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

December 29, 2025 updated by: Meral Boşnak Güçlü, Gazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Çankaya, Ankara, Turkey (Türkiye), 06560
        • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control Group
The control group will not be given any training for 6 weeks during the study period.
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.
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 year
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.
through study completion, an average of 2 year
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
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: through study completion, an average of 2 year
Fatigue will be assessed with Fatigue Severity Scale (Turkish version). This scale includes 9 items and each item scores from 1 (strong disagreement) to 7 (strong agreement) point. Fatigue Severity Scale total score is calculates by deriving an arithmetic mean. Cut-score of over 4 means significant fatigue and higher score indicates more severe fatigue.
through study completion, an average of 2 year
Upper extremity functional exercise capacity
Time Frame: through study completion, an average of 2 year
It will be evaluated with a 6-minute pegboard and ring test. At the end of six minutes, the total number of rings inserted will be recorded in numbers.
through study completion, an average of 2 year
Pulmonary function (Forced vital capacity (FVC))
Time Frame: through study completion, an average of 2 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. With the device, forced vital capacity (FVC) will be evaluated.
through study completion, an average of 2 year
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time Frame: through study completion, an average of 2 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
through study completion, an average of 2 year
Pulmonary function (FEV1 / FVC)
Time Frame: through study completion, an average of 2 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, FEV1 / FVC will be evaluated.
through study completion, an average of 2 year
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time Frame: through study completion, an average of 2 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
through study completion, an average of 2 year
Pulmonary function (Peak flow rate (PEF))
Time Frame: through study completion, an average of 2 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, peak flow rate (PEF) will be evaluated.
through study completion, an average of 2 year
Dual task performance
Time Frame: through study completion, an average of 2 year
The test consists of 3 parts. Cognitive task, motor task and dual task will be evaluated. Patients will perform the Timed up and go (TUG) task as a single motor task. For the dual task, participants will be asked to perform the TUG test while counting down in increments of 3, starting from 100.As a single cognitive task, the individual will be asked to count down the specified number in increments of 3, while sitting comfortably in a quiet room, for the duration of the single task TUG. The total number of answers and the number of correct answers will be used to calculate the correct response rate as an indicator of cognitive performance during the dual task.
through study completion, an average of 2 year
Respiratory Muscle Strength
Time Frame: through study completion, an average of 2 year
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to American Thoracic Society and European Respiratory Society criteria
through study completion, an average of 2 year
Respiratory Muscle Endurance
Time Frame: through study completion, an average of 2 year
Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load.
through study completion, an average of 2 year
Peripheral muscle strength (N)
Time Frame: through study completion, an average of 2 year
Shoulder flexion muscles and Quadriceps femoris muscle strength will be measured by using a hand-held dynamometer. This values is expressed in Newtons (N).
through study completion, an average of 2 year
Dyspnea in daily life
Time Frame: through study completion, an average of 2 year
"Modified Medical Research Council" dyspnea scale will be used to question dyspnea perception during activities. This scale is a 5-point scale based on rating various physical activities that increase shortness of breath. The lowest and highest values on this scale are as follows: Level 0 "No shortness of breath except strenuous exercise" and level 4 "Too breathless to leave the house or breathless while dressing or undressing."
through study completion, an average of 2 year
Anxiety and Depression
Time Frame: through study completion, an average of 2 year
The Turkish version of the Hospital Anxiety and Depression Scale (HADS) will be used. HADS score ranges from 0-42. A high score indicates increased levels of anxiety and depression.
through study completion, an average of 2 year
Sleep Quality
Time Frame: through study completion, an average of 2 year
It will be evaluated with the Turkish version of the Epworth Sleepiness Scale (EDS). The scale is designed to evaluate the sleepiness level of individuals during the day and is widely used. Total score is between 0-24. The range specified for normal sleep tendency is considered to be 0-10 points. Sleep is disrupted with a score of 11 points or above.
through study completion, an average of 2 year
Life quality
Time Frame: through study completion, an average of 2 year
Quality of life will be evaluated with the Turkish adaptation of the Diabetes Quality of Life Scale (DQOL). The scale is calculated out of 0-100 points. High scores indicate good quality of life.
through study completion, an average of 2 year
Diabetes symptoms
Time Frame: through study completion, an average of 2 year
It will be evaluated with the Diabetes Symptoms Checklist Scale ((DSC-R).The total score and all subscale scores on the scale range from 0 to 5, with higher scores indicating greater symptom burden.
through study completion, an average of 2 year
Dyspnea perception
Time Frame: through study completion, an average of 2 year
Modified Borg Scale: The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath.
through study completion, an average of 2 year
Peripheral muscle strength (%)
Time Frame: through study completion, an average of 2 year
Shoulder flexion muscles and Quadriceps femoris muscle strength will be measured by using a hand-held dynamometer. This values is expressed as a percentage (%) of the expected value.
through study completion, an average of 2 year
Upper extremity functional exercise capacity (percentage of the expected value (%))
Time Frame: through study completion, an average of 2 year
It will be evaluated with a 6-minute pegboard and ring test.The total number of rings each participant is expected to wear will be calculated. The percentage of the number of rings made relative to the expected value will be expressed as a percentage of the expected value (%).
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Director: Meral BOŞNAK GÜÇLÜ, Prof. Dr., Gazi University
  • Study Chair: Fidan YILMAZ, MSc, Gazi University
  • Principal Investigator: Ayşenur SARISAKALOĞLU, MSc, Gazi University
  • Principal Investigator: Serpil GÜLKAN, MD, Pursaklar State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gazi University63

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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