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

Type 2 Diabetes Clinical Trial

Official title:

Investigation of the Effects of Calisthenic Exercises Performed With Telerehabilitation on Oxygen Consumption, Muscle Oxygenation and Physical Activity in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222086
• Other study ID #: Gazi University65
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: Gazi University
• Contact: Meral BOSNAK GÜÇLÜ, Prof. Dr.
• Phone: +903122162647
• Email: meralbosnak[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Upper extremity functional exercise capacity	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
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	Respiratory Muscle Strength	Maximal inspiratory (MIP) 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
Secondary	Respiratory Muscle Strength	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
Secondary	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.	through study completion, an average of 2 year
Secondary	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).	through study completion, an average of 2 year
Secondary	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."	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	Daytime Sleepiness	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
Secondary	Sleep Quality	The Turkish adaptation of the Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate sleep quality. The scale is an individually evaluated scale that evaluates sleep quality and sleep disturbance in the last month. The scale includes twenty-four questions. 19 questions are individual evaluation questions. Five questions are answered by the spouse or roommate but are not included in the calculation. The questions included in the scoring consist of seven components: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. Each component is scored on a scale of 0-3 points. The total scale score is obtained by the total score of the seven components. Total PSQI score varies between 0-21. A total score greater than five indicates "poor sleep quality".	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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.	through study completion, an average of 2 year
Secondary	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 (%).	through study completion, an average of 2 year