Faculty of Physical Therapy, Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt
NCT Number: NCT07694830
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt
The practical part of the study will be conducted over 8 weeks, with two sessions per week. Measurements will be taken at baseline before the start of the treatment program and after completion of the 8-week intervention.
A- Evaluative procedures will include
B- Treatment procedures All participants in both groups will receive nutritional counselling for overweight management and functional constipation. The nutritional counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) and the British Dietetic Association (BDA).
C- Statistical analysis : Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS), version 25 for Windows. Descriptive statistics will be used to describe the data. Mixed-model ANOVA will be used to determine within-group changes and between-group differences. The level of significance for all statistical tests will be set at p < 0.05.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Baseline and Week 8
Serum cortisol level will be assessed through laboratory investigation. Blood samples will be collected after an 8-12-hour overnight fast.
Time frame: Baseline and week 8
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.
Time frame: Baseline and Week 8
Lipid profile parameters will be assessed through laboratory investigation, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
Time frame: Baseline and week 8
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.
Time frame: Baseline and week 8
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.
Time frame: Baseline and week 8
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.
Contact information is provided by the study sponsor or research team.
Alaa M ElMoatasem, Assistant professor
CONTACT
0 10 06625054 ext. +2
Doaa M Allam, PhD
CONTACT
01003116041 ext. +2
Cairo University
Other
Effects of Core-Based Movement and Nutritional Counselling on Stress, Cortisol, and Lipid Profiles in Overweight Women With Functional Constipation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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