Investigation of the Effects of Calisthenic Exercises Performed With Telerehabilitation on Oxygen Consumption, Muscle Oxygenation and Physical Activity in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Physical activity level assessment with multi-sensor activity tracking
研究概览
简要总结
Type 2 diabetes (T2DM) is a metabolic disease characterized by chronic hyperglycemia that occurs as a result of any disorder in insulin secretion or insulin activity. Regular physical activity is important in preventing and managing this disease.
详细描述
Type 2 diabetes causes significant mortality and morbidity, increases healthcare costs, and increases the risk of cardiovascular disease. Due to the rapid increase in the number of individuals with diabetes, preventing and controlling this disease and living with diabetes is important. In patients with T2DM, pulmonary function decrease in relation to glycemic control and disease duration. Decrease in cardiorespiratory fitness can lead to cardiovascular mortality. Cardiovascular mortality increases as exercise capacity decreases. Although the determinants of exercise intolerance in diabetes are not fully understood, a number of abnormalities in pulmonary diffusion capacity, maximum cardiac output, blood oxygen capacity and skeletal muscle properties cause exercise tolerance. Peripheral factors such as skeletal muscles also affect exercise intolerance. Insufficient oxygen use in skeletal muscles is considered one of the causes of exercise intolerance in patients with T2DM. To reduce the cardiovascular mortality rate and risk factors associated with cardiovascular disease, physical activity level is important in patients with T2DM, as in all populations. Maintaining physical activity level plays a protective role against both T2DM and cardiovascular disease. It is important to give this patient group exercise habits. Calisthenic exercise training via telerehabilitation is an advantageous method of gaining exercise habits in the home environment, without requiring any equipment. Concerns such as the benefits of modern life, time saving and cost reduction have made it necessary to develop new rehabilitation approaches. It is thought that calisthenic exercise training with telerehabilitation will be beneficial for Type 2 Diabetes patients. The primary aim of the study is to investigate the effects of calisthenic exercise training via telerehabilitation on exercise capacity, muscle oxygenation and physical activity level in patients with Type 2 Diabetes Mellitus. The secondary aim of the study is to investigate the effects of calisthenic exercise training via telerehabilitation on exercise capacity, dual task performance, respiratory functions, respiratory muscle strength and endurance, peripheral muscle strength, shortness of breath, fatigue, depression, anxiety, sleep and quality of life. .
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T2DM,
- •Aged between 18-65 years,
- •Able to walk and cooperate,
- •Patients who volunteer to participate in the study.
排除标准
- •Body mass index >40 kg/m2,
- •A known lung disease,
- •Serious neurological, neuromuscular, orthopedic, or other diseases affecting physical functions,
- •Cognitive impairment that causes them to have difficulty understanding and following exercise test instructions,
- •Having had any cardiac event or surgery in the last six months,
- •Participated in a planned exercise program within the last three months,
- •Uncontrolled hypertension,
- •An acute pulmonary exacerbation within the last 4 weeks, have an acute upper or lower respiratory tract infection,
- •Presence of diabetes complications such as nephropathy, retinopathy and severe neuropathy,
- •Contraindications for exercise testing and/or exercise training according to the American College of Sports Medicine.
结局指标
主要结局
Physical activity level assessment with multi-sensor activity tracking
时间窗: through study completion, an average of 2 year
A multi-sensor activity monitor will be used to assess the level of physical activity
Oxygen consumption
时间窗: through study completion, an average of 2 year
Maximum exercise capacity will be assessed by symptom-limited cardiopulmonary exercise testing on a treadmill at gradually increasing speed and degree, and oxygen consumption will be measured during the test.
Muscle oxygenation
时间窗: through study completion, an average of 2 year
Before the cardiopulmonary exercise test during and after the tests the muscle oxygenation will be measured by using a near-infrared spectroscopy device.
次要结局
- Respiratory Muscle Endurance(through study completion, an average of 2 year)
- Peripheral muscle strength (%)(through study completion, an average of 2 year)
- Upper extremity functional exercise capacity (percentage of the expected value (%))(through study completion, an average of 2 year)
- Dual task performance(through study completion, an average of 2 year)
- Dyspnea in daily life(through study completion, an average of 2 year)
- Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))(through study completion, an average of 2 year)
- Upper extremity functional exercise capacity(through study completion, an average of 2 year)
- Pulmonary function (Forced expiratory volume in the first second (FEV1))(through study completion, an average of 2 year)
- Pulmonary function (Forced vital capacity (FVC))(through study completion, an average of 2 year)
- Pulmonary function (FEV1 / FVC)(through study completion, an average of 2 year)
- Pulmonary function (Peak flow rate (PEF))(through study completion, an average of 2 year)
- Diabetes symptoms(through study completion, an average of 2 year)
- Daytime Sleepiness(through study completion, an average of 2 year)
- Peripheral muscle strength (N)(through study completion, an average of 2 year)
- Fatigue(through study completion, an average of 2 year)
- Anxiety and Depression(through study completion, an average of 2 year)
- Sleep Quality(through study completion, an average of 2 year)
- Life quality(through study completion, an average of 2 year)
- Dyspnea perception(through study completion, an average of 2 year)
- Respiratory Muscle Strength(through study completion, an average of 2 year)
研究者
Meral Boşnak Güçlü
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation
Gazi University