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

NCT06895161 | Completed

• 1 other identifier: Prediabetes and exercise
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prediabetes; Telemedicine; Telerehabilitation; Aerobic exercise

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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

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

Secondary Outcomes (9)

• Fasting glucose

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

• Fasting insuline

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

• 36-Item Short Form Survey

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

• Pittsburgh sleep quality index

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

• Hemoglobin A1c (HbA1c)

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

Study Arms (3)

Hospital-based exercise group

ACTIVE COMPARATOR

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.

Other: Hospital-based exercise program

Tele-exercise group

EXPERIMENTAL

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.

Other: Remotely supervised exercise at home or outdoors; Other: Phone calls with reinforcement feedback

Control group

NO INTERVENTION

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.

Interventions

Remotely supervised exercise at home or outdoors OTHER

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

Tele-exercise group

Hospital-based exercise program OTHER

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

Hospital-based exercise group

Phone calls with reinforcement feedback OTHER

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

Tele-exercise group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital,Department of Physical Medicine and Rehabilitation

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 30603243 RESULT

• 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.

  PMID: 32547696 RESULT

• 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.

  PMID: 31014938 RESULT

• 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.

  PMID: 37350165 RESULT

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Study Officials

• Çise C Güngör, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Nesrin Ü Demirsoy, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Levent Karataş, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Muhittin M Yalçın, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Levent A Güngör, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PM&R Specialist M.D

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)