Clinical trial NCT05411458: Effects of Telerehabilitative Aerobic and Relaxation Exercises Patients With Type 2 Diabetes With and Without COVID-19
Official title: Effects of Telerehabilitation Programs Including Aerobic Exercise and Relaxation Training in Patients With Type-2 Diabetes With and Without COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Type 2 Diabetes Mellitus
Keywords: COVID-19
Type 2 Diabetes Mellitus
relaxation exercises
aerobic exercise
Hb A1c
Anxiety
Stress
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

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. malignancy, acute inflammation, intestinal tumor
5. Having cognitive impairment, vision and hearing loss that may interfere with working -

Primary outcomes:
measure: HbA1c
timeFrame: Change from Baseline in HbA1c at 12 weeks
measure: Fasting blood sugar
timeFrame: Change from Baseline in fasting blood sugar at 12 weeks
measure: Exercise capacity
timeFrame: Change from Baseline in 6 DMW at 12 weeks
measure: anxiety
timeFrame: Change from Baseline in STAI-S and T at 6 and 12 weeks
measure: Lower limb Strength
timeFrame: Change from Baseline in FTSST at 6 and 12 weeks
measure: Physical Activity
timeFrame: Change from Baseline in IPAQ at 12 weeks
measure: Stress
timeFrame: Change from Baseline in PSS at 12 weeks
measure: Heart rates
timeFrame: Change from Baseline in heart rates at 12 weeks
Secondary outcomes:
measure: Sleep quality
timeFrame: Change from Baseline in PSQI at 12 weeks
measure: Health Related Quality of Life
timeFrame: Change from Baseline in SF-12 at 12 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Hayriye Yılmaz
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Mehmet G KARAKAYA, Prof, PT
role: STUDY_DIRECTOR
References: