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临床试验/NCT07352449
NCT07352449已完成不适用

Investigation of the Acute Effects of Classical Abdominal Massage on Arterial Stiffness, Muscle Oxygenation, and Exercise Capacity in Patients With Chronic Constipation

Gazi University0 个研究点目标入组 30 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meral Boşnak Güçlü

Prof. Dr.

Gazi University

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