the physiotherapist in the clinic 3 days a week for 8 weeks and by the patient outside the clinic 2 days a week for 8 weeks as self-massage.

Abdominal Massage; Aerobic Exercise and Abdominal Massage

Patient Education OTHER

Patient education will include information on the definition of constipation, causes of constipation, how constipation occurs, factors affecting constipation, concepts related to constipation, treatment options for constipation, and lifestyle recommendations for constipation, including increasing fluid intake, regulating nutrition, increasing physical activity, and regulating toilet habits.

Abdominal Massage; Aerobic Exercise and Abdominal Massage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (2)

Ceren Gursen

Ankara, 06100, Turkey (Türkiye)

NOT YET RECRUITING

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (12)

• 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.

  PMID: 35554601 BACKGROUND

• 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.

  PMID: 30843436 BACKGROUND

• 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.

  PMID: 33909919 BACKGROUND

• 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.

  PMID: 14675272 BACKGROUND

• 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.

  PMID: 9299672 BACKGROUND

• 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.

  PMID: 18172725 BACKGROUND

• 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.

  PMID: 18221405 BACKGROUND

• 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.

  PMID: 28134719 BACKGROUND

• 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.

  PMID: 16036506 BACKGROUND

• 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.

  PMID: 26039000 BACKGROUND

• 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.

  PMID: 20046623 BACKGROUND

• 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.

  PMID: 25359356 BACKGROUND

MeSH Terms

Conditions

Constipation

Interventions

Exercise; Patient Education as Topic

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Serap ÖZGÜL, Prof

  Hacettepe University, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Hatice Yasemin BALABAN

  Hacettepe University, Department of Internal Diseases, Division of Gastroenterology

  STUDY DIRECTOR

Central Study Contacts

Serap Özgül, Prof

CONTACT

+905339390803; serapky@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: March 7, 2024
• Study Start: March 15, 2024
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)