Acute Effects of Abdominal Massage on Arterial Stiffness, Muscle Oxygenation and Exercise Capacity in Constipation
NCT07352449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-01-20
Summary
Constipation is defined as having bowel movements fewer than three times per week or experiencing subjective complaints such as a sensation of incomplete evacuation, abdominal bloating, tightness, restlessness, or discomfort despite normal bowel frequency, while chronic constipation is not a disease but a symptom characterized by decreased defecation frequency, hard stools, straining, and a persistent feeling of incomplete evacuation, with its definition varying among individuals. The aim of the present study is to investigate the acute effects of a single session of classical abdominal massage on arterial stiffness, muscle oxygenation, exercise capacity, quality of life, and sleep quality in individuals with chronic constipation. At least 30 participants diagnosed with chronic constipation will be included and randomly allocated into an intervention group or a placebo group. In both groups, arterial stiffness, muscle oxygenation, exercise capacity, constipation-related quality of life, and sleep quality will be assessed. In the intervention group, all assessments will be conducted immediately before and after the massage session, whereas in the placebo group, assessments will be performed before and after a waiting period equivalent to the duration of the massage. Normality of the variables will be examined using the Shapiro-Wilk test, histograms, and detrended plots. For between-group comparisons at baseline, independent samples t-tests will be used for normally distributed variables and Mann-Whitney U tests for non-normally distributed variables, while categorical data will be compared using chi-square tests. Post-hoc comparisons will be conducted using Bonferroni-adjusted procedures, and the level of statistical significance will be set at p \< 0.05.
Conditions
- Constipation
- Arterial Stiffness
- Muscle Oxygenation
Interventions
- OTHER
-
Abdominal massage
The intervention group received an abdominal massage performed by the researcher. During the massage, participants were placed in a supine position. The practitioner was positioned on the patient's left side, and all sessions were conducted by the same researcher to standardize the practice. A pillow was placed under the head, and the knees were slightly flexed if comfortable. The massage was performed clockwise, following the anatomical location of the intestines, on the abdominal wall. The duration of the massage was 15 minutes. The massage was initiated in the left lower quadrant of the sigmoid colon and continued throughout the entire abdominal region. Four basic manipulative movements were used in the intervention: superficial effleurage, deep effleurage, petrissage, and vibration. The treatment began with superficial petrissage (stroking) to relax the wall. Deep effleurage and petrissage maneuvers were then performed, and finally, the massage was concluded with vibration.
- DEVICE
-
SphygmoCOR XCEL
Arterial stiffness was assessed noninvasively with the SphygmoCor XCEL device, which has good validity and reliability in patients with chronic constipation . The device measured aortic systolic pressure (SBP), aortic pulse pressure (APP), augmentation pressure (AP), augmentation index (AIx), AIx normalized to 75 bpm (AIx@75), aortic diastolic pressure (DBP), aortic mean arterial pressure (MAP), aortic heart rate (HR) and ejection duration (ED).
- DEVICE
-
Moxy Monitor
Muscle oxygenation was measured using the "Moxy®" monitor (Moxy, Fortiori Design LLC, Minnesota, USA). The device was applied unilaterally to the dominant quadriceps femoris muscle during 6MWT.
Sponsors & Collaborators
-
Gazi University
lead OTHER
Principal Investigators
-
Betül Yoleri, MSc · Gazi University
-
Meral Boşnak Güçlü, Prof · Gazi University
-
Ramazan Kozan, MD · Gazi University
-
Musa Güneş, PhD · Karabük University
-
Elif Sıla Karaveli, Pt · Gazi University
-
Merve Bayrak, Pt · Gazi University
-
Zeyneb Süeda Kaledibi, Pt · Gazi University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2025-06-01
- Completion
- 2025-07-01
Countries
- Turkey (Türkiye)
Study Locations
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