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PrediabetesNCT06895161

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

A study testing Remotely supervised exercise at home or outdoors, Hospital-based exercise program and Phone calls with reinforcement feedback in people with Prediabetes and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Remotely supervised exercise at home or outdoors, Hospital-based exercise program and Phone calls with reinforcement feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2025to 15 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University Hospital,Department of Physical Medicine and Rehabilitation

    Ankara, Ankara, 06560

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Remotely supervised exercise at home or outdoors, Hospital-based exercise program, Phone calls with reinforcement feedback
Keywords
Prediabetes, Telemedicine, Telerehabilitation, Aerobic exercise
Medical subject headings
Prediabetic State, Insulin Resistance, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remotely supervised exercise at home or outdoorsOther

    Aerobic exercise at home/outdoors 30 minutes each session,five days a week for three weeks using a Polar H9 heart rate monitor.

  • Hospital-based exercise programOther

    The aerobic exercise ,30 minutes each session,five days a week for three weeks at cardiopulmonary rehabilitation unit under supervision.

  • Phone calls with reinforcement feedbackOther

    Calls twice a week that include symptom inquiries and encouraging feedback on exercise

Study groups in NCT06895161
Study groupRoleWhat they receive
Hospital-based exercise groupActive comparatorParticipants 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.
Receives: Other: Hospital-based exercise program
Tele-exercise groupExperimentalParticipants 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.
Receives: Other: Remotely supervised exercise at home or outdoors; Other: Phone calls with reinforcement feedback
Control groupNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment day to the end of the exercise program at 3 weeks.

  2. 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.

    Measured: From enrollment day to the end of the exercise program at 3 weeks

  3. 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

    Measured: From enrollment day to the end of the exercise program at 3 weeks

Secondary outcomes (9)
  1. 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.

    Measured: From enrollment day to the end of the exercise program at 3 weeks.

  2. 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.

    Measured: From enrollment day to the end of the exercise program at 3 weeks.

  3. 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.

    Measured: From enrollment day to the end of the exercise program at 3 weeks

  4. 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

    Measured: From enrollment day to the end of the exercise program at 3 weeks

  5. 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.

    Measured: From enrollment day to the end of the exercise program at 3 weeks

  6. 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.

    Measured: From enrollment day to the end of the exercise program at 3 weeks

  7. 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).

    Measured: From enrollment day to the end of the exercise program at 3 weeks

  8. 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

    Measured: At the end of the exercise program at 3 weeks

  9. 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)

    Measured: From enrollment day to the end of the exercise program at 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion15 Dec 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06895161
Sponsor's protocol ID
Prediabetes and exercise
Status last verified
Apr 2026
First submitted
24 Mar 2025
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30603243
  • 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.

    PubMed 32547696
  • 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.

    PubMed 31014938
  • 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.

    PubMed 37350165

Questions about this trial

What is this clinical trial studying?

A study testing Remotely supervised exercise at home or outdoors, Hospital-based exercise program and Phone calls with reinforcement feedback in people with Prediabetes and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-hour postprandial glucose (time frame: From enrollment day to the end of the exercise program at 3 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06895161, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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