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

Gazi University

Status: Active, not recruiting

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

Treatments: Other: Hospital-based exercise program; Other: Phone calls with reinforcement feedback; Other: Remotely supervised exercise at home or outdoors

Study type: Interventional

Funder types: Other

Identifiers

NCT06895161

Prediabetes and exercise

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 3 patient groups

Hospital-based exercise group

Active Comparator group

Description:

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.

Treatment:

Other: Hospital-based exercise program

Tele-exercise group

Experimental group

Description:

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.

Treatment:

Other: Phone calls with reinforcement feedback

Other: Remotely supervised exercise at home or outdoors

Control group

No Intervention group

Description:

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.