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Type2diabetesNCT06132334

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

A study testing Upper extremity aerobic exercise training in people with Type2diabetes, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type2diabetes
What is being tested?
Upper extremity aerobic exercise training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 May 2024to 15 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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,
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic

    Çankaya, Ankara, 06560

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions
Type2diabetes
Being tested
Upper extremity aerobic exercise training, Control Group
Keywords
Type 2 Diabetes Mellitus, Muscle oxygen, Oxygen consumption, Physical activity
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upper extremity aerobic exercise trainingOther

    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 GroupOther

    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.

Study groups in NCT06132334
Study groupRoleWhat they receive
Upper extremity aerobic exercise trainingExperimentalThe training group will receive upper extremity aerobic exercise training on an arm ergometer accompanied by a physiotherapist for 6 weeks.
Receives: Other: Upper extremity aerobic exercise training
Control GroupSham comparatorThe control group will not be given any training for 6 weeks during the study period.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygen consumption

    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.

    Measured: through study completion, an average of 2 year

  2. Muscle oxygenation

    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.

    Measured: through study completion, an average of 2 year

  3. Physical activity level

    A multi-sensor activity monitor will be used to assess the level of physical activity

    Measured: through study completion, an average of 2 year

Secondary outcomes (19)

  1. Upper extremity functional exercise capacity

    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.

    Measured: through study completion, an average of 2 year

  2. Pulmonary function (Forced vital capacity (FVC))

    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.

    Measured: through study completion, an average of 2 year

  3. Pulmonary function (Forced expiratory volume in the first second (FEV1))

    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.

    Measured: through study completion, an average of 2 year

  4. Pulmonary function (FEV1 / FVC)

    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.

    Measured: through study completion, an average of 2 year

  5. Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

    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.

    Measured: through study completion, an average of 2 year

  6. Pulmonary function (Peak flow rate (PEF))

    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.

    Measured: through study completion, an average of 2 year

  7. Dual task performance

    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.

    Measured: through study completion, an average of 2 year

  8. Respiratory Muscle Strength

    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

    Measured: through study completion, an average of 2 year

  9. Respiratory Muscle Endurance

    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.

    Measured: through study completion, an average of 2 year

  10. Peripheral muscle strength (N)

    Shoulder flexion muscles and Quadriceps femoris muscle strength will be measured by using a hand-held dynamometer. This values is expressed in Newtons (N).

    Measured: through study completion, an average of 2 year

  11. Dyspnea in daily life

    "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."

    Measured: through study completion, an average of 2 year

  12. Fatigue

    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.

    Measured: through study completion, an average of 2 year

  13. Anxiety and Depression

    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.

    Measured: through study completion, an average of 2 year

  14. Sleep Quality

    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.

    Measured: through study completion, an average of 2 year

  15. Life quality

    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.

    Measured: through study completion, an average of 2 year

  16. Diabetes symptoms

    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.

    Measured: through study completion, an average of 2 year

  17. Dyspnea perception

    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.

    Measured: through study completion, an average of 2 year

  18. Peripheral muscle strength (%)

    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.

    Measured: through study completion, an average of 2 year

  19. Upper extremity functional exercise capacity (percentage of the expected value (%))

    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 (%).

    Measured: through study completion, an average of 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2023
  2. Study start20 May 2024
  3. Primary completion1 May 2025
  4. Study completion15 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06132334
Sponsor's protocol ID
Gazi University63
Status last verified
Dec 2025
First submitted
22 Oct 2023
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pan B, Ge L, Xun YQ, Chen YJ, Gao CY, Han X, Zuo LQ, Shan HQ, Yang KH, Ding GW, Tian JH. Exercise training modalities in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis. Int J Behav Nutr Phys Act. 2018 Jul 25;15(1):72. doi: 10.1186/s12966-018-0703-3.

    PubMed 30045740

  • Kanaley JA, Colberg SR, Corcoran MH, Malin SK, Rodriguez NR, Crespo CJ, Kirwan JP, Zierath JR. Exercise/Physical Activity in Individuals with Type 2 Diabetes: A Consensus Statement from the American College of Sports Medicine. Med Sci Sports Exerc. 2022 Feb 1;54(2):353-368. doi: 10.1249/MSS.0000000000002800.

    PubMed 35029593

  • Amadid H, Johansen NB, Bjerregaard AL, Brage S, Faerch K, Lauritzen T, Witte DR, Sandbaek A, Jorgensen ME, Vistisen D. The role of physical activity in the development of first cardiovascular disease event: a tree-structured survival analysis of the Danish ADDITION-PRO cohort. Cardiovasc Diabetol. 2018 Sep 12;17(1):126. doi: 10.1186/s12933-018-0769-x.

    PubMed 30208900

  • Ibanez J, Izquierdo M, Arguelles I, Forga L, Larrion JL, Garcia-Unciti M, Idoate F, Gorostiaga EM. Twice-weekly progressive resistance training decreases abdominal fat and improves insulin sensitivity in older men with type 2 diabetes. Diabetes Care. 2005 Mar;28(3):662-7. doi: 10.2337/diacare.28.3.662.

    PubMed 15735205

  • Balducci S, Zanuso S, Nicolucci A, Fernando F, Cavallo S, Cardelli P, Fallucca S, Alessi E, Letizia C, Jimenez A, Fallucca F, Pugliese G. Anti-inflammatory effect of exercise training in subjects with type 2 diabetes and the metabolic syndrome is dependent on exercise modalities and independent of weight loss. Nutr Metab Cardiovasc Dis. 2010 Oct;20(8):608-17. doi: 10.1016/j.numecd.2009.04.015. Epub 2009 Aug 19.

    PubMed 19695853

  • Ur Rehman SS, Karimi H, Gillani SA, Ahmad S. Effects of supervised structured aerobic exercise training programme on level of Exertion, dyspnoea, VO2 max and Body Mass Index in patients with type 2 diabetes mellitus. J Pak Med Assoc. 2017 Nov;67(11):1670-1673.

    PubMed 29171557

  • Kirwan JP, Solomon TP, Wojta DM, Staten MA, Holloszy JO. Effects of 7 days of exercise training on insulin sensitivity and responsiveness in type 2 diabetes mellitus. Am J Physiol Endocrinol Metab. 2009 Jul;297(1):E151-6. doi: 10.1152/ajpendo.00210.2009. Epub 2009 Apr 21.

    PubMed 19383872

Questions about this trial

What is this clinical trial studying?

A study testing Upper extremity aerobic exercise training in people with Type2diabetes, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen consumption (time frame: through study completion, an average of 2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06132334, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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