Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 9:11 AM
Study NCT ID:
NCT05411458
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Telerehabilitative Aerobic and Relaxation Exercises Patients With Type 2 Diabetes With and Without COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'An experimental study with a randomized controlled crossover design'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Change from Baseline in HbA1c at 12 weeks', 'description': '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'}, {'measure': 'Fasting blood sugar', 'timeFrame': 'Change from Baseline in fasting blood sugar at 12 weeks', 'description': '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).'}, {'measure': 'Exercise capacity', 'timeFrame': 'Change from Baseline in 6 DMW at 12 weeks', 'description': '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.'}, {'measure': 'anxiety', 'timeFrame': 'Change from Baseline in STAI-S and T at 6 and 12 weeks', 'description': '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.'}, {'measure': 'Lower limb Strength', 'timeFrame': 'Change from Baseline in FTSST at 6 and 12 weeks', 'description': "The Five Time Sit to Stand Test (FTSST) is used to measure a patient's functional mobility and muscle strength of their lower extremities."}, {'measure': 'Physical Activity', 'timeFrame': 'Change from Baseline in IPAQ at 12 weeks', 'description': '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'}, {'measure': 'Stress', 'timeFrame': 'Change from Baseline in PSS at 12 weeks', 'description': "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."}, {'measure': 'Heart rates', 'timeFrame': 'Change from Baseline in heart rates at 12 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'Change from Baseline in PSQI at 12 weeks', 'description': '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.'}, {'measure': 'Health Related Quality of Life', 'timeFrame': 'Change from Baseline in SF-12 at 12 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Type 2 Diabetes Mellitus', 'relaxation exercises', 'aerobic exercise', 'Hb A1c', 'Anxiety', 'Stress'], 'conditions': ['COVID-19', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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).\n\nDiabetes 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).\n\nAll 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.\n\n12-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).\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.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\n\nStudy group cases (for cases who have had Covid-19 Disease) in addition to the above-mentioned criteria;\n\n1. Having had COVID-19 at least 1 time in the last 3 months\n2. Having had COVID-19 at least 1 time in the last 3 months and survived the symptoms of the disease without mechanical ventilator support -\n\nExclusion Criteria:\n\n1. Having additional complications such as diabetic neuropathy, nephropathy, and retinopathy\n2. Having a health problem (orthopedic, neurological, internal and cardiorespiratory) that prevents standing up / walking\n3. no internet connection\n4. malignancy, acute inflammation, intestinal tumor\n5. Having cognitive impairment, vision and hearing loss that may interfere with working -'}, 'identificationModule': {'nctId': 'NCT05411458', 'briefTitle': 'Effects of Telerehabilitative Aerobic and Relaxation Exercises Patients With Type 2 Diabetes With and Without COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Bozyaka Training and Research Hospital'}, 'officialTitle': 'Effects of Telerehabilitation Programs Including Aerobic Exercise and Relaxation Training in Patients With Type-2 Diabetes With and Without COVID-19', 'orgStudyIdInfo': {'id': 'IzmirBozyaka-HayriyeYILMAZ-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '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.\n\n12-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.\n\nAn 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.', 'interventionNames': ['Other: Aerobic and Relaxation Exercises']}, {'type': 'OTHER', 'label': 'Control Group', 'description': '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.\n\n12-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.\n\nAn 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.', 'interventionNames': ['Other: Aerobic and Relaxation Exercises']}], 'interventions': [{'name': 'Aerobic and Relaxation Exercises', 'type': 'OTHER', 'description': '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.\n\nAerobic 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.\n\nAn 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.', 'armGroupLabels': ['Control Group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35110', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Hayriye Yılmaz', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Mehmet G KARAKAYA, Prof, PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Muğla Sıtkı Koçman University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bozyaka Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}