The Effects of Upper Extremity Aerobic Exercise Training in Patients With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2025-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type2diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Upper extremity aerobic exercise training

The training group will receive upper extremity aerobic exercise training on an arm ergometer accompanied by a physiotherapist for 6 weeks.

Group Type EXPERIMENTAL

Upper extremity aerobic exercise training

Intervention Type OTHER

Aerobic exercise training will be given to the training group on an arm ergometer 3 days in a week and 30-45 minutes a day for 6 weeks with the assistance of a physiotherapist. The training workload of aerobic exercise training will be applied at 50-80% of peak oxygen consumption or 60-80% of peak heart rate, dyspnea 3-4 points according to the Modified Borg Scale (MBS) or fatigue 4-6 points.

Blood sugar measurement will be performed before exercise training. Individuals with a blood sugar result of \>300 mg/dL will not be allowed to exercise that day.

Control Group

The control group will not be given any training for 6 weeks during the study period.

Group Type SHAM_COMPARATOR

Control Group

Intervention Type OTHER

The control group will not be given any training during the 6-week period. After the study, the treatment applied to the training group will also be applied to the control group in order to ensure that the patients in the control group are not ethically deprived of rehabilitation.

Interventions

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Upper extremity aerobic exercise training

Aerobic exercise training will be given to the training group on an arm ergometer 3 days in a week and 30-45 minutes a day for 6 weeks with the assistance of a physiotherapist. The training workload of aerobic exercise training will be applied at 50-80% of peak oxygen consumption or 60-80% of peak heart rate, dyspnea 3-4 points according to the Modified Borg Scale (MBS) or fatigue 4-6 points.

Blood sugar measurement will be performed before exercise training. Individuals with a blood sugar result of \>300 mg/dL will not be allowed to exercise that day.

Intervention Type OTHER

Control Group

The control group will not be given any training during the 6-week period. After the study, the treatment applied to the training group will also be applied to the control group in order to ensure that the patients in the control group are not ethically deprived of rehabilitation.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No