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

Not Applicable

Active, not recruiting

• Conditions: Prediabetes; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Telemedecine

• Registration Number: NCT06895161
• Lead Sponsor: Gazi University

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-26
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
2-hour postprandial glucose	From enrollment day to the end of the exercise program at 3 weeks.	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.
Maximum oxygen consumption (VO2max)	From enrollment day to the end of the exercise program at 3 weeks	It is the highest amount of oxygen that patients can consume during incremental aerobic exercise and is considered the best indicator of exercise capacity.
Glucose area under the curve (AUC)	From enrollment day to the end of the exercise program at 3 weeks	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

Secondary Outcome Measures

Name	Time	Method
Fasting insuline	From enrollment day to the end of the exercise program at 3 weeks.	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.
Body Mass Index	From enrollment day to the end of the exercise program at 3 weeks	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)
Fasting glucose	From enrollment day to the end of the exercise program at 3 weeks.	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.
36-Item Short Form Survey	From enrollment day to the end of the exercise program at 3 weeks	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.
Pittsburgh sleep quality index	From enrollment day to the end of the exercise program at 3 weeks	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
Hemoglobin A1c (HbA1c)	From enrollment day to the end of the exercise program at 3 weeks	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.
First Minute Heart Rate Recovery	From enrollment day to the end of the exercise program at 3 weeks	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.
VO2 anaerobic threshold (VO2AT)	From enrollment day to the end of the exercise program at 3 weeks	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).
Physical Activity Enjoyment Scale	At the end of the exercise program at 3 weeks	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

Trial Locations

Locations (1)

Gazi University Hospital,Department of Physical Medicine and Rehabilitation; 🇹🇷 Ankara, Turkey