About this trial
This study will investigate the effect of core-based movement and nutritional counselling on stress, serum cortisol, and lipid profile in overweight women with functional constipation.
Sixty overweight women with functional constipation will be randomly assigned into two equal groups. The study group will include 30 participants who will receive a core-based movement exercise program for 8 weeks, two sessions per week, in addition to guideline-based nutritional counselling. The control group will include 30 participants who will receive guideline-based nutritional counselling only for 8 weeks.
The outcomes will include perceived stress, serum cortisol level, lipid profile, stool form, sleep quality, and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants diagnosed with functional constipation according to Rome IV diagnostic criteria.
Age between 18 and 45 years.
Body mass index between 25 and 29.9 kg/m².
Ability to participate safely in the core-based movement exercise program.
Disqualifiers
Participants will be excluded if they have any organic gastrointestinal disorder or any disease that may affect gastrointestinal transit or colonic function.
Participants with inflammatory bowel disease, concurrent infectious enteritis, malignant tumors, or a history of gastrointestinal surgery, including resection of the stomach, small intestine, or large intestine, will be excluded.
Participants receiving steroids, antibiotics, immunosuppressive medications, or routinely using laxatives will be excluded.
Participants with hyperthyroidism, hypothyroidism, or other endocrine or metabolic disorders that may affect gastrointestinal function will be excluded.
Trial design
Parallel
Treatments tested in this trial
Guideline-Based Nutritional Counselling
BehavioralParticipants will receive guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized healthy eating advice, regular meal timing, avoidance of very large or very small meals, adequate hydration, gradual increase of dietary fiber according to tolerance, and encouragement of fiber-rich foods such as vegetables, fruits, whole grains. Participants will also be advised to limit fried foods, processed foods, high-fat foods, excess caffeine, fizzy drinks, refined carbohydrates, and added sugars.
Core-Based Movement Exercise Program
BehavioralA core-based movement exercise program will include Swan, one leg up-down, leg circles, single-leg stretch, Saw, side kicks, The Hundred, pelvic lift on the ball, sit-ups with the ball, and stretching on the ball. During the first month, sessions 1-8, participants will perform 1 set of 8 repetitions. During the second month, sessions 9-16, participants will perform 2 sets of 10 repetitions. Guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized
Treatment groups
Trial outcomes
Primary outcomes
Change in Serum Cortisol Level
Serum cortisol level will be assessed through laboratory investigation. Blood samples will be collected after an 8-12-hour overnight fast.
Change in Perceived Stress Score
Perceived stress will be assessed using the Perceived Stress Scale-10. The total score ranges from 0 to 40, with higher scores indicating higher perceived stress and a worse outcome.
Change in Lipid Profile Parameters
Lipid profile parameters will be assessed through laboratory investigation, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
Secondary outcomes
Change in Stool Form and Consistency
Stool form and consistency will be assessed using the Bristol Stool Form Scale. The scale ranges from Type 1 to Type 7, where Types 1-2 indicate separate hard lumps/constipation, Types 3-4 generally indicate normal stool form, and Types 6-7 indicate watery stool/diarrhea.
Change in Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality and a worse outcome.
Change in Health-Related Quality of Life
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey. The Physical Component Summary and Mental Component Summary scores are norm-based, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better health-related quality of life.
Sponsors and contacts
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Cairo University
Lead sponsor
Kafrelsheikh University
Sponsor institution
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