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

NCT ID: NCT06222086

Last Updated: 2026-01-02

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

2025-09-15

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.

Detailed Description

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Type 2 diabetes 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 function 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 patients with T2DM. To reduce the cardiovascular mortality rate and risk factors associated with cardiovascular disease, physical activity level is important in patients with T2DM, as in all populations. Maintaining physical activity level plays a protective role against both T2DM and cardiovascular disease. It is important to give this patient group exercise habits. Calisthenic exercise training via telerehabilitation is an advantageous method of gaining exercise habits in the home environment, without requiring any equipment. Concerns such as the benefits of modern life, time saving and cost reduction have made it necessary to develop new rehabilitation approaches. It is thought that calisthenic exercise training with telerehabilitation will be beneficial for Type 2 Diabetes patients. The primary aim of the study is to investigate the effects of calisthenic exercise training via telerehabilitation on exercise capacity, muscle oxygenation and physical activity level in patients with Type 2 Diabetes Mellitus. The secondary aim of the study is to investigate the effects of calisthenic exercise training via telerehabilitation on 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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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel
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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Calisthenic exercise training with telerehabilitation

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

Group Type EXPERIMENTAL

Calisthenic exercise training with telerehabilitation

Intervention Type 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.

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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Calisthenic exercise training with telerehabilitation

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.

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

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Meral Boşnak Güçlü

Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşenur SARISAKALOĞLU, MSc

Role: STUDY_CHAIR

Gazi University

Fidan YILMAZ, MSc

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Füsun BALOŞ TÖRÜNER, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Locations

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

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30045740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35029593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30208900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15735205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19695853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29171557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19383872 (View on PubMed)

Other Identifiers

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Gazi University65

Identifier Type: -

Identifier Source: org_study_id

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