Type2 DiabetesNCT03475069
Which Exercises Should Diabetic Patients do?
A study testing Custom Designed Exercises, Plates Exercises and Calisthenics Exercises in people with Type2 Diabetes and Physical Activity, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Type 2 Diabetes Mellitus (DM) is a widespread worldwide disease. Exercise therapy is an effective method but which exercise types are more effective is an important question. This study was designed to compare the effects of three different exercise programs on physical function and quality of life in Type 2 DM. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type2 Diabetes, Physical Activity
- What is being tested?
- Custom Designed Exercises, Plates Exercises and Calisthenics Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2013to 16 Feb 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who can walk independently.
- Patients who accept doing exercises for 12 weeks, 3 days a week properly Patients whose cognitive status are enough for understanding and realizing different exercise types.
Who cannot join
- Patients with orthopaedic or surgical problems that prevent walking.
- Patients with neuropathy that prevent walking.
- Patients who have foot ulcers.
- Patients with neurological problems.
- Patients with cardiac, pulmonary and systematic problems that cause contraindication for exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Special Exercise Program on Physical Function and Quality of Life Versus Plates and Calisthenics Exercises on Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (DM) is a widespread worldwide disease. Exercise therapy is an effective method but which exercise types are more effective is an important question.
This study was designed to compare the effects of three different exercise programs on physical function and quality of life in Type 2 DM. Forty-two patients with Type 2 DM participated in the study. The patients were randomly assigned to three groups. Client based exercises in accordance with physiotherapy assessment were applied to group 1 (aged 51.42±4.60 years; body mass index 35.28±4.21 kg/m² kg/m²), Clinical Plates exercises were applied to group 2 (aged 53.07 ±5.12 years; body mass index 35.56±4.83 kg/m²) and a standard program including calisthenics exercises were applied to group 3 for 12 weeks, 3 days a week. 6 minutes walk test (6 MWT) and physiological cost index (PCI), timed up and go test (TUG) and SF-36 quality of life questionnaire were performed before and after the 12-week exercise program.
- Conditions
- Type2 Diabetes, Physical Activity
- Being tested
- Custom Designed Exercises, Plates Exercises, Calisthenics Exercises
- Keywords
- Type 2 Diabetes Mellitus, Exercise, Physical Performance, Physiological Cost Index
- Medical subject headings
- Motor Activity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom Designed ExercisesOther
Plates ExercisesOther
Calisthenics ExercisesOther
| Study group | Role | What they receive |
|---|---|---|
| Individual intervention | Experimental | This exercise program was prepared specific to each patient in this group according to his/her physiotherapy assessment, functional performance tests and body analysis results. This exercise type focuses on patients' physical demands. Exercises were applied by a researcher physiotherapist. Receives: Other: Custom Designed Exercises |
| Plates intervention | Experimental | Plates exercises were applied as a group treatment. This exercise type contains non-impact exercises to develop strength, flexibility, balance, and inner awareness.Plates exercises were applied as a group treatment. Exercises were applied by a researcher physiotherapist. Receives: Other: Plates Exercises |
| Chalistenics intervention | Experimental | These exercises included range of motion exercises of neck (flexion, extension, lateral flexion and rotation), shoulder (flexion, extension, abduction, adduction, internal and external rotation), elbow (flexion and extension), forearm (pronation and supination), wrist (flexion and extension), hip (flexion, extension, abduction and adduction, internal and external rotation), knee (flexion and extension), foot (dorsi and plantar flexion, pronation and supination) and trunk (flexion, extension, lateral flexion and rotation). Exercises were applied by a researcher physiotherapist. Receives: Other: Calisthenics Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure after physical performance
Physiological cost index (PCI) calculated during 6 minutes walk test (6MWT) after exercise period. PCI is a clinical tool thought to indicate the energy expenditure. Subjects walk at their preferred pace, usually following a track of known distance, while heart rate and time are noted. After measurement of resting heart rate, a person's PCI in beats per meter is calculated. 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. Mean PCI values for healthy adults have been reported to be between 0.23 and 0.42 beat/meter. The energy consumption increases as the number increases and it indicates fatigue. Lower than 0.23 indicates low energy consumption and is not considered normal.
Measured: 3 months
Quality of life
The 36-Item Short Form Health Survey (SF-36) questionnaire was applied after exercise period. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The test consists of 36 questions and requires 10 minutes to administer. The Sf-36 includes a multi-item scale with 8 subscales. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section.
Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Sections:
Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health.
