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

Last updated: January 17, 2025
Sponsor: Hacettepe University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Treatment

Abdominal Massage

Patient Education

Aerobic Exercise

Clinical Study ID

NCT06298331
KA-23073
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andassessments in the study

Exclusion

Exclusion Criteria:

  • Presence of secondary constipation ( uncontrolled metabolic disease (uncontrolledDM, hypothyroidism), hyperparathyroidism, neurologic disease or use ofanticoagulants, anticholinergics, antihistamines, antipsychotics or opioids)

  • In individuals over 50 years of age, the presence of alarm symptoms (new-onsetconstipation, rectal bleeding, involuntary weight loss, nausea and vomiting, feverand 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 andenterocele stage 3 and above

  • presence of advanced systemic disease (e.g. cardiovascular, respiratory, renal orhepatic diseases)

  • history of abdomino-pelvic or gastrointestinal surgery in the last 6 months

  • presence of open wound, disruption of skin integrity, local tumor, cholestomy orabdominal hernia at the massage site

  • Presence of orthopedic (e.g. lumbopelvic pain, advanced knee joint degeneration) andcardiovascular diseases (e.g. acute coronary syndrome, stage 3-4 heart valvediseases) that may prevent aerobic exercise training

Study Design

Total Participants: 44
Treatment Group(s): 3
Primary Treatment: Abdominal Massage
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
March 15, 2026

Study 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.

Connect with a study center

  • Ceren Gursen

    Ankara, 06100
    Turkey

    Site Not Available

  • Hacettepe University

    Ankara,
    Turkey

    Active - Recruiting

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