A Proposed Physical Activity and Diet Control to Manage Constipation in Middle Age Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Physical activity and constipation relationship
研究概览
简要总结
In total, 125 women aged between 20 and 40 years were recruited in this study. Participants were considered eligible when they met the inclusion criteria of being diagnosed with functional constipation, as defined by the Rome Foundation. The study was a randomized controlled trial carried out at Cairo University Hospital.Patients whose BMI exceeded 30 kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation.
详细描述
In total, 125 women aged between 20 and 40 years were recruited in this study. Participants were considered eligible when they met the inclusion criteria of being diagnosed with functional constipation, as defined by the Rome Foundation. The study was a randomized controlled trial carried out at Cairo University Hospital.
Patients whose BMI exceeded 30 kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation, as follows: (1) Suffered from any 2 or more of the following symptoms in the past 12 weeks (not necessarily consecutive), with the onset of symptoms at least 6 months prior to diagnosis: a) straining during at least 25% of defecations, b) lumpy or hard stools in at least 25% of defecations, c) sensation of incomplete evacuation for at least 25% of defecations, d) sensation of anorectal obstruction/blockage for at least 25% of defecations, e) requirement of manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor muscles), and f) fewer than 3 defecations per week; (2) Loose stools rarely occurred without the use of laxatives; (3) Insufficient criteria for irritable bowel syndrome; and (4) Women were sedentary (less than 1 hour/week of physical activity), with no evidence of participation in diet control/weight reduction programs within the last 6 months.
Patients with metabolic, endocrine, and neurologic constipation; current or past smokers; those with any orthopedic limitation; and those with congenital megacolon, pseudo-obstruction, and anorectal disorders were excluded from the study. Patients suffering from constipation due to drugs, disabled patients, and those who had undergone any abdominal surgery during the intervention or those who failed to complete the study protocol were also excluded. All participants provided a written informed consent before enrolling in the study.
Study design and intervention:
Participants were randomly divided into 2 groups. Group A included 62 women who were following a suggested protocol of physical activity and a low caloric diet in addition to the routine standard care for constipation. The low caloric diet allowed 1000-1200 kcal/day, divided as follows: 50%-60% carbohydrates, 20% protein, <30% total fat, and 18 g of fiber /1000 Kcal. The diet plans were revised every 2 weeks and the diet was modified while ensuring that it was within the allowed caloric value, in addition to the routine standard care for constipation. Group B included 63 patients who received only the standard medical care for constipation and a low caloric diet as in Group A. Patients in both groups followed their program for 12 weeks.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients whose BMI exceeded 30 kg/m2 were included.
- •In addition, they fulfilled the ROM criteria of constipation, as follows:
- •Suffered from any 2 or more of the following symptoms in the past 12 weeks (not necessarily consecutive), with the onset of symptoms at least 6 months prior to diagnosis:
- •straining during at least 25% of defecations,
- •lumpy or hard stools in at least 25% of defecations,
- •sensation of incomplete evacuation for at least 25% of defecations,
- •sensation of anorectal obstruction/blockage for at least 25% of defecations,
- •requirement of manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor muscles), and
- •fewer than 3 defecations per week;
- •Loose stools rarely occurred without the use of laxatives;
- •Insufficient criteria for irritable bowel syndrome; and
- •Women were sedentary (less than 1 hour/week of physical activity), with no evidence of participation in diet control/weight reduction programs within the last 6 months.
排除标准
- •Patients with metabolic, endocrine, and neurologic constipation;
- •current or past smokers;
- •those with any orthopedic limitation; and
- •those with congenital megacolon, pseudo-obstruction, and anorectal disorders were excluded from the study.
- •Patients suffering from constipation due to drugs, disabled patients, and those who had undergone any abdominal surgery during the intervention or those who failed to complete the study protocol were also excluded.
结局指标
主要结局
Physical activity and constipation relationship
时间窗: 11 months
次要结局
未报告次要终点
研究者
Dr Sayed Tantawy
Associate Professor
Ahlia University
