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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prediabetes Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) Telemedecine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hospital-based exercise program

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Remotely supervised exercise at home or outdoors

Intervention Type OTHER

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

Phone calls with reinforcement feedback

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Phone calls with reinforcement feedback

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No