Clinical trial NCT06132334: The Effects of Upper Extremity Aerobic Exercise Training in Patients With Type 2 Diabetes
Official title: The Effects of Upper Extremity Aerobic Exercise Training on Exercise Capacity, Muscle Oxygen, and Physical Activity Level in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2diabetes
Keywords: Type 2 Diabetes Mellitus
Muscle oxygen
Oxygen consumption
Physical activity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-11-15
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 Assignment
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: T2DM 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 functions 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 T2DM patients. To reduce the cardiovascular mortality rate and risk factors associated with cardiovascular disease, physical activity level is important in T2DM patients, as in all populations. Maintaining physical activity level plays a protective role against both T2DM and cardiovascular disease. But traditional exercise training guides generally focus on walking exercises. Because exercises in this form are frequently used in daily life activities. It is known that upper extremity movements are frequently used in daily living activities, and aerobic exercise using the upper extremities is thought to be safe and effective in these patients due to diabetic foot complications. There is no study in the literature investigating the effects of upper extremity aerobic exercise training in T2DM.

The primary aim of the study is to investigate the effects of upper extremity aerobic exercise training applied to T2DM patients on exercise capacity, muscle oxygenation and physical activity level.

The secondary aim of the study is to investigate its effects on upper extremity functional 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: Physical activity level
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 vital capacity (FVC))
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 (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 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: 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: Çankaya
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
state: Ankara
Study officials:
affiliation: Gazi University
name: Fidan YILMAZ, MSc
role: STUDY_CHAIR
affiliation: Gazi University
name: Ayşenur SARISAKALOĞLU, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Pursaklar State Hospital
name: Serpil GÜLKAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
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