Effects of Telerehabilitative Aerobic and Relaxation Exercises Patients With Type 2 Diabetes With and Without COVID-19

NCT05411458 | Completed

• 1 other identifier: IzmirBozyaka-HayriyeYILMAZ-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Type-2 Diabetes Mellitus (DM) disease, like other chronic diseases, is a group of diseases that are adversely affected by the COVID-19 pandemic.This study was planned to examine the effect of COVID-19 disease on patients with Type-2 DM and to investigate the effects of progressive relaxation exercises to be given as tele-rehabilitative on stress, anxiety and blood glucose levels and HbA1c value.

Conditions

COVID-19; Type 2 Diabetes Mellitus

Keywords

COVID-19; Type 2 Diabetes Mellitus; relaxation exercises; aerobic exercise; Hb A1c; Anxiety; Stress

Outcome Measures

Primary Outcomes (8)

• HbA1c

  HbA1c test, also known as the haemoglobin A1c or glycated haemoglobin test, is an important blood test that gives a good indication of how well your diabetes is being controlled

  Change from Baseline in HbA1c at 12 weeks

• Fasting blood sugar

  Expected values as a result of fasting blood glucose measurement range from 70 mg/dL (3.9 mmol/L) to 100 mg/dL (5.6 mmol/L).

  Change from Baseline in fasting blood sugar at 12 weeks

• Exercise capacity

  The 6-min walk (6MW) test is commonly used to assess exercise capacity in patients and to track functional change resulting from disease progression or therapeutic intervention.

  Change from Baseline in 6 DMW at 12 weeks

• anxiety

  Spielberg State-Trait Anxiety Inventory (STAI-S and T) was used to assess anxiety. The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety.

  Change from Baseline in STAI-S and T at 6 and 12 weeks

• Lower limb Strength

  The Five Time Sit to Stand Test (FTSST) is used to measure a patient's functional mobility and muscle strength of their lower extremities.

  Change from Baseline in FTSST at 6 and 12 weeks

• Physical Activity

  The International Physical Activity Questionnaire (IPAQ) is a frequently used instrument for the evaluation of physical activity (PA). It was developed in order to assess physical activity in adults aged 18-65 years

  Change from Baseline in IPAQ at 12 weeks

• Stress

  The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.

  Change from Baseline in PSS at 12 weeks

• Heart rates

  Heart rates(beats/min) were measured before and after treatments. Measurements were made by the method of measuring the individual's own heart rate from the radial artery. Normal resting heart rate for adults ranges from 60 to 100 beats per minute.

  Change from Baseline in heart rates at 12 weeks

Secondary Outcomes (2)

• Sleep quality

  Change from Baseline in PSQI at 12 weeks

• Health Related Quality of Life

  Change from Baseline in SF-12 at 12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group consists of 15 Type-2 DM patients who applied for routine outpatient follow-up in the internal medicine clinic, whose diabetes tests and treatments were arranged by an internist, who had COVID-19 at least 3 months ago. 12-week treatment program; A - 6 weeks of aerobic exercise (AE) (outdoor walking program) 6 week program B - Jacobson Progressive Relaxation Exercises (JIGE) (done by patients at home). The 6-week B program (JIGE) was applied in addition to the aerobic exercise (AE) program. An exercise program is 30-45 minutes, and the applications are done every other day and 3 days a week.The treatment programs started with the evaluation of the cases by the physiotherapist and are followed up using the Telerehabilitation method. At the beginning of each week, the patients were called and checked, and their exercise treatments were completed at the end of 12 weeks.

Other: Aerobic and Relaxation Exercises

Control Group

OTHER

Control group consists of 15 Type-2 DM patients without COVID-19, who applied to the internal medicine outpatient clinic for routine outpatient follow-up, whose diabetes examinations and treatments were arranged by an internist. 12-week treatment program; A - 6 weeks of aerobic exercise (AE) (outdoor walking program) 6 week program B - Jacobson Progressive Relaxation Exercises (JIGE) (done by patients at home). The 6-week B program (JIGE) was applied in addition to the aerobic exercise (AE) program. An exercise program is 30-45 minutes, and the applications are done every other day and 3 days a week.The treatment programs started with the evaluation of the cases by the physiotherapist and are followed up using the Telerehabilitation method. At the beginning of each week, the patients were called and checked, and their exercise treatments were completed at the end of 12 weeks.

Other: Aerobic and Relaxation Exercises

Interventions

Aerobic and Relaxation Exercises OTHER

12-week treatment program; A - 6 weeks of aerobic exercise (AE) (outdoor walking program) 6 week program B - Jacobson Progressive Relaxation Exercises (JIGE) (done by patients at home). The 6-week B program (JIGE) was applied in addition to the aerobic exercise (AE) program. Aerobic exercise (AE) program:The aerobic training program was applied as walking for 40 minutes in the open air. The Rating of Perceived Exertion (RPE) Borg Scale (6-20) was used to determine the walking pace, and they were asked to walk according to the light (11-12) level according to the Borg scale. An exercise program is 30-45 minutes, and the applications are done every other day and 3 days a week.The treatment programs started with the evaluation of the cases by the physiotherapist and are followed up using the Telerehabilitation method. At the beginning of each week, the patients were called and checked, and their exercise treatments were completed at the end of 12 weeks.

Control Group; Experimental 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:

• Volunteer patients diagnosed with Type-2 DM by a specialist 2.18 to 65 years of age 3.To have control of comorbid diseases in the last 3 months 4.Not having any condition that prevents exercise 5.Voluntarily exercising three days a week
• Study group cases (for cases who have had Covid-19 Disease) in addition to the above-mentioned criteria;
• Having had COVID-19 at least 1 time in the last 3 months
• Having had COVID-19 at least 1 time in the last 3 months and survived the symptoms of the disease without mechanical ventilator support -

You may not qualify if:

• Having additional complications such as diabetic neuropathy, nephropathy, and retinopathy
• Having a health problem (orthopedic, neurological, internal and cardiorespiratory) that prevents standing up / walking
• no internet connection
• malignancy, acute inflammation, intestinal tumor
• Having cognitive impairment, vision and hearing loss that may interfere with working -

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Hayriye Yılmaz

Izmir, 35110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Diabetes Mellitus, Type 2; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders

Study Officials

• Mehmet G KARAKAYA, Prof, PT

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: An experimental study with a randomized controlled crossover design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: May 1, 2021
• Primary Completion: August 10, 2022
• Study Completion: November 15, 2022
• Last Updated: February 15, 2023

Record last verified: 2022-05

Locations

TU (1)