- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07352449
Acute Effects of Abdominal Massage on Arterial Stiffness, Muscle Oxygenation and Exercise Capacity in Constipation
Investigation of the Acute Effects of Classical Abdominal Massage on Arterial Stiffness, Muscle Oxygenation, and Exercise Capacity in Patients With Chronic Constipation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Constipation is a highly prevalent health problem that adversely affects physical, mental, and social well-being, thereby reducing health-related quality of life. In Türkiye, population-based studies indicate that its prevalence ranges widely across communities. Clinically, constipation is described as having fewer than three bowel movements per week or experiencing subjective symptoms such as incomplete evacuation, bloating, abdominal tightness, restlessness, and discomfort despite normal stool frequency. Its pathogenesis is multifactorial and influenced by dietary patterns, genetic predisposition, colonic motility and absorption, as well as behavioral, biological, and pharmacological factors. A sedentary lifestyle and inadequate fluid intake are recognized risk factors. Although various classification systems for constipation exist in the literature, the present study focuses specifically on individuals diagnosed with chronic constipation. Chronic constipation is not a disease in itself but a symptom characterized by reduced defecation frequency, hard stools, straining, and a persistent sense of incomplete evacuation, with its definition varying among individuals.
Physical activity is a lifelong behavior essential for maintaining and improving cardiorespiratory endurance, reducing obesity and related diseases, and promoting longevity. Multiple studies have shown a positive association between walking and bowel motility. Exercise, one of the structured components of physical activity, consists of planned, repetitive body movements aimed at improving one or more components of physical fitness, and has been reported to be negatively associated with chronic constipation in adults. In some populations, daily moderate-intensity exercise has been shown to substantially reduce constipation, although other findings suggest that its benefits may depend on symptom severity or age group. Reduced bowel motility is strongly linked to low levels of physical activity, and individuals with constipation often demonstrate decreased activity levels; consequently, a reduction in exercise capacity is also expected. However, no studies have directly examined exercise capacity in patients with chronic constipation. The current study aims to address this gap by investigating the effect of classical abdominal massage on exercise capacity in individuals with chronic constipation.
Constipation is also associated with cardiovascular events. Alterations in gut microbiota may contribute to atherosclerosis, elevated blood pressure, and cardiovascular complications. With increasing age, constipation frequently coexists with other cardiovascular risk factors. Straining during defecation can raise blood pressure and may precipitate events such as heart failure, arrhythmias, acute coronary syndromes, or even aortic dissection. Chronic constipation may also trigger psychological stress, potentially influencing blood pressure regulation. The Valsalva-like breathing pattern often observed during straining further supports this physiological relationship. Arterial stiffness, a marker of atherosclerosis, occurs due to thickening and loss of elasticity in arterial walls. The mesenteric arteries, which supply the small and large intestines, are anatomically positioned such that colonic displacement-common in constipated individuals-may impose tension on branches such as the superior mesenteric artery. Transverse colon ptosis can alter the anatomical orientation of the colon and its vascular supply, contributing to bowel dysfunction and worsening constipation. To date, no study has examined arterial stiffness in patients with chronic constipation, and the present research seeks to elucidate this relationship and explore the acute effects of classical abdominal massage on arterial stiffness.
Muscle oxygenation reflects oxygen delivery and utilization within target tissues as a consequence of metabolic respiration. As a key indicator of metabolic activity, muscle oxygen saturation (SmO₂) provides insight into muscular performance and the balance between oxygen supply and demand during rest and exercise. Efficient oxygen utilization is crucial for sustaining physical activity, yet no studies have investigated muscle oxygenation in individuals with chronic constipation. This study therefore also aims to determine the acute effects of classical abdominal massage on muscle oxygenation and to clarify the potential relationship between chronic constipation and altered tissue oxygen dynamics.
Quality of life is a multidimensional and highly individualized construct influenced by physical, psychological, social, economic, and cultural factors. Although constipation is not life-threatening, it imposes biological, psychological, sociocultural, and economic burdens that negatively affect an individual's quality of life. The bidirectional communication between the brain and the gastrointestinal system, mediated through neural and hormonal pathways, also involves feedback mechanisms that influence circadian rhythms and sleep regulation. Poor sleep can exacerbate gastrointestinal symptoms, while digestive disorders may disrupt sleep-wake cycles and reduce sleep quality. For this reason, the present study additionally explores the effects of classical abdominal massage on sleep quality and health-related quality of life.
