跳至主要内容
临床试验/CTRI/2025/07/091834
CTRI/2025/07/091834尚未招募不适用

Comparative Effect of Physio-Yogic, Pelvic Floor Exercises and Yoga on Muscle Activation, Circadian Rhythm and Gut Health among Women with Functional Constipation

Himani Kaushik1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Muscle Activation

研究概览

简要总结

Functional Constipation or idiopathic (FC) is a primary type of chronic constipation; it is a functional bowel disorder or disorder of the gut-brain interaction of multi-factorial pathophysiology. The patient exhibits challenging, infrequent, or incomplete bowel movements (BMs) without fulfilling the diagnostic criteria for irritable bowel syndrome. Overall, FC has a high prevalence of 45% worldwide in adults. In India reported a prevalence of 75.6% for functional constipation was reported. Functional constipation has a considerable impact on the personal, healthcare, and social dimensions of the patient who suffers, significantly diminishing their quality of life. The severity of FC is influenced not only by bowel-related symptoms but also by a range of biopsychosocial factors, which include the presence of gastrointestinal and extraintestinal symptoms, grade of symptom involvement, and variations in individual perceptions and behaviours. The global prevalence of FC is notably higher among women and the elderly, with associations identified between its occurrence and factors such as age, increased body mass index (BMI), lower socio-economic status, and educational levels. These factors may be connected to dietary and lifestyle choices, decreased mobility, or low levels of self-reported physical activity.  This condition exhibits a varied and complex symptomatology that can significantly reduce overall life satisfaction. Its multifaceted pathophysiology adds layers of complexity to both understanding and treating the condition. The management of FC demands a clinician with expertise in diagnosis and addressing various motor coordination and musculoskeletal impairments. Therefore, this study aims to evaluate and compare the effectiveness of physio-yogic exercises, pelvic floor exercises and yoga on muscle activation, circadian rhythm and gut health among women with functional constipation.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Female 18-40 years of age ii.
  • Meeting the Criteria of ROME-III for Functional Constipation, along with the Bristol Scale.

排除标准

  • Pregnant or Lactating Female (History of pregnancy or lactation in the last 1 year or with complications) ii.
  • History of any abdominal or other surgeries, such as hysterectomy, ostomy iii.
  • Have any history of trauma, cardiovascular, metabolic, psychiatric, musculoskeletal, neurological, cancer, renal or respiratory disorders, history of any musculoskeletal injury (in the last 2 years), and systemic illness iv.
  • Diagnosed cases of anal stenosis or atresis, hemorrhoids, anal fissure, anal fistula, anteriorly displaced anus, imperforate anus, obstructing tumors, malignancies, and anal stricture.
  • Already participated in physical exercise treatment and is receiving any medication or treatment that has superimposing effects (e.g. Hormonal therapy) vi.
  • History of PFD, PCOS, PCOD, prolapse: Ovarian, Uterine or Rectal, Bladder & Bowel incontinence, urinary tract infection viii.
  • Facing pain and discomfort during testing or the study protocol ix.
  • Obese women associated with any Digestive, gastrointestinal and abdominal surgical complications will be excluded.

结局指标

主要结局

Muscle Activation

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

a) Electromyography (surface EMG)

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

Circadian Rhythm

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

b) Morningness and Eveningness Questionnaire (MEQ)

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

Gut Health

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

c) Patient Assessment Constipation Quality of Life (PAC-QoL)

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

d) Constipation Severity Score (CSS)

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

e) Rome III, along with the Bristol Scale

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

f) Frequency of Bowel movements per week

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

Other Outcome Measures

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

g) Kuppuswamy socioeconomic scale (Modified)

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

h) Kessler Psychological Distress Scale (K10)

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

i) Food Frequency Quality using serial 24-h recalls (FFQ)

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

j) IPAQ (SF)

时间窗: Baseline | At 4th week | At 8th week | After 2-months follow-up

次要结局

  • NA(NA)

研究者

发起方
Himani Kaushik
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Himani Kaushik

Manav Rachna International Institute of Research & Studies

研究点 (1)

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