Clinical trial NCT06222086: The Effects of Calisthenic Exercise Training in Patients With Type 2 Diabetes
Official title: Investigation of the Effects of Calisthenic Exercises Performed With Telerehabilitation on Oxygen Consumption, Muscle Oxygenation and Physical Activity in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Calisthenic Exercise Training
Oxygen consumption
Muscle oxygen
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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. .

Eligibility criteria: Inclusion Criteria:

* Diagnosed with T2DM,
* Aged between 18-65 years,
* Able to walk and cooperate,
* Patients who volunteer to participate in the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Oxygen consumption
timeFrame: through study completion, an average of 2 year
measure: Muscle oxygenation
timeFrame: through study completion, an average of 2 year
measure: Muscle oxygenation
timeFrame: through study completion, an average of 2 year
measure: Physical activity level assessment with multi-sensor activity tracking
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Upper extremity functional exercise capacity
timeFrame: through study completion, an average of 2 year
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: through study completion, an average of 2 year
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: through study completion, an average of 2 year
measure: Pulmonary function (FEV1 / FVC)
timeFrame: through study completion, an average of 2 year
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: through study completion, an average of 2 year
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: through study completion, an average of 2 year
measure: Dual task performance
timeFrame: through study completion, an average of 2 year
measure: Respiratory Muscle Strength
timeFrame: through study completion, an average of 2 year
measure: Respiratory Muscle Strength
timeFrame: through study completion, an average of 2 year
measure: Respiratory Muscle Endurance
timeFrame: through study completion, an average of 2 year
measure: Peripheral muscle strength (N)
timeFrame: through study completion, an average of 2 year
measure: Dyspnea in daily life
timeFrame: through study completion, an average of 2 year
measure: Fatigue
timeFrame: through study completion, an average of 2 year
measure: Anxiety and Depression
timeFrame: through study completion, an average of 2 year
measure: Daytime Sleepiness
timeFrame: through study completion, an average of 2 year
measure: Sleep Quality
timeFrame: through study completion, an average of 2 year
measure: Life quality
timeFrame: through study completion, an average of 2 year
measure: Diabetes symptoms
timeFrame: through study completion, an average of 2 year
measure: Dyspnea perception
timeFrame: through study completion, an average of 2 year
measure: Peripheral muscle strength (%)
timeFrame: through study completion, an average of 2 year
measure: Upper extremity functional exercise capacity (percentage of the expected value (%))
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Ayşenur SARISAKALOĞLU, MSc
role: STUDY_CHAIR
affiliation: Gazi University
name: Fidan YILMAZ, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Füsun BALOŞ TÖRÜNER, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
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