The Effect of a Supervised Home-based Tele-rehabilitation Program on Patients With Type 2 Diabetes
NCT ID: NCT05145465
Last Updated: 2021-12-06
Study Results
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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UNKNOWN
NA
24 participants
INTERVENTIONAL
2021-09-01
2022-02-28
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Telerehabilitation group
Participants will undertake the first training session in the University of Thessaly under the supervision of a specialized physiotherapist in order to precept the exercises. All the other sessions will proceed via telerehabilitation program at their home. Participants will undergo an exercise home based program 3 times/week.
The program will start with 10 minutes warm up exercise , 20 minutes continuous aerobic exercise ( 60-80% of target heart rate), 20 minutes resistance training exercise ( 30-50% 1RM), 5 minutes cool down and breathing exercises. For their safety patients will monitor glucose, blood pressure, pulse-oxygen and heart rate via, blood pressure monitor, pulse oximeter and smart-watch devices. They will be assessed at the beginning of the study and after the intervention ( at 6 weeks)
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.
control group
The participants in this group will just receive the education session and they will continue their current medical therapies.They will be assessed at the beginning of the study and after the intervention ( at 6 weeks).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* regulated blood sugar
* treatment by doctor
* greek language
Exclusion Criteria
* diabetes type 1
* recently surgery
* mental health problems
40 Years
75 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Garyfallia Pepera
Assistant Professor in Cardiovascular Physiotherapy/Cardiac Rehabilitation
Locations
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University of Thessaly
Lamia, , Greece
Countries
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Other Identifiers
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716/23-09-2021
Identifier Type: -
Identifier Source: org_study_id