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临床试验/NCT03106857
NCT03106857已完成不适用

A Proposed Physical Activity and Diet Control to Manage Constipation in Middle Age Obese Women

Ahlia University2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2015年12月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Sayed Tantawy

Associate Professor

Ahlia University

研究点 (2)

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