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临床试验/NCT07002970
NCT07002970已完成不适用

Combined Effect of Aerobic Exercise and Mediterranean Diet on Inflammatory Markers and Quality of Life in Obese Patients

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Short Form Quality of Life Questionnaire (SF-36)

研究概览

简要总结

All study group patients performed aerobic exercise on a treadmill. approved by the American College of Sports Medicine.

Both groups received a Mediterranean diet for 12 weeks tailored according to patients' caloric needs

详细描述

All study group patients performed aerobic exercise on a treadmill approved by the American College of Sports Medicine. The program started with a warming-up phase through walking on a treadmill for 3-5 minutes at a slow speed. Then, 10-30 minutes of aerobic exercise training with moderate intensity (60-70% of maximum heart rate) and 10 minutes of cooling down with low speed and without inclination. Participants had 3 sessions/week for 3 months with close supervision of a physical therapist.

Both groups received a Mediterranean diet for 12 weeks tailored to patients' caloric needs. They received instructions about the consumption of olive oil as added lipid, the consumption of nuts and olives as snacks, daily high consumption of vegetables, fruits, and whole grains, dairy products, bi-weekly consumption of legumes, bi-weekly consumption of fish, and monthly consumption of meat. The main beneficial components of the Mediterranean diet are monounsaturated fats such as oleic acid in olive oil, polyunsaturated fats such as omega-3, high amounts of flavonoids and antioxidants found in fruits and vegetables, and high amounts of fiber found mainly in foods with a low glycemic index

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Obese patients with BMI ranged from 30-39.9 kg/m
  • •Their age was from 35 to 45 years old.
  • •Both genders.
  • •Stable vital signs (blood pressure, respiratory rate and temperature)
  • •Abdominal obesity measurements according to American heart association)
  • •Obese patients have one or more abnormal value of lipids profile.
  • •All patients with sedentary life style.
  • •All patients had insulin resistance

排除标准

  • •Rheumatic, neurologic, cardiovascular, respiratory, renal, lung problems, malignant tumors, and undiagnosed fever, which would prevent them from participating in aerobic exercises.
  • •Knee injury or knee surgery during the past six month or having a history of joint replacement or fracture or hereditary or acquired musculoskeletal disorders in lower limb.
  • •Major vision disorders.
  • •Drugs that would affect metabolism or balance.
  • •Assistive devices for walking.
  • •Pregnancy or breast feeding, and post-partum 12 months.
  • •Abdominal or rectal anus surgery.

研究组 & 干预措施

study group

Experimental

aerobic exercise program and Mediterranean diet

干预措施: aerobic exercise program (Other)

study group

Experimental

aerobic exercise program and Mediterranean diet

干预措施: Mediterranean diet (Other)

control group

Active Comparator

Mediterranean diet

干预措施: Mediterranean diet (Other)

结局指标

主要结局

Short Form Quality of Life Questionnaire (SF-36)

时间窗: 12 weeks

To measure the health related quality of life (HRQOL)in obese patient. SF-36 (version 2.0) is a 36-item measure of generic HRQOL in which 35 questions are transformed into eight dimensions; physical functioning, role limitation to physical problems, bodily pain, general health, vitality, social functioning, role limitations to emotional problems, and mental health Scores on all eight dimensions range from zero to 100, where higher scores represent better HRQOL

次要结局

  • Laboratory Measurements(12 weeks)
  • Blood Pressure Measures(12 weeks)
  • body weight(12 weeks)
  • height(12 weeks)
  • waist and hip circumferences(12 weeks)

研究者

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

Mai Salah

principal investigator

Cairo University

研究点 (1)

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