Effects of Core-Based Movement and Nutritional Counselling on Stress, Cortisol, and Lipid Profiles in Overweight Women With Functional Constipation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Serum Cortisol Level
研究概览
简要总结
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.
详细描述
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
- 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.
- 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.
- Perceived stress will be assessed using the Perceived Stress Scale.
- Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
- 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).
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nutritional Counselling Only
Each participant in this group will receive NICE- and BDA guideline-based nutritional counselling only for overweight management and functional constipation for 8 weeks.
干预措施: Guideline-Based Nutritional Counselling (Behavioral)
Core-Based Movement and Nutritional Counselling
Participants in this group will receive an 8-week core-based movement exercise program, two sessions per week, in addition to NICE- and BDA guideline-based nutritional counselling for overweight management and functional constipation.
干预措施: Guideline-Based Nutritional Counselling (Behavioral)
Core-Based Movement and Nutritional Counselling
Participants in this group will receive an 8-week core-based movement exercise program, two sessions per week, in addition to NICE- and BDA guideline-based nutritional counselling for overweight management and functional constipation.
干预措施: Core-Based Movement Exercise Program (Behavioral)
结局指标
主要结局
Change in Serum Cortisol Level
时间窗: 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.
次要结局
- Change in Sleep Quality(Baseline and week 8)
- Change in Health-Related Quality of Life(Baseline and week 8)
- Change in Lipid Profile Parameters(baseline and week 8)
- Change in Perceived Stress Score(Time Frame: Baseline and week 8)
- Change in stool form , consistency, and frequency(Baseline and week 8)
研究者
Doaa Mohammed Mahmoud Allam
Lecturer
Kafrelsheikh University