Diabetes Mellitus, Type 2NCT05145465
The Effect of a Supervised Home-based Tele-rehabilitation Program on Patients With Type 2 Diabetes
A study testing Telerehabilitation group in people with Diabetes Mellitus, Type 2 and Telerehabilitation, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Telerehabilitation
- What is being tested?
- Telerehabilitation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes type 2
- regulated blood sugar
- treatment by doctor
- greek language
Who cannot join
- no internet connection
- diabetes type 1
- recently surgery
- mental health problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blinded Randomized Controlled Trial , Investigating the Efficacy of Telerehabilitation, Type 2 Diabetes Telerehabilitation,
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.
Read more
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).
Read the 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:
- 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
- Conditions
- Diabetes Mellitus, Type 2, Telerehabilitation
- Being tested
- Telerehabilitation group
- Keywords
- Supervised Exercise, Functional capacity, Hand grip
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | 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) Receives: Other: Telerehabilitation group |
| control group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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
Measured: 6 weeks
Body weight (kg)
Body weight will be calculated by a weighing scale and the unit of measurement will be in kilograms (kg)
Measured: 6 weeks
Body height (cm)
Body height will be calculated by a stadiometer and the unit of measurement will be in centimeters (cm)
Measured: 6 weeks
Hip size (cm)
hip measurements will be calculated by tape measure and the unit of measurement will be in centimeters ( cm)
Measured: 6 weeks
Waist size (cm)
Waist measurements will be calculated by tape measure and the unit of measurement will be in centimeters ( cm)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Sep 2021
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garyfallia Pepera, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145465
- Sponsor's protocol ID
- 716/23-09-2021
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Controlled Trial , Investigating the Efficacy of Telerehabilitation, Type 2 Diabetes Telerehabilitation,
- ClinicalTrials.gov ID
- NCT05145465
- Acronym / sponsor ID
- 716/23-09-2021
- Conditions
- Diabetes Mellitus, Type 2, Telerehabilitation
- Keywords
- Supervised Exercise, Functional capacity, Hand grip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Other: Telerehabilitation groupParticipants 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) |
| control group | No intervention | –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). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diabetes type 2
- regulated blood sugar
- treatment by doctor
- greek language
Key exclusion criteria (4 listed)
- no internet connection
- diabetes type 1
- recently surgery
- mental health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation groupAll 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. | Other | Telerehabilitation group |
Primary outcome
Exercise capacity
Time frame: 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.
Physical activity
Time frame: 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.
Hand grip strength
Time frame: 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
Time frame: 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.
Quality of life (QOL)
Time frame: 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.
HbA1c
Time frame: 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
Body weight (kg)
Time frame: 6 weeks
Body weight will be calculated by a weighing scale and the unit of measurement will be in kilograms (kg)
Body height (cm)
Time frame: 6 weeks
Body height will be calculated by a stadiometer and the unit of measurement will be in centimeters (cm)
Hip size (cm)
Time frame: 6 weeks
hip measurements will be calculated by tape measure and the unit of measurement will be in centimeters ( cm)
Waist size (cm)
Time frame: 6 weeks
Waist measurements will be calculated by tape measure and the unit of measurement will be in centimeters ( cm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation group in people with Diabetes Mellitus, Type 2 and Telerehabilitation, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 6 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.