Clinical trial NCT05145465: The Effect of a Supervised Home-based Tele-rehabilitation Program on Patients With Type 2 Diabetes
Official title: Double Blinded Randomized Controlled Trial , Investigating the Efficacy of Telerehabilitation, Type 2 Diabetes Telerehabilitation,
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Telerehabilitation
Keywords: Supervised Exercise
Functional capacity
Hand grip
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Exercise capacity
timeFrame: 6 weeks
measure: Physical activity
timeFrame: 6 weeks
measure: Hand grip strength
timeFrame: 6 weeks
measure: Leg strength and endurance
timeFrame: 6 weeks
measure: Quality of life (QOL)
timeFrame: 6 weeks
measure: HbA1c
timeFrame: 6 weeks
measure: Body weight (kg)
timeFrame: 6 weeks
measure: Body height (cm)
timeFrame: 6 weeks
measure: Hip size (cm)
timeFrame: 6 weeks
measure: Waist size (cm)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: University of Thessaly
Study officials:
References: