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

NCT06132334 | Completed

• 1 other identifier: Gazi University63
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2diabetes

Keywords

Type 2 Diabetes Mellitus; Muscle oxygen; Oxygen consumption; Physical activity

Outcome Measures

Primary Outcomes (3)

• 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.

  through study completion, an average of 2 year

• 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.

  through study completion, an average of 2 year

• Physical activity level

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

  through study completion, an average of 2 year

Secondary Outcomes (19)

• Upper extremity functional exercise capacity

  through study completion, an average of 2 year

• Pulmonary function (Forced vital capacity (FVC))

  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 (FEV1 / FVC)

  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

Study Arms (2)

Upper extremity aerobic exercise training

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

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

Other: Control Group

Interventions

Control Group 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.

Control Group

Upper extremity aerobic exercise training 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.

Upper extremity aerobic exercise training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Çankaya, Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 30045740 BACKGROUND

• 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.

  PMID: 35029593 BACKGROUND

• 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.

  PMID: 30208900 BACKGROUND

• 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.

  PMID: 15735205 BACKGROUND

• 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.

  PMID: 19695853 BACKGROUND

• 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.

  PMID: 29171557 BACKGROUND

• 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.

  PMID: 19383872 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Fidan YILMAZ, MSc

  Gazi University

  STUDY CHAIR

• Ayşenur SARISAKALOĞLU, MSc

  Gazi University

  PRINCIPAL INVESTIGATOR

• Serpil GÜLKAN, MD

  Pursaklar State Hospital

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: November 15, 2023
• Study Start: May 20, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 15, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)