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

University of Thessaly

Status: Unknown

Conditions: Telerehabilitation; Diabetes Mellitus, Type 2

Treatments: Other: Telerehabilitation group

Study type: Interventional

Funder types: Other

Identifiers

NCT05145465

716/23-09-2021

Details and patient eligibility

About

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).

Full 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

Enrollment: 24 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetes type 2
• regulated blood sugar
• treatment by doctor
• greek language

Exclusion criteria

• no internet connection
• diabetes type 1
• recently surgery
• mental health problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Telerehabilitation group

Experimental group

Description:

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)

Treatment:

Other: Telerehabilitation group

control group

No Intervention group

Description:

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).