Clinical trial

Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation

Opening soon · Not applicable · 1 countries · Registry ID NCT07694830

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years
SexFemale
Healthy volunteersNot accepted
ConditionFunctional Constipation

Full registry criteria

Inclusion Criteria: * 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. * Willingness to follow the nutritional counselling program and study procedures. Exclusion Criteria: * 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. * Participants with serious cardiovascular, respiratory, renal, hepatic, hematological, neurological, or psychiatric disorders will be excluded. * Participants with a history or current evidence of alcohol abuse within the previous year will be excluded. * Participants currently engaged in an intense workout regimen will be excluded. * Participants with a musculoskeletal disability that may interfere with exercise applicability, such as cervical or lumbar radiculopathy, will be excluded.

Treatments and study arms

Guideline-Based Nutritional Counselling

Behavioral

Participants 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

Behavioral

A 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

Primary outcomes

Change in Serum Cortisol LevelBaseline and Week 8

Serum cortisol level will be assessed through laboratory investigation. Blood samples will be collected after an 8-12-hour overnight fast.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Faculty of Physical Therapy, Kafrelsheikh University🇪🇬 Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt
Doaa M Allam, PhDContact