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

NCT05145465 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-06

No results posted yet for this study

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).

Conditions

  • Diabetes Mellitus, Type 2
  • Telerehabilitation

Interventions

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.

Sponsors & Collaborators

  • University of Thessaly

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2021-12-31
Completion
2022-02-28

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145465 on ClinicalTrials.gov