| CTRI Number |
CTRI/2025/07/091834 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy & Yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Physio-Yogic, Pelvic Floor Exercises and Yoga on Muscle Activation, Circadian Rhythm and Gut Health among Women with Functional Constipation |
|
Scientific Title of Study
|
Comparative Effect of Physio-Yogic, Pelvic Floor Exercises and Yoga on Muscle Activation, Circadian Rhythm and Gut Health among Women with Functional Constipation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himani Kaushik |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna International Institute of Research & Studies |
| Address |
Manav Rachna International Institute of Research & Studies, Sector 43, Surajkund, Delhi Road, Faridabad 121004
Manav Rachna International Institute of Research & Studies, Sector 43, Surajkund, Delhi Road, Faridabad 121004
North
DELHI
121004
India |
| Phone |
8750192942 |
| Fax |
|
| Email |
himanikaushik06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasmine Kaur Chawla |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research & Studies |
| Address |
Manav Rachna International Institute of Research & Studies, Sector 43, Surajkund, Delhi Road, Faridabad 121004
Manav Rachna International Institute of Research & Studies, Sector 43, Surajkund, Delhi Road, Faridabad 121004
North
DELHI
121004
India |
| Phone |
9888263685 |
| Fax |
|
| Email |
jasminekaur.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Himani Kaushik |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna International Institute of Research & Studies |
| Address |
Manav Rachna International Institute of Research & Studies, Sector 43, Surajkund, Delhi Road, Faridabad 121004
Manav Rachna International Institute of Research & Studies, Sector 43, Surajkund, Delhi Road, Faridabad 121004
New Delhi
DELHI
121004
India |
| Phone |
8750192942 |
| Fax |
|
| Email |
himanikaushik06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research & Studies, Sector 43, Surajkund, Delhi Road, Faridabad 121004 |
|
|
Primary Sponsor
|
| Name |
Himani Kaushik |
| Address |
Manav Rachna International Institute of Research & Studies, Sector 43, Surajkund, Delhi Road, Faridabad 121004 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jasmine Kaur Chawla |
Manav Rachna International Institute of Research and Studies |
Q Block, Room no: QF 03, Musculoskeletal lab, Department of Physiotherapy, Manav Rachna International Institute of Research and Studies, Sector-43, Aravalli Hills, 121007 Faridabad, Haryana.
Faridabad
HARYANA |
9888263685
jasminekaur.sahs@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee, MRIIRS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Functional Constipation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Education Program - 8 - Weeks |
| Intervention |
Pelvic Floor Exercises |
8 - Weeks Protocol |
| Intervention |
Physio-Yogic Exercises |
8 - Weeks Protocol |
| Intervention |
Yoga |
8 - Weeks Protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
i. Female 18-40 years of age
ii. Meeting the Criteria of ROME-III for Functional Constipation, along with the Bristol Scale
|
|
| ExclusionCriteria |
| Details |
i. 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.
v. Already participated in physical exercise treatment and is receiving any medication or treatment that has superimposing effects (e.g. Hormonal therapy)
vi. History of taking any medicines such as opioids, steroids, in the last 7 days.
vii. 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
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Muscle Activation
a) Electromyography (surface EMG)
Circadian Rhythm
b) Morningness and Eveningness Questionnaire (MEQ)
Gut Health
c) Patient Assessment Constipation Quality of Life (PAC-QoL)
d) Constipation Severity Score (CSS)
e) Rome III, along with the Bristol Scale
f) Frequency of Bowel movements per week
Other Outcome Measures
g) Kuppuswamy socioeconomic scale (Modified)
h) Kessler Psychological Distress Scale (K10)
i) Food Frequency Quality using serial 24-h recalls (FFQ)
j) IPAQ (SF)
|
Baseline
At 4th week
At 8th week
After 2-months follow-up |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
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