A wide range of pharmacological and non-pharmacological treatments are used in the management of constipation. Due to the potential adverse effects and financial burden associated with laxatives, non-pharmacological approaches have gained notable importance. Abdominal massage is a safe, non-invasive method widely used in both healthy individuals and patients with constipation. Manual pressure applied to the abdominal wall may stimulate gas movement, enhance bowel sounds, increase peristaltic activity, and facilitate mechanical stimulation of digestive organs. Through techniques such as effleurage, petrissage, vibration, and tapotement, abdominal massage can reduce muscle tension, promote local circulation, enhance digestive function, stimulate gastric secretions, increase alertness and peristalsis, relieve constipation, and even reduce elevated blood pressure. The abdominal region's extensive fascial network allows massage to induce mechanical and reflex effects on the intestines by altering intra-abdominal pressure and applying force to the rectum. Physiological responses to massage encompass biomechanical, physiological, neurological, and psychological domains. Previous research has demonstrated the use of abdominal massage as a palliative technique for chronic constipation, fecal incontinence, abdominal muscle tone alterations, and abdominal pain, with no reported adverse effects. However, no prior study has investigated the acute effects of classical abdominal massage on arterial stiffness, muscle oxygenation, and exercise capacity in individuals with chronic constipation. The aim of the present study is to address this gap and provide novel insights into these physiological interactions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey (Türkiye), 06490
- Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Adults aged 18-65 years
- Clinically diagnosed with chronic constipation
- Willing and able to provide informed consent and voluntarily participate in the study
Exclusion Criteria
- Presence of cognitive impairment that may interfere with understanding questionnaire items or performing test instructions
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
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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.
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).
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.
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Other: Control
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.
|
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).
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial stiffness (Aortic systolic pressure (SBP))
Time Frame: First Day
|
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))
Time Frame: First Day
|
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))
Time Frame: First Day
|
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))
Time Frame: First Day
|
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))
Time Frame: First Day
|
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))
Time Frame: First Day
|
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))
Time Frame: First Day
|
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))
Time Frame: First Day
|
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))
Time Frame: First Day
|
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
Time Frame: First Day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise capacity
Time Frame: First day
|
Functional exercise capacity was assessed with 6MWT according to the American Thoracic Society and European Respiratory Society criteria .
|
First day
|
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Assessment of Quality of Life
Time Frame: First Day
|
Quality of life was assessed with the CCQLS.
This self-report scale consists of 28 items and subscales of "worry/anxiety" (11 items), "physical discomfort" (4 items), "psychosocial discomfort" (8 items), and "satisfaction" (5 items).
Each item is scored on a scale of 1 to 5. The total score ranges from 28 to 140, with higher scores indicating greater symptom severity or frequency, depending on the subscale, and worsening quality of life.
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First Day
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Heart rate (HR)
Time Frame: First day
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Heart rate (HR) was continuously monitored using a heart rate monitor during the 6-minute resting period, throughout the test, and during the recovery phase.
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First day
|
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Blood pressure (BP)
Time Frame: First day
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Blood pressure (BP) was measured using a standard sphygmomanometer during the 6-minute resting period and in the recovery phase to assess hemodynamic responses.
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First day
|
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Oxygen saturation (SpO₂)
Time Frame: First day
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Peripheral oxygen saturation (SpO₂) was continuously monitored using pulse oximetry during the 6-minute resting period, throughout the test, and during the recovery phase.
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First day
|
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Respiratory rate (RR)
Time Frame: First day
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Respiratory rate (RR) was assessed manually by counting breaths per minute during the 6-minute resting period, throughout the test, and during the recovery phase.
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First day
|
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Dyspnea
Time Frame: First day
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Perceived dyspnea was evaluated using the modified Borg scale (0-10), where 0 indicates no breathlessness and 10 indicates maximal breathlessness, during the 6-minute resting period, at the end of the test, and during the recovery phase.
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First day
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Perceived exertion - body
Time Frame: First day
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Overall perceived exertion of the body was assessed using the modified Borg scale (0-10), where 0 represents no exertion and 10 represents maximal exertion, at the end of the test and during the recovery phase.
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First day
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Perceived exertion - legs
Time Frame: First day
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Perceived exertion of the legs was evaluated using the modified Borg scale (0-10), where 0 represents no exertion and 10 represents maximal exertion, at the end of the test and during the recovery phase to assess localized muscular fatigue.
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First day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Meral Boşnak Güçlü, Prof, Gazi University
- Principal Investigator: Musa Güneş, PhD, Karabuk University
- Study Chair: Betül YOLERİ, MSc, Gazi University
- Principal Investigator: Ramazan Kozan, MD, Gazi University
- Principal Investigator: Elif Sıla Karaveli, Pt, Gazi University
- Principal Investigator: Merve Bayrak, Pt, Gazi University
- Principal Investigator: Zeyneb Süeda Kaledibi, Pt, Gazi University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gazi2709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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