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临床试验/NCT04643873
NCT04643873已完成不适用

Effects of Physical Activity Counseling and Pilates Exercises on Metabolic Control Variables in Patients With Prediabetes and Type 2 Diabetes:Randomised Controlled Study

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
fasting blood glucose

研究概览

简要总结

The primary aim of our study is to evaluate the effects of physical activity counseling and pilates exercises on metabolic control variables in patients with prediabetes and type 2 diabetes; Its secondary aim is to examine the effects of both practices on physical activity level, exercise capacity and quality of life, and to compare the relationship between those under medical supervision by family doctor.

详细描述

According to the World Health Organization (WHO), diabetes is defined as a disease that occurs when the insulin hormone which is responsible for regulating blood glucose and secreted by the pancreas. It cannot be produced individually or used effectively by the body. It is a chronic disease with high morbidity and mortality and adversely affected by diabetes complications. Purpose in diabetes treatment; control of the individual's blood glucose level, prevention or control of complications. From the moment of diagnosis, healthy lifestyle changes are recommended for metabolic control in individuals with diabetes. Diabetes is classified as type 1, type 2, other specific causes and gestational diabetes according WHO. 90-95% of diabetes cases diagnosed all over the world are type 2 diabetes, 5-10% is type 1 diabetes and 2-3% is other diabetes types.

During exercise, oxygen and glucose input to muscle cells increases and regular physical activity provides metabolic control. Many studies have shown that physical activity has a protective effect on impaired glucose tolerance and prevents the risk of cardiovascular diseases and premature death in patients with type 2 diabetes. However, 60-70% of individuals with type 2 diabetes can not reach their daily physical activity goal and most of them can not maintain their regular exercise program. In order to prevent patients from giving up exercise early, it is important to provide personal counseling at certain periods, to encourage, support and advice during exercises, and to explain the exercises in a way that patients can understand.

In our study, patients with type 2 diabetes will be randomly divided into 3 groups as physical activity counseling and pilates exercise group, only physical activity counseling group, and control followed only with family physician recommendations and follow-up. It is planned to do the pilates exercises for 50 minutes a day, 2 days a week during 12 weeks with physiotherapist. Pilates group patient will make pilates exercise once a week alone. Individual exercise sessions will start with 5-10 minutes of warm-up exercises and end with cool-down exercises in the same time. Overall in the program; stretching exercises in different positions (standing and lying), exercises to increase the flexibility of the trunk muscles, upper extremity movements with and without an exercise ball, strengthening exercises with theraband will be applied. Types of movements to strengthen all abdominal muscles, muscles around the hips, back muscles, muscles in the shoulder girdle (shoulder bridge, corkscrew, roll-up, roll down, clam, side kick, staggered legs, scissors, swimming, swan dive, breast stroke preparation, Abdominal preparation, oblique preparation) will be used alternately in different sessions, from easy to difficult. Pilates exercises will be performed with light and relaxing music.

Within the scope of physical activity, moderate and / or high intensity aerobic exercise recommended by cIntegrating physical activity in primary care practice. The American Journal of Medicine (ACSM) will be recommended 150 minutes in a week. Care will be taken not to take a break for more than 2 days between two exercise days. In addition, strengthening exercises that will maintain or increase muscle strength including large muscle groups at least 3 days a week will be determined in accordance with the patient's current possibilities. Recommendations will be given for possible complications such as hypoglycemia during and after exercise.

During physical activity counseling, considering the current physical and metabolic status of the person, the person-based 5A model of ACSM will be adapted to individuals with diabetes and physical activity consultancy will be provided. The 5A model consists of assess, advise, agree, assist, and arrange subsections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 70 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Having been diagnosed with prediabetes or Type II diabetes at most 10 years ago
  • Not using insulin
  • Being under the age of 70
  • Individuals regulated by glucose control, medication and / or diet
  • Volunteering to exercise at least 3 days a week in the intervention group within the scope of the research
  • Being able to communicate in Turkish written and verbal

排除标准

  • Having uncontrolled hypertension (160/90 mmHg), cardiovascular problem, renal disease, neuropathy, systemic disease that will create contraindications for exercise
  • Body mass index over 35 kg / m²
  • Being a communication problem, not being able to cooperate

结局指标

主要结局

fasting blood glucose

时间窗: up to 12 weeks

A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is normal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes. If it's 126 mg/dL (7 mmol/L) or higher on two separate tests, you have diabetes percentage of body fat, amount of visceral fat, body mass index: amount of muscle mass in the trunk and extremities

HbA1c

时间窗: up to 12 weeks

A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin. Normal: HbA1c below 5.7% Prediabetes: HbA1c between 5.7% and 6.4% Diabetes: HbA1c of 6.5% or higher

HDL

时间窗: up to 12 weeks

HDL (high-density lipoprotein cholesterol) cholesterol: High density lipoprotein cholesterol.60 mg/dL (1.6 mmol/L) or above is desirable

LDL

时间窗: up to 12 weeks

LDL (low-density lipoprotein cholesterol) Adult - \< 130 mg/dL is normal value for LDL. Low-density lipoprotein is a type of lipoprotein that consists of cholesterol (LDL cholesterol, LDL-C) and similar substances with a small amount of protein

total cholesterol

时间窗: up to 12 weeks

Total cholesterol a measure of the total amount of cholesterol in your blood. It includes both low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol. Less than 200 mg/dL is normal

triglyceride values

时间窗: up to 12 weeks

Triglycerides are a type of fat (lipid) found in blood. Normal is less than 150 milligrams per deciliter (mg/dL), or less than 1.7 millimoles per liter (mmol/L)

percentage of body fat

时间窗: up to 12 weeks

Body fat percentage will be calculated with the Jawon X-Contact 350 device

Muscle mass amounts in the trunk and extremities

时间窗: up to 12 weeks

Muscle mass amounts in the trunk and extremities will be calculated with the Jawon X-Contact 350.Muscle mass includes the skeletal muscles, smooth muscles such as cardiac and digestive muscles and the water contained in these muscles

Step number

时间窗: up to 12 weeks

Average one week steps before and after intervention will be calculated with OMRON HJ 109 pedometer

次要结局

  • Short version of IPAQ (International Physical Activity Questionnaire)(up to 12 weeks)
  • SF36 (Short Form 36)(up to 12 weeks)
  • 6 minutes walk test(up to 12 weeks)
  • BMI (body mass index)(up to 12 weeks)
  • amount of visceral fat(up to 12 weeks)
  • Berg Balance Scale(up to 12 weeks)
  • waist circumference(up to 12 weeks)
  • hip circumference(up to 12 weeks)
  • Waist-Hip Circumference Ratio(up to 12 weeks)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

merve şuay üçgül

principal investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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