ClinicalTrials.gg
CompletedNCT05411458Updated Aug 21, 2026

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

An interventional study of Aerobic and Relaxation Exercises in COVID-19 and Type 2 Diabetes Mellitus, sponsored by Bozyaka Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Bozyaka Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2021, registered Jun 2022).

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 429 studies in COVID-19 with a site in Turkey — 9 open to participants now, 11 under way, 3 of them phase 3. COVID-19 · Turkey.

Enrollment
143rd of 178
30 · median 64
Started
2021
with 165 others
No phase
123 of 429
4 open now
Registered
335th of 429
by date

Among the 429 studies in COVID-19 with a site in Turkey, this one is the 143rd largest by enrollment of the 178 interventional ones that give a count, is one of 166 that started in 2021, is one of 123 with no phase, and was the 335th registered.

COVID-19

7,992 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Open to participants now

9 of the 429 studies in COVID-19 with a site in Turkey are open now. Recruiting first, the newest first:

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All 9 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

30 Type-2 DM patients whose diabetes examinations and treatments were performed by an internist in the internal medicine outpatient clinic of Izmir Bozyaka Training and Research Hospital will be included in the study. (study group: 15 cases who had COVID-19 at least three months ago and control group: 15 cases who did not have COVID-19) Physical characteristics such as age (year), gender, body weight (kg), height (cm), body mass index (kg/m2) and sociodemographic characteristics of the cases were questioned. Evaluated by anthropometric measurements (waist and hip circumference (cm) and waist and body composition measurement (Xiaomi MI scale 2).

Diabetes knowledge levels were determined by the Diabetes Knowledge Test (DKT2), physical activity levels were determined by the International Physical Activity Questionnaire-Short form (IPAQ-short form), and sleep quality was determined by the Pittsburg Sleep Quality Index (PUKI). Blood values such as fasting blood glucose (mg/dl), Glycosylated Hemoglobin (HbA1c) (%) of the cases were measured, and the patient was taught to measure the heart rate (beats/minute) in a radial way. Functional capacity levels were determined by the 6-minute walking test (6MWT), lower extremity muscle strength by the Five-Time Sitting Stand Up Test (FTSST), stress levels by the Perceived Stress Scale (PSS) and anxiety levels by Spielberg's State-Trait Anxiety Inventory (STAI-S and T). ) were evaluated with Quality of life was measured with the Short Form-12 (SF-12) and Diabetes-Specific Quality of Life Scale (DQOL).

All evaluations were made face to face with all cases in both groups at the beginning of the study. Then, the same exercise training was applied to the patients in both groups as rehabilitative, in a crossover design, in a random order determined by the lottery for a total of 12 weeks.

12-week treatment program A - 6 weeks of Aerobic exercise (AE) (outdoor walking program) B - 6 week program - Jacobson Progressive Relaxation Exercises (JIGE) (performed by patients at home) were administered in addition to aerobic exercise (AE) (outdoor walking program).

The exercise program is 30-45 minutes and the applications are done every other day and 3 days a week. Patients recorded their Heart Rate (beats/minute) before and after each administration.

The Five Times Standing Test (FTSST) and STAI-S were performed at 6 weeks following treatment (at treatment changes). At the end of the treatment, that is, at the 12th week; 6 DYT and Five Time Sit to Stand Test (FTSST) and IPAQ-short form, SF-12 and DQOL, PSS, STAI-S and T, PUKI scales were re-evaluated. The efficacy of treatments will be compared within and between groups using appropriate statistical methods.

03

Conditions studied

  • COVID-19
  • Type 2 Diabetes Mellitus

Keywords

  • COVID-19
  • Type 2 Diabetes Mellitus
  • relaxation exercises
  • aerobic exercise
  • Hb A1c
  • Anxiety
  • Stress
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1.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;

  1. Having had COVID-19 at least 1 time in the last 3 months
  2. Having had COVID-19 at least 1 time in the last 3 months and survived the symptoms of the disease without mechanical ventilator support -

Exclusion criteria

Exclusion Criteria:

  1. Having additional complications such as diabetic neuropathy, nephropathy, and retinopathy
  2. Having a health problem (orthopedic, neurological, internal and cardiorespiratory) that prevents standing up / walking
  3. no internet connection
  4. , acute inflammation, intestinal tumor
  5. Having cognitive impairment, vision and hearing loss that may interfere with working -
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Experimental group

    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

  • Other
    Control Group

    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

  • OtherAerobic and Relaxation Exercises

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from Baseline in HbA1c at 12 weeks

  2. 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).

    Time frame: Change from Baseline in fasting blood sugar at 12 weeks

  3. 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.

    Time frame: Change from Baseline in 6 DMW at 12 weeks

  4. 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.

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

  5. 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.

    Time frame: Change from Baseline in FTSST at 6 and 12 weeks

  6. 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

    Time frame: Change from Baseline in IPAQ at 12 weeks

  7. 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.

    Time frame: Change from Baseline in PSS at 12 weeks

  8. 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.

    Time frame: Change from Baseline in heart rates at 12 weeks

Secondary outcomes

  1. Sleep quality

    Petersburg sleep quality index (PSQI), PSQI is a eighteen item scale.The total scores range is 0-21. A higher score indicates a worse sleep quality.

    Time frame: Change from Baseline in PSQI at 12 weeks

  2. Health Related Quality of Life

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.

    Time frame: Change from Baseline in SF-12 at 12 weeks

07

Study locations

1 site
  • Hayriye Yılmaz
    Izmir, 35110, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Jul 2022, 8 months.

Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 8 months is below that.

Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2022
First posted
Jun 9, 2022
StartActual
Nov 15, 2021
Primary completionActual
Jul 15, 2022
CompletionActual
Nov 15, 2022
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05411458
Lead sponsor
Bozyaka Training and Research Hospital
Responsible party
Hayriye Yılmaz (MSc,PT, Bozyaka Training and Research Hospital) — Principal investigator
First posted
Jun 9, 2022
Start date
Nov 15, 2021
Primary completion
Jul 15, 2022
Completion
Nov 15, 2022
Last update
Aug 21, 2026

Study contacts

Mehmet G KARAKAYA, Prof, PT
study director · Muğla Sıtkı Koçman University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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