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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05145465
• Other study ID #: 716/23-09-2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 2022

Study information

• Verified date: December 2021
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Telerehabilitation

Intervention

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.

Locations

Country	Name	City	State
Greece	University of Thessaly	Lamia

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	The 6-min walk (6MW) test is commonly used to assess exercise capacity in patients and to track functional change resulting from disease progression or therapeutic intervention.	6 weeks
Primary	Physical activity	International Physical Activity Questionnaire - Short Form This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.	6 weeks
Primary	Hand grip strength	Jamar Hydraulic Hand Dynamometer The Jamar Hydraulic Hand Dynamometer can be used to measure isometric force and peak strength with five adjustable grip positions. The handle easily adjusts from 1 3/8" - 3 3/8" in half-inch increments. This helps track strength and rehabilitation over time.	6 weeks
Primary	Leg strength and endurance	30 second chair stand test Equipment: A chair with a straight back without arm rests (seat 17" high), and a stopwatch and count the number of times the patient comes to a full standing position in 30 seconds.	6 weeks
Primary	Quality of life (QOL)	36-Item Short Form Survey (SF-36) The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.	6 weeks
Primary	HbA1c	HbA1c test, also known as the haemoglobin A1c or glycated haemoglobin test, is an important blood test that gives a good indication of how well your diabetes is being controlled	6 weeks
Primary	Body weight (kg)	Body weight will be calculated by a weighing scale and the unit of measurement will be in kilograms (kg)	6 weeks
Primary	Body height (cm)	Body height will be calculated by a stadiometer and the unit of measurement will be in centimeters (cm)	6 weeks
Primary	Hip size (cm)	hip measurements will be calculated by tape measure and the unit of measurement will be in centimeters ( cm)	6 weeks
Primary	Waist size (cm)	Waist measurements will be calculated by tape measure and the unit of measurement will be in centimeters ( cm)	6 weeks