Clinical Trials Directory

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CompletedNCT06895161

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Gazi University · Academic / Other
Sex
All
Age
18 Years – 79 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERRemotely supervised exercise at home or outdoorsAerobic exercise at home/outdoors 30 minutes each session,five days a week for three weeks using a Polar H9 heart rate monitor.
OTHERHospital-based exercise programThe aerobic exercise ,30 minutes each session,five days a week for three weeks at cardiopulmonary rehabilitation unit under supervision.
OTHERPhone calls with reinforcement feedbackCalls twice a week that include symptom inquiries and encouraging feedback on exercise

Timeline

Start date
2025-04-01
Primary completion
2025-12-15
Completion
2025-12-15
First posted
2025-03-26
Last updated
2026-04-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06895161. Inclusion in this directory is not an endorsement.