Effects of an Eight-week Diet Versus Diet Plus Aerobic and Resistant Exercise Program on Postural Control, Musculoskeletal Disorders, Functional Capacity, and Sleep in Overweight Women: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of postural control by Biodex Balance System
研究概览
简要总结
Adult women aged 18-50 years and overweight (preobese) with a BMI of 25-30 kg/m2 will be included in the study. Participants will participate in an eight-week diet and diet plus aerobic and resistance exercise program. Patients will be referred from the Nutrition and Diet Polyclinic of Bezmialem Vakıf University to this study, which will be conducted to investigate the effects of exercise program on postural control, musculoskeletal system disorders, functional capacity, and sleep.
详细描述
Subjects who accepted to participate in the study will be randomized and divided into two groups as study and control groups. A computer-based randomization program (random.org) will be used to determine the cases to be assigned to the study and control groups. 2 numbers consisting of 12 numbers will be determined by random selection from the numbers between 1 and 24. The first of these number sequences will be considered as the study group and the second as the control group. Each patient included in the study will be asked to draw one of the sealed envelopes in which the numbers 1 to 24 are written. The case will be assigned to the study or control group according to the number sequence in which the drawn number is included. While the women in the study group are expected to perform regular walking with a diet for eight weeks and a 3-day aerobic and resistance exercise program per week, the subjects in the control group will be followed up with diet and regular walking. Initially, participants will be educated on healthy eating habits through one-on-one dietitian consultation. A personalized calorie-restricting nutrition program will be given. According to this program, the daily energy intake of the individual will be reduced to provide 0.5-1.0 kg of body weight loss per week.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI between 25-29.9kg/m2
- •Being between the ages of 18-50
- •Agreeing to participate voluntarily in the study
排除标准
- •Pregnancy
- •Presence of systemic disease that will prevent participation in an aerobic exercise program
- •Presence of conditions such as pain or surgery that will prevent participation in an aerobic exercise program
- •Participating in a regular exercise program within the last 1 year
研究组 & 干预措施
Study group
The women in the study group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program for eight weeks and aerobic and resistance exercise program 3 days a week.
干预措施: Aerobic and resistance exercises (Other)
Study group
The women in the study group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program for eight weeks and aerobic and resistance exercise program 3 days a week.
干预措施: Diet program (Dietary Supplement)
Study group
The women in the study group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program for eight weeks and aerobic and resistance exercise program 3 days a week.
干预措施: Regular walking program (Other)
Control group
The women in the control group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program.
干预措施: Diet program (Dietary Supplement)
Control group
The women in the control group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program.
干预措施: Regular walking program (Other)
结局指标
主要结局
Evaluation of postural control by Biodex Balance System
时间窗: Change between baseline and 8-week scores of Biodex Balance System.
Postural control evaluation will be performed with "Biodex Balance System®" (Biodex Medical Systems, Shirley, New York, USA) which is a valid and reliable equipment. Three tests will be performed with the device: postural stability test, stability limits test, and modified clinical test of sensory integration of balance. During the evaluation, three measurements of 20 seconds, 10 seconds intervals between each measurement, will be performed in all tests. Higher control over balance is indicated by a lower score of overall, anterior/posterior, and medial/lateral stability index in the PS test. However, a higher score indicates a lower level of postural control in stability limits and modified clinical test of sensory integration of balance tests.
次要结局
- Evaluation of functional capacity by 6 minute walk test(Change between baseline and 8-week scores of 6 Minute Walk Test.)
- Evaluation of sleep quality by Pittsburgh Sleep Quality Index(Change between baseline and 8-week scores of Pittsburgh Sleep Quality Index.)
- Evaluation of musculoskeletal by Extended Nordic Musculoskeletal Questionnaire(Change between baseline and 8-week scores of Extended Nordic Musculoskeletal Questionnaire.)
研究者
Deniz Tuncer
Assistant professor
Bezmialem Vakif University