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

Официальное название

Effects of Core-Based Movement and Nutritional Counselling on Stress, Cortisol, and Lipid Profiles in Overweight Women With Functional Constipation

Обзор

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.

Подробное описание

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

1. Laboratory investigations for serum cortisol and lipid profile. Blood samples will be collected after an overnight fasting period of 8-12 hours, and 5 mL of venous blood will be drawn from each participant. 2. Stool form and consistency will be assessed using the Bristol Stool Form Scale, and participants will be instructed to record their bowel movements and stool consistency. 3. Perceived stress will be assessed using the Perceived Stress Scale. 4. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. 5. Health-related quality of life will be assessed using the 12-Item Short Form Health Survey.

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).

1. Participants in Group A, the study group, will participate in an 8-week core stability-based movement program, two sessions per week, for a total of 16 sessions. They will also receive guideline-based nutritional counselling. Each exercise session will include 5 minutes of warm-up exercises before the core stability-based movement program and 5 minutes of cool-down stretching exercises after the session to ensure participant safety. 2. Participants in Group B, the control group, will receive guideline-based nutritional counselling only for 8 weeks. The counselling will be based on guidance provided by NICE for overweight management and BDA for dietary management of functional constipation.

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.

Вмешательства

• Поведенческое Guideline-Based Nutritional Counselling
  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
• Поведенческое Core-Based Movement Exercise Program
  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 counse

Первичные конечные точки

• Change in Serum Cortisol Level [Срок оценки: Baseline and Week 8]
• Change in Perceived Stress Score [Срок оценки: Baseline and week 8]
• Change in Lipid Profile Parameters [Срок оценки: Baseline and Week 8]

Вторичные конечные точки (3)

• Change in Stool Form and Consistency [Срок оценки: Baseline and week 8]
• Change in Sleep Quality [Срок оценки: Baseline and week 8]
• Change in Health-Related Quality of Life [Срок оценки: Baseline and week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy, Kafrelsheikh University — Kafr ash Shaykh

Идентификаторы

NCT: NCT07694830 · FPTBSUREC/0513/14526

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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