The Effects of Calisthenic Exercise Training in Patients With Type 2 Diabetes

NCT06222086 | Completed

• 1 other identifier: Gazi University65
• 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

Type 2 Diabetes

Keywords

Type 2 diabetes; Calisthenic Exercise Training; Oxygen consumption; Muscle oxygen

Outcome Measures

Primary Outcomes (4)

• 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 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

• Muscle oxygenation

  Before 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 assessment with multi-sensor activity tracking

  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 (21)

• Upper extremity functional exercise capacity

  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 (Forced vital capacity (FVC))

  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)

Calisthenic exercise training with telerehabilitation

EXPERIMENTAL

The training group will be given calisthenic exercise training via video conference accompanied by a physiotherapist for 6 weeks.

Other: Calisthenic exercise training with telerehabilitation

Control Group

SHAM COMPARATOR

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

Other: Control Group

Interventions

Calisthenic exercise training with telerehabilitation OTHER

The training group will be given calisthenic exercise training 30-45 minutes a day, 3 days a week, via video conference, accompanied by a physiotherapist, for 6 weeks. The training workload of aerobic exercise training will be applied at 60-80% of peak heart rate, with dyspnea 3-4 points or fatigue 4-6 points according to the Modified Borg Scale (MBS). Blood sugar measurement will be taken before exercise training. People whose blood sugar result is \>300 mg/dL will not be allowed to exercise that day.

Calisthenic exercise training with telerehabilitation

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

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 Unit

Ankara, Çankaya, 06490, 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

Interventions

Telerehabilitation; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayşenur SARISAKALOĞLU, MSc

  Gazi University

  STUDY CHAIR

• Fidan YILMAZ, MSc

  Gazi University

  PRINCIPAL INVESTIGATOR

• Füsun BALOŞ TÖRÜNER, Prof. Dr.

  Gazi University

  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

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 24, 2024
• Study Start: May 20, 2024
• Primary Completion: May 30, 2025
• Study Completion: September 15, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)