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临床试验/NCT05251597
NCT05251597Unknown不适用

Comparison of the Effects of Green Exercise Programs Including Resistance Exercises and Aerobic Exercises on Metabolic Syndrome Parameters in Elderly Individuals

Istanbul Medeniyet University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
physical activity level

研究概览

简要总结

The aim of this study is to compare the effects of exercise programs that only aerobic exercise and combination aerobic exercise and resistance exercises on the metabolic syndrome parameters in the green exercise concept.

详细描述

One hundred twenty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into three groups as aerobic, aerobic and resistance and control group. While a group will receive only aerobic exercise, the other group group will receive both aerobic and resistance exercises and one of the group will receive no exercise. Exercises will be held in an open and green area. At the beginning of the treatment and at the end of the twelfth week Hemoglobin A1c (HbA1c), Triglyceride, Hdl cholesterol, Ldl cholesterol, total cholesterol and blood glucose will be evaluated.

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
Single (Participant)

盲法说明

None (Open Label)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •people aged over 65 years
  • •Be fit to participate in exercise program after the first cardiac examination by the physician
  • •Individuals whose blood lipids, Hg a1c and glucose values were checked within 3 months
  • •According to the International Physical Activity Assessment Questionnaire, those who are physically inactive
  • •Having a score above 24 in the Minimental Test

排除标准

  • •Having neuromuscular disease
  • •Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
  • •Having an orthopedic disease that interferes with walking
  • •Having a score below 24 in the Minimental Test

研究组 & 干预措施

green exercise group-1 (aerobic)

Experimental

Forty participants who meet the inclusion criteria will first be given warm-up exercises for 10 minutes, then walking at a moderate intensity (65% of heart rate) for 40 minutes and then stretching exercises for 5 minutes

干预措施: green exercise with aerobic exercise (Other)

green exercise group-2 (aerobic+resistance)

Experimental

For 40 participants who met the inclusion criteria, first 10 minutes of warm-up exercises, then 20 minutes of moderate-intensity (65% of heart rate) walking, followed by 10 minutes of low-intensity (50% of the maximum repetitions) and 10 minutes of high-intensity (80% of the maximum repetitions) resistance exercises will be applied in the presence of a physiotherapist. resistance exercises; shoulder flexors and abductors, elbow flexors and extensors, hip flexors and extensors, knee flexors and extensors, hip abductor muscle group will be performed. At the end of each session, 5 minutes of stretching exercises will also be applied.

干预措施: green exercise with aerobic exercise (Other)

Control group

No Intervention

The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study.

结局指标

主要结局

physical activity level

时间窗: Change from baseline physical activity level at week 12.

physical activity level will be evaulated with international physical activity questionnairre (IPAQ). The questionnaire is based on calculating the MET (metabolic equivalent) value spent by evaluating at least 10 minutes of physical activity in the last seven days in terms of frequency, duration (minutes) and intensity. According to this questionnaire, physical activity level is categorized into 4 classes: inactive, not active enough, active, very active.

hemoglobin A1c

时间窗: Change from baseline hemoglobin A1c at week 12.

After 12-14 hr of fasting, a 10 cc blood sample will be collected from each participant. HbA1c will be measured using the Chromatography method with a com-mercial kit .

blood pressure

时间窗: Change from baseline blood pressure at week 12.

Systolic and diastolic blood pressure will be measured using a standard semi-automatic sphygmomanometer.

lipid profile

时间窗: Change from baseline lipid profile at week 12.

HDL cholesterol, LDL cholesterol, total cholesterol and triglyceride serum levels will be measured to evaluate the lipid profile.HDL cholesterol, LDL cholesterol, total cholesterol and triglyceride will be assessed using enzymatic colorimetry with commercial kits.

fasting blood glucose

时间窗: Change from baseline fasting blood glucose at week 12.

After 12-14 hr of fasting, a 10 cc blood sample will be collected from each participant. Fasting blood samples from the antecubital vein will be collected by vacuum tubes. For biochemical analysis, Fasting blood glucose will be assessed with a commercial kit.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emel Mete

research assistant

Istanbul Medeniyet University

研究点 (2)

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