Acute Effects of Abdominal Massage on Arterial Stiffness, Muscle Oxygenation and Exercise Capacity in Constipation

NCT07352449 | Completed

• 1 other identifier: Gazi2709
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic constipation; arterial stiffness; muscle oxygenation; exercise capacity

Outcome Measures

Primary Outcomes (10)

• Arterial stiffness (Aortic systolic pressure (SBP))

  Aortic systolic pressure (SBP) was assessed noninvasively using the SphygmoCor XCEL system. This device estimates central (aortic) systolic blood pressure through a validated transfer function based on brachial cuff-derived waveforms. Measurements were performed in the supine position after an adequate rest period, in a quiet and temperature-controlled environment, according to the manufacturer's recommendations. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of central hemodynamic parameters, including aortic SBP, in patients with chronic constipation.

  First Day

• Arterial stiffness (Aortic pulse pressure (APP))

  Aortic pulse pressure (APP) was assessed noninvasively using the SphygmoCor XCEL system. APP was calculated as the difference between central aortic systolic pressure and central aortic diastolic pressure derived from brachial cuff-based waveform analysis using a validated transfer function. All measurements were performed with participants in the supine position after an adequate rest period, in a quiet and temperature-controlled environment, in accordance with the manufacturer's guidelines. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of central hemodynamic parameters, including aortic pulse pressure, in patients with chronic constipation.

  First Day

• Arterial stiffness (Augmentation pressure (AP))

  Augmentation pressure (AP) was assessed noninvasively using the SphygmoCor XCEL system. AP was defined as the absolute difference between the second and first systolic peaks of the central aortic pressure waveform, reflecting the contribution of wave reflection to central systolic pressure. Central aortic pressure waveforms were derived from brachial cuff-based measurements using a validated transfer function. All measurements were conducted with participants in the supine position following an adequate rest period, in a quiet and temperature-controlled environment, in accordance with the manufacturer's recommendations. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of augmentation pressure in patients with chronic constipation.

  First Day

• Arterial stiffness (Augmentation index (AIx))

  Augmentation index (AIx) was assessed noninvasively using the SphygmoCor XCEL system. AIx was calculated as the ratio of augmentation pressure to aortic pulse pressure and expressed as a percentage, reflecting the contribution of wave reflection to central arterial stiffness. Central aortic pressure waveforms were obtained from brachial cuff-based measurements using a validated transfer function. All measurements were performed with participants in the supine position after an adequate rest period, in a quiet and temperature-controlled environment, in accordance with the manufacturer's recommendations. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of augmentation index in patients with chronic constipation.

  First Day

• Arterial stiffness (AIx normalized to 75 bpm (AIx@75))

  AIx normalized to a heart rate of 75 beats per minute (AIx@75) was assessed noninvasively using the SphygmoCor XCEL system. AIx@75 was automatically calculated by the device using a validated algorithm that adjusts the augmentation index for heart rate, allowing standardized comparison between individuals. Central aortic pressure waveforms were derived from brachial cuff-based measurements using a validated transfer function. All measurements were performed with participants in the supine position following an adequate rest period, in a quiet and temperature-controlled environment, in accordance with the manufacturer's recommendations. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of AIx@75 in patients with chronic constipation.

  First Day

• Arterial stiffness (Aortic diastolic pressure (DBP))

  Aortic diastolic pressure (DBP) was assessed noninvasively using the SphygmoCor XCEL system. Central aortic diastolic pressure was derived from brachial cuff-based measurements using a validated transfer function applied to the recorded pressure waveforms. All measurements were performed with participants in the supine position after an adequate rest period, in a quiet and temperature-controlled environment, in accordance with the manufacturer's recommendations. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of central aortic diastolic pressure in patients with chronic constipation.

  First Day

• Arterial stiffness (Aortic mean arterial pressure (MAP))

  Aortic mean arterial pressure (MAP) was assessed noninvasively using the SphygmoCor XCEL system. Central aortic MAP was derived from brachial cuff-based measurements using a validated transfer function applied to the recorded pressure waveforms and calculated by the device according to standard hemodynamic principles. All measurements were performed with participants in the supine position after an adequate rest period, in a quiet and temperature-controlled environment, in accordance with the manufacturer's recommendations. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of central aortic mean arterial pressure in patients with chronic constipation.

  First Day

• Arterial stiffness (Aortic heart rate (HR))

  Aortic heart rate (HR) was assessed noninvasively using the SphygmoCor XCEL system. Heart rate was derived from the central aortic pressure waveform obtained through brachial cuff-based measurements using a validated transfer function. All measurements were performed with participants in the supine position after an adequate rest period, in a quiet and temperature-controlled environment, in accordance with the manufacturer's recommendations. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of heart rate in patients with chronic constipation.

  First Day

• Arterial stiffness (Ejection duration (ED))

  Ejection duration (ED) was assessed noninvasively using the SphygmoCor XCEL system. ED was derived from the central aortic pressure waveform and defined as the time interval between the onset of systolic upstroke and the end of systolic ejection, reflecting left ventricular ejection time. Central aortic pressure waveforms were obtained from brachial cuff-based measurements using a validated transfer function. All measurements were performed with participants in the supine position after an adequate rest period, in a quiet and temperature-controlled environment, in accordance with the manufacturer's recommendations. The SphygmoCor XCEL has demonstrated good validity and reliability for the assessment of ejection duration in patients with chronic constipation.

