NCT05145465

The Effect of a Supervised Home-based Tele-rehabilitation Program on Patients With Type 2 Diabetes

Double Blinded Randomized Controlled Trial , Investigating the Efficacy of Telerehabilitation, Type 2 Diabetes Telerehabilitation,

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Thessaly · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Tele-rehabilitation (TR) which carries health services distant through using electronic communication systems is an important treatment option. Although TR studies in musculoskeletal system, neurologic and cardio-pulmonary diseases are effective TR studies in type 2 DM patients are limited. TR interventions in patients with type 2 diabetes has not yet sufficiently defined and more studies with different exercise protocols will be an important step for the clinical value of this intervention but also for it's application in clinical practice. Objective: The aim of this study is to evaluate the effectiveness of a telerehabilitation program on glucose control, functional capacity, muscle strength and quality of life in patients with type 2 diabetes. Study design: It is a supervised-double blind randomized controlled trial, comparing two groups (a control group and a telerehabilitation group). The duration of the intervention will last 6 weeks. Setting: home-based patients environments , only the first session in University of Thessaly for educational reason Participants: A total of 22 patients with type 2 diabetes, regardless sex, aged 40 years and older will randomly assign to a telerehabilitation group (n = 11) and a control group (n = 11). Measurements /Assessments Study data will be collected at baseline and after the intervention period ( 6 weeks) by two blinded physiotherapists, in University of Thessaly).

Detailed description

Procedure: The intervention program will last for 6 weeks and the patients in telerehabilitation-group will receive home based exercise program (by video-call with the supervision of a physiotherapist), 3 times per week and the total duration of each session will last for 60 minutes. The control group will not receive any exercise intervention during that period but only an educational session. Clinical assessments wiil be conducted before and 6 weeks after intervention and will include: 1. Functional capacity assesment tool : six minutes walking test ( 6MWT) 2. Physical activity\] assesment tool : International Physical Activity Questionnaire (IPAQ). 3. Quality of life assesment tool : 36-Item Short Form Survey (SF-36) sf36 4. Hand grip strength assesment tool : Jamar Hydraulic Hand Dynamometer 5. Leg strength and endurance assesment tool 30 second chair stand test 6. Weight, hip , waist and BMI measurements 7. HbA1c level assesment tool : blood test

Conditions

• Diabetes Mellitus, Type 2
• Telerehabilitation

Interventions

Type	Name	Description
OTHER	Telerehabilitation group	All the subjects in the telerehabilitation group will measure their heart rate and SpO2 with a pulse oximeter and blood pressure with digital sphygmomanometer themselves before ,during and after the end of each session for safety after they had been taught by physiotherapist. The patients will also oversee their blood sugar level before and after each session in order to prevent hypoglucemia events. The target heart rate for each patient will set at 60-80% of heart rate reserve plus the heart rate rest and wiil be calculated by the physiotherapist for each patient based on if they receive beta blockers medication or not.

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-12-01
• Completion: 2022-02-01
• First posted: 2021-12-06
• Last updated: 2021-12-06

Locations

1 site across 1 country: Greece