Double Blinded Randomized Controlled Trial , Investigating the Efficacy of Telerehabilitation, Type 2 Diabetes Telerehabilitation,
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
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).
详细描述
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:
- Functional capacity assesment tool : six minutes walking test ( 6MWT)
- Physical activity] assesment tool : International Physical Activity Questionnaire (IPAQ).
- Quality of life assesment tool : 36-Item Short Form Survey (SF-36) sf36
- Hand grip strength assesment tool : Jamar Hydraulic Hand Dynamometer
- Leg strength and endurance assesment tool 30 second chair stand test
- Weight, hip , waist and BMI measurements
- HbA1c level assesment tool : blood test
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes type 2
- •regulated blood sugar
- •treatment by doctor
- •greek language
排除标准
- •no internet connection
- •diabetes type 1
- •recently surgery
- •mental health problems
结局指标
主要结局
HbA1c
时间窗: 6 weeks
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
Physical activity
时间窗: 6 weeks
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.
Waist size (cm)
时间窗: 6 weeks
Waist measurements will be calculated by tape measure and the unit of measurement will be in centimeters ( cm)
Exercise capacity
时间窗: 6 weeks
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.
Body height (cm)
时间窗: 6 weeks
Body height will be calculated by a stadiometer and the unit of measurement will be in centimeters (cm)
Hand grip strength
时间窗: 6 weeks
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.
Leg strength and endurance
时间窗: 6 weeks
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.
Body weight (kg)
时间窗: 6 weeks
Body weight will be calculated by a weighing scale and the unit of measurement will be in kilograms (kg)
Quality of life (QOL)
时间窗: 6 weeks
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.
Hip size (cm)
时间窗: 6 weeks
hip measurements will be calculated by tape measure and the unit of measurement will be in centimeters ( cm)
次要结局
未报告次要终点
研究者
Garyfallia Pepera
Assistant Professor in Cardiovascular Physiotherapy/Cardiac Rehabilitation
University of Thessaly