Clinical trial NCT06895161: Home-Based Tele-Exercise vs. Hospital-Based Exercise Programs in Patients With Prediabetes
Official title: Effectiveness of Home-Based Tele-Exercise vs Center-Based Exercise Programs in Patients With Prediabetes: A Comparative Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prediabetes
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Telemedecine
Keywords: Prediabetes
Telemedicine
Telerehabilitation
Aerobic exercise
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The inclusion of patients with prediabetes who have undergone an oral glucose tolerance test and have impaired fasting glucose or impaired glucose tolerance.Patients will be randomized in to 3 groups; tele-exercise,hospital based exercise or control.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to compare the effects of tele-exercise(TELE) and hospital-based exercise(HBE) on functional capacity (maximum oxygen consumption), glycemic control, quality of life and sleep quality in individuals with prediabetes. Aerobic exercise will be performed 5 days a week for 30 minutes with moderate intensity continuous walking for a total of 3 weeks.While the HBE group will the exercise program under supervision in hospital,the TELE group wil perform the exercise program at home/outdoors using Polar H9 heart rate monitor. The control group (CON) will perform the exercise program at home/outdoors without any monitoring or follow up.

Detailed description: This prospective,randomized,controlled study aims to investigate the comparative effects of tele-exercise and hospital-based exercises on functional capacity,glycemic control,quality of life and sleep quality in individuals with prediabetes. The study is planning to be conducted between April 1, 2025 and December 15, 2025.Among those undergoing oral glucose tolerance testing, patients who meet the appropriate inclusion criteria will be included in the study.Participants will be randomized into 3 groups.Aerobic exercise in all groups will be performed 5 days a week, 30 minutes each day, for a total of 3 weeks.All groups will be initially referred to a dietitian for prediabetes.

In the HBE group patients will undergo supervised exercise sessions in the cardiac rehabilitation (CR) unit, with treadmill. Aerobic exercise will be based on the patient's peak VO2 from a baseline cardiopulmonary exercise test (CPET),aimin to achieve %55-75 of the maximum heart rate.

The TELE group will receive a home based exercise program.Aerobic exercise,such as walking,will be performed for 30 minutes,5 times a week,monitored via Polar H9 heart rate device. Patients will be asked to walk at a heart rate corresponding to 55-75% of the peak VO2 determined by CPET at baseline.Weekly remote follow ups will conduct via phonel calls to asses adherence,review heart rate data and provide encouragament.

The CON group will receive a home based exercise program too.Patients will be asked to walk at a heart rate corresponding to 55-75% of the peak VO2 determined by CPET at baseline.They will be asked to take notes after exercises. But there won't be any monitoring or follow up's to this group.

Initial and final evaluations will include CPET,2-hour glucose,Glucose area under the curve,fasting glucose,fasting insuline,Hba1c,36 Item Short-form (SF-36) Survey,Pittsburgh Sleep Quality Index,body mass index.Also at the end physical activity enjoyment scale will be performed.

Eligibility criteria: Inclusion Criteria:

* Accepting to participate in the study
* ≥18 and \<80 years of age
* With oral glucose tolerance test (after 75 g oral glucose) 2nd hour glucose value: 140-199 mg/dl or fasting blood glucose : 100-125 mg/dl and diagnosed as prediabetes by an endocrinologist

Exclusion Criteria:

* High physical activity: Performing ≥150 minutes of moderate-intensity exercise per week
* Using insulin or oral antidiabetics
* Presence of cardiac and physical conditions that would prevent aerobic exercise
* Presence of neurological disease with significant sensorimotor deficit
* Presence of active malignancy
* Neuropsychiatric disease or condition that may prevent cooperation

Primary outcomes:
measure: 2-hour postprandial glucose
timeFrame: From enrollment day to the end of the exercise program at 3 weeks.
measure: Maximum oxygen consumption (VO2max)
timeFrame: From enrollment day to the end of the exercise program at 3 weeks
measure: Glucose area under the curve (AUC)
timeFrame: From enrollment day to the end of the exercise program at 3 weeks
Secondary outcomes:
measure: Fasting glucose
timeFrame: From enrollment day to the end of the exercise program at 3 weeks.
measure: Fasting insuline
timeFrame: From enrollment day to the end of the exercise program at 3 weeks.
measure: 36-Item Short Form Survey
timeFrame: From enrollment day to the end of the exercise program at 3 weeks
measure: Pittsburgh sleep quality index
timeFrame: From enrollment day to the end of the exercise program at 3 weeks
measure: Hemoglobin A1c (HbA1c)
timeFrame: From enrollment day to the end of the exercise program at 3 weeks
measure: First Minute Heart Rate Recovery
timeFrame: From enrollment day to the end of the exercise program at 3 weeks
measure: VO2 anaerobic threshold (VO2AT)
timeFrame: From enrollment day to the end of the exercise program at 3 weeks
measure: Physical Activity Enjoyment Scale
timeFrame: At the end of the exercise program at 3 weeks
measure: Body Mass Index
timeFrame: From enrollment day to the end of the exercise program at 3 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital,Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Gazi University Faculty of Medicine
name: Çise C Güngör, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Faculty of Medicine
name: Nesrin Ü Demirsoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Faculty of Medicine
name: Levent Karataş, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Faculty of Medicine
name: Muhittin M Yalçın, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Faculty of Medicine
name: Levent A Güngör, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sakaguchi K, Takeda K, Maeda M, Ogawa W, Sato T, Okada S, Ohnishi Y, Nakajima H, Kashiwagi A. Glucose area under the curve during oral glucose tolerance test as an index of glucose intolerance. Diabetol Int. 2015 May 14;7(1):53-58. doi: 10.1007/s13340-015-0212-4. eCollection 2016 Mar.
citation: Duruturk N. Telerehabilitation intervention for type 2 diabetes. World J Diabetes. 2020 Jun 15;11(6):218-226. doi: 10.4239/wjd.v11.i6.218.
citation: Duruturk N, Ozkoslu MA. Effect of tele-rehabilitation on glucose control, exercise capacity, physical fitness, muscle strength and psychosocial status in patients with type 2 diabetes: A double blind randomized controlled trial. Prim Care Diabetes. 2019 Dec;13(6):542-548. doi: 10.1016/j.pcd.2019.03.007. Epub 2019 Apr 20.
citation: Blioumpa C, Karanasiou E, Antoniou V, Batalik L, Kalatzis K, Lanaras L, Pepera G. Efficacy of supervised home-based, real time, videoconferencing telerehabilitation in patients with type 2 diabetes: a single-blind randomized controlled trial. Eur J Phys Rehabil Med. 2023 Oct;59(5):628-639. doi: 10.23736/S1973-9087.23.07855-3. Epub 2023 Jun 23.