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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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). 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 r
• Другое 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.
• Другое Patient Education
  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.

Первичные конечные точки

• Weekly defecation frequency [Срок оценки: Change in weekly defecation frequency from 1 week before the interventions to the end of the 1st week after the interventions.]

Вторичные конечные точки (10)

• Average weekly defecation time [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Change in severity of constipation and associated discomfort from baseline up to end of 8th week]
• The severity of constipation [Срок оценки: Change in the severity of constipation from baseline to end of week 8]
• Gastrointestinal symptom level [Срок оценки: Change in gastrointestinal symptom level from baseline to the end of the 8th week]
• Constipation-related quality of life [Срок оценки: Change in constipation-related quality of life from baseline to the end of the 8th week]
• Patient perception of global change [Срок оценки: Patient perception of global change from baseline to the end of 8th week]
• Abdominal muscle strength [Срок оценки: Change in abdominal muscle strength from baseline to the end of the 8th week]
• Functional exercise capacity [Срок оценки: Change in functional exercise capacity from baseline to the end of the 8th week]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 2 центра

• Ceren Gursen — Ankara
• Hacettepe University — Ankara

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06298331 · KA-23073

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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