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Clinical Trials/NCT06132334
NCT06132334
Completed
Not Applicable

The Effects of Upper Extremity Aerobic Exercise Training on Exercise Capacity, Muscle Oxygen, and Physical Activity Level in Patients With Type 2 Diabetes

Gazi University1 site in 1 country40 target enrollmentMay 20, 2024
ConditionsType2diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type2diabetes
Sponsor
Gazi University
Enrollment
40
Locations
1
Primary Endpoint
Muscle oxygenation
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2024
End Date
May 15, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation

Gazi University

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.

Outcomes

Primary Outcomes

Muscle oxygenation

Time Frame: through study completion, an average of 2 year

Before the cardiopulmonary exercise test and the 6-minute pegboard and ring test (6-PBRT), during and after the tests the muscle oxygenation will be measured by using a near-infrared spectroscopy device.

Physical activity level

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • Peripheral muscle strength (%)(through study completion, an average of 2 year)
  • Upper extremity functional exercise capacity(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)
  • Respiratory Muscle Strength(through study completion, an average of 2 year)
  • Fatigue(through study completion, an average of 2 year)
  • Life quality(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 (Peak flow rate (PEF))(through study completion, an average of 2 year)
  • Peripheral muscle strength (N)(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)
  • Dual task performance(through study completion, an average of 2 year)
  • Respiratory Muscle Endurance(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)
  • Diabetes symptoms(through study completion, an average of 2 year)
  • Dyspnea perception(through study completion, an average of 2 year)
  • Dyspnea in daily life(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)

Study Sites (1)

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