  First Day

• Muscle oxygenation

  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.

  First Day

Secondary Outcomes (9)

• Exercise capacity

  First day

• Assessment of Quality of Life

  First Day

• Heart rate (HR)

  First day

• Blood pressure (BP)

  First day

• Oxygen saturation (SpO₂)

  First day

Study Arms (2)

Intervention

EXPERIMENTAL

All assessments in the study were completed in a single day before and after intervention. Arterial stiffness was assessed using the SphygmoCor XCEL device, exercise capacity using the 6-MWT, muscle oxygenation during the 6MWT using the Moxy® monitor, and quality of life using the Constipation Quality of Life Scale (CCQLS) and the modified Borg scale for defecation difficulty. Patients in the intervention group received a single 15-minute abdominal massage.

Other: Abdominal massage; Device: SphygmoCOR XCEL; Device: Moxy Monitor

Control

OTHER

All assessments in the study were completed in a single day before and after intervention. Arterial stiffness was assessed using the SphygmoCor XCEL device, exercise capacity using the 6-MWT, muscle oxygenation during the 6MWT using the Moxy® monitor, and quality of life using the Constipation Quality of Life Scale (CCQLS) and the modified Borg scale for defecation difficulty. Patients in the control group received no intervention and were allowed to wait 15 minutes.

Device: SphygmoCOR XCEL; Device: Moxy Monitor

Interventions

Abdominal massage OTHER

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.

Intervention

SphygmoCOR XCEL DEVICE

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).

Control; Intervention

Moxy Monitor DEVICE

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.

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• Adults aged 18-65 years
• Clinically diagnosed with chronic constipation
• Willing and able to provide informed consent and voluntarily participate in the study

You may not qualify if:

• Presence of cognitive impairment that may interfere with understanding questionnaire items or performing test instructions
• Pregnancy

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (7)

• Birimoglu Okuyan C, Bilgili N. Effect of abdominal massage on constipation and quality of life in older adults: A randomized controlled trial. Complement Ther Med. 2019 Dec;47:102219. doi: 10.1016/j.ctim.2019.102219. Epub 2019 Oct 16.

  PMID: 31780015 RESULT

• Monteiro ER, Aguilera LM, Rua-Alonso M, Araujo GDS, Correa Neto VG, Bentes CM, Vilaca-Alves J, Reis VM, Ferreira AS, Marchetti PH, da Silva Novaes J. Effect of Manual Massage, Foam Rolling, and Strength Training on Hemodynamic and Autonomic Responses in Adults: A Scoping Review. Healthcare (Basel). 2025 Jun 7;13(12):1371. doi: 10.3390/healthcare13121371.

  PMID: 40565397 RESULT

• Supa'at I, Zakaria Z, Maskon O, Aminuddin A, Nordin NA. Effects of Swedish massage therapy on blood pressure, heart rate, and inflammatory markers in hypertensive women. Evid Based Complement Alternat Med. 2013;2013:171852. doi: 10.1155/2013/171852. Epub 2013 Aug 18.

  PMID: 24023571 RESULT

• Gibbons WJ, Fruchter N, Sloan S, Levy RD. Reference values for a multiple repetition 6-minute walk test in healthy adults older than 20 years. J Cardiopulm Rehabil. 2001 Mar-Apr;21(2):87-93. doi: 10.1097/00008483-200103000-00005.

  PMID: 11314289 RESULT

• Feldmann A, Schmitz R, Erlacher D. Near-infrared spectroscopy-derived muscle oxygen saturation on a 0% to 100% scale: reliability and validity of the Moxy Monitor. J Biomed Opt. 2019 Nov;24(11):1-11. doi: 10.1117/1.JBO.24.11.115001.

  PMID: 31741352 RESULT

• Nakagomi A, Shoji T, Okada S, Ohno Y, Kobayashi Y. Validity of the augmentation index and pulse pressure amplification as determined by the SphygmoCor XCEL device: a comparison with invasive measurements. Hypertens Res. 2018 Jan;41(1):27-32. doi: 10.1038/hr.2017.81. Epub 2017 Oct 5.

  PMID: 28978987 RESULT

• Honkura K, Tomata Y, Sugiyama K, Kaiho Y, Watanabe T, Zhang S, Sugawara Y, Tsuji I. Defecation frequency and cardiovascular disease mortality in Japan: The Ohsaki cohort study. Atherosclerosis. 2016 Mar;246:251-6. doi: 10.1016/j.atherosclerosis.2016.01.007. Epub 2016 Jan 13.

  PMID: 26812003 RESULT

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Betül Yoleri, MSc

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, Prof

  Gazi University

  STUDY DIRECTOR

• Ramazan Kozan, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Musa Güneş, PhD

  Karabük University

  PRINCIPAL INVESTIGATOR

• Elif Sıla Karaveli, Pt

  Gazi University

  PRINCIPAL INVESTIGATOR

• Merve Bayrak, Pt

  Gazi University

  PRINCIPAL INVESTIGATOR

• Zeyneb Süeda Kaledibi, Pt

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: The study included 30 patients diagnosed with chronic constipation. Patients were randomly assigned to either the intervention group (n=15), which received a single 15-minute abdominal massage session, or the control group (n=15), which received no intervention.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 20, 2026
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)