Home-Based Tele-Exercise vs. Hospital-Based Exercise Programs in Patients With Prediabetes

Effectiveness of Home-Based Tele-Exercise vs Center-Based Exercise Programs in Patients With Prediabetes: A Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Prediabetes; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Telemedecine
• Intervention / Treatment: Other: Hospital-based exercise program; Other: Remotely supervised exercise at home or outdoors; Other: Phone calls with reinforcement feedback

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06560
      • Gazi University Hospital,Department of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hospital-based exercise group; Participants in the hospital-based exercise group will perform aerobic exercises under the supervision of a nurse/research doctor five days a week for three weeks in the cardiopulmonary rehabilitation unit.Aerobic exercise will include 30-minute treadmill walking at %55-75 of the maximal heart rate.At the end of three weeks the program will be terminated and a follow-up evaluation will be conducted.	Other: Hospital-based exercise program; The aerobic exercise ,30 minutes each session,five days a week for three weeks at cardiopulmonary rehabilitation unit under supervision.
Experimental: Tele-exercise group; Participants in the tele-exercise group will be instructed to walk continuously at moderate intensity (between 55-75% of the maximum heart rate) at home or outdoors five days a week, 30 minutes each, for three weeks usuing the heart rate monitor( Polar H9).The heart rates will be monitored by providing remote access to the data of the polar. Participants will be trained in the CPET performed before treatment to walk in a way that will keep their heart rates within the desired range.During the program the researcher will call them twice a week.Phone calls will include symptom inquiry and encouraging feedback regarding exercise parameters recorded on the Polar H9. At the end of three weeks the program will be terminated and a follow-up evaluation will be conducted.	Other: Remotely supervised exercise at home or outdoors; Aerobic exercise at home/outdoors 30 minutes each session,five days a week for three weeks using a Polar H9 heart rate monitor.; Other: Phone calls with reinforcement feedback; Calls twice a week that include symptom inquiries and encouraging feedback on exercise
No Intervention: Control group; Patients will be advised to exercise at a moderate intensity (between 55-75% of maximum heart rate) five days a week, 30 minutes each, for 3 weeks, at home or outdoors as recommended for prediabetes in the routine.Participants in this group will not be monitored with Polar or any device.They will be asked to take note of the exercise they have done. Participants will be trained in the CPET performed before treatment to walk in a way to maintain their heart rate in the desired range. At the end of three weeks the program will be terminated and a follow-up evaluation will be conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-hour postprandial glucose	Plasma glucose level is measured 2 hours after the person drinks 75 g of glucose solution.(oral glucose tolerence test). Below 140 mg/dL normal, 140-199 mg/dL prediabetes, 200 mg/dL or higher indicates diabetes.	From enrollment day to the end of the exercise program at 3 weeks.
Maximum oxygen consumption (VO2max)	It is the highest amount of oxygen that patients can consume during incremental aerobic exercise and is considered the best indicator of exercise capacity.	From enrollment day to the end of the exercise program at 3 weeks
Glucose area under the curve (AUC)	It is the value obtained by calculating the area under the curve after 75 g of Oral Glucose Tolerance Test. PG=Plasma glucose Formule is; ( PG(0) +PG(30)×2+PG(60)×3+PG(120)×2 )/4 Glucose excursion, rather than PG levels at a point, is considered to provide more information about glucose tolerance. The glucose area under the curve (AUC), which is an index of whole glucose excursion after glucose loading, has been widely used for calculating the glycemic index and for evaluating the efficacy of treatment for postprandial hyperglycemia	From enrollment day to the end of the exercise program at 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Fasting glucose (Fasting Blood Sugar, FBS) refers to the blood sugar level measured after at least 8-12 hours of fasting, usually in the morning before eating or drinking anything (except water). It is one of the primary tests used to screen for diabetes, prediabetes, and overall glucose metabolism.If 70-99 mg/dl normal, 100-126 mg/dl prediabetes, 126 mg/dl or higher indicates diabetes.	From enrollment day to the end of the exercise program at 3 weeks.
Fasting insuline	It is tested in blood taken after 8-12 hours of fasting.Evaluates insulin sensitivity and resistance. High fasting insulin levels can indicate insulin resistance, where the body doesn't respond well to insulin.	From enrollment day to the end of the exercise program at 3 weeks.
First Minute Heart Rate Recovery	Heart rate recovery (HRR) refers to the rate at which the heart rate declines following the cessation of exercise,reflecting the balance of autonomic nervous system function,specifically the reactivation of parasympathetic(vagal) tone and withdrawal of sympathetic stimulation.In this study HRR will be assessed as the reduction in heart rate within the first minute of recovery after maximal exertion during exercise testing.A faster HRR is generally considered a mareker of superior cardiovascular fitness and autonomic funciton.Prediabetes is associated with autonomic dysfunction.	From enrollment day to the end of the exercise program at 3 weeks
VO2 anaerobic threshold (VO2AT)	VO2 anaerobic threshold (VO2AT) refers to the specific volume of oxygen consumed per minute (VO2) when the body reaches the anaerobic threshold (AT) during exercise. The anaerobic threshold (also known as the lactate threshold) is the point where there is a significant shift in the body's energy system from primarily aerobic metabolism (using oxygen) to anaerobic metabolism (without enough oxygen).	From enrollment day to the end of the exercise program at 3 weeks
Body Mass Index	Body Mass Index (BMI) is a numerical measurement that helps assess whether a person has a healthy body weight relative to their height. BMI = weight (kg) / height (m²)	From enrollment day to the end of the exercise program at 3 weeks
36-Item Short Form Survey	It is a 36-item, patient-reported survey of patient health.It consists of eight scaled scores(vitality,physical functioning,bodily pain,general health perceptions,physical role functioning,emotional role functioning,social role functioning,mental health or emotional wellbeing) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	From enrollment day to the end of the exercise program at 3 weeks
Pittsburgh sleep quality index	The questionnaire consists of a combination of Likerttype and open-ended questions . Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality.. Each component score of the questionnaire ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties	From enrollment day to the end of the exercise program at 3 weeks
Hemoglobin A1c (HbA1c)	HbA1c is a blood test that measures average blood sugar (glucose) levels over the past 2 to 3 months. It's a key marker used to diagnose and monitor diabetes and is considered one of the most reliable indicators of long-term blood glucose control.If below %5,7 normal, %5,7-6,4 prediabetes, %6,5 or higher indicates diabetes.	From enrollment day to the end of the exercise program at 3 weeks
Physical Activity Enjoyment Scale	It is an 8-item scale consisting of a single dimension that evaluates positive emotions such as expected or perceived pleasure and enjoyment from physical activities. Participants are asked to indicate the extent to which they agree with each item on a seven-point scale ranging from 1 - strongly disagree to 7 - strongly agree.Higher scores indicate greater enjoyment of physical activity	At the end of the exercise program at 3 weeks

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Levent Karataş, MD, Gazi University Faculty of Medicine; Principal Investigator: Çise C Güngör, MD, Gazi University Faculty of Medicine; Principal Investigator: Nesrin Ü Demirsoy, MD, Gazi University Faculty of Medicine; Principal Investigator: Muhittin M Yalçın, MD, Gazi University Faculty of Medicine; Principal Investigator: Levent A Güngör, MD, Gazi University Faculty of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine; Aerobic exercise; Prediabetes; Telerehabilitation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Hyperglycemia; Nutritional and Metabolic Diseases; Insulin Resistance; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: Prediabetes and exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No