Measured: 3 months
Secondary outcomes (2)
Timed up and go test
Standing, walking and sitting performance were measured after exercise period by timed up and go test (TUG). TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. ≤10 seconds=normal, ≤ 20 seconds=good mobility, can go out alone, mobile without gait aid, ≤ 30 seconds=problems, can not go outside alone, requires gait aid.
Measured: 3 months
Body mass index
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. It was measured by bioelectrical impedance device.
A BMI below 18.5 is considered underweight. A BMI of 18.5 to 24.9 is considered healthy. A BMI of 25 to 29.9 is considered overweight. A BMI of 30 or higher is considered obese.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start20 Oct 2013
- Primary completion15 Dec 2013
- Study completion16 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Başar Öztürk, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475069
- Sponsor's protocol ID
- drskull78
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Special Exercise Program on Physical Function and Quality of Life Versus Plates and Calisthenics Exercises on Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03475069
- Acronym / sponsor ID
- drskull78
- Conditions
- Type2 Diabetes, Physical Activity
- Keywords
- Type 2 Diabetes Mellitus, Exercise, Physical Performance, Physiological Cost Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 20 Oct 2013 (actual)
- Primary completion
- 15 Dec 2013 (actual)
- Study completion
- 16 Feb 2014 (actual)
- First posted
- 23 Mar 2018 (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.
Type 2 Diabetes Mellitus (DM) is a widespread worldwide disease. Exercise therapy is an effective method but which exercise types are more effective is an important question.
This study was designed to compare the effects of three different exercise programs on physical function and quality of life in Type 2 DM. Forty-two patients with Type 2 DM participated in the study. The patients were randomly assigned to three groups. Client based exercises in accordance with physiotherapy assessment were applied to group 1 (aged 51.42±4.60 years; body mass index 35.28±4.21 kg/m² kg/m²), Clinical Plates exercises were applied to group 2 (aged 53.07 ±5.12 years; body mass index 35.56±4.83 kg/m²) and a standard program including calisthenics exercises were applied to group 3 for 12 weeks, 3 days a week. 6 minutes walk test (6 MWT) and physiological cost index (PCI), timed up and go test (TUG) and SF-36 quality of life questionnaire were performed before and after the 12-week exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual intervention | Experimental | Other: Custom Designed ExercisesThis exercise program was prepared specific to each patient in this group according to his/her physiotherapy assessment, functional performance tests and body analysis results. This exercise type focuses on patients' physical demands. Exercises were applied by a researcher physiotherapist. |
| Plates intervention | Experimental | Other: Plates ExercisesPlates exercises were applied as a group treatment. This exercise type contains non-impact exercises to develop strength, flexibility, balance, and inner awareness.Plates exercises were applied as a group treatment. Exercises were applied by a researcher physiotherapist. |
| Chalistenics intervention | Experimental | Other: Calisthenics ExercisesThese exercises included range of motion exercises of neck (flexion, extension, lateral flexion and rotation), shoulder (flexion, extension, abduction, adduction, internal and external rotation), elbow (flexion and extension), forearm (pronation and supination), wrist (flexion and extension), hip (flexion, extension, abduction and adduction, internal and external rotation), knee (flexion and extension), foot (dorsi and plantar flexion, pronation and supination) and trunk (flexion, extension, lateral flexion and rotation). Exercises were applied by a researcher physiotherapist. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who can walk independently.
- Patients who accept doing exercises for 12 weeks, 3 days a week properly Patients whose cognitive status are enough for understanding and realizing different exercise types.
Key exclusion criteria (5 listed)
- Patients with orthopaedic or surgical problems that prevent walking.
- Patients with neuropathy that prevent walking.
- Patients who have foot ulcers.
- Patients with neurological problems.
- Patients with cardiac, pulmonary and systematic problems that cause contraindication for exercise.
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 |
|---|---|---|
| Custom Designed Exercises | Other | Individual intervention |
| Plates Exercises | Other | Plates intervention |
| Calisthenics Exercises | Other | Chalistenics intervention |
Primary outcome
Energy expenditure after physical performance
Time frame: 3 months
Physiological cost index (PCI) calculated during 6 minutes walk test (6MWT) after exercise period. PCI is a clinical tool thought to indicate the energy expenditure. Subjects walk at their preferred pace, usually following a track of known distance, while heart rate and time are noted. After measurement of resting heart rate, a person's PCI in beats per meter is calculated. 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. Mean PCI values for healthy adults have been reported to be between 0.23 and 0.42 beat/meter. The energy consumption increases as the number increases and it indicates fatigue. Lower than 0.23 indicates low energy consumption and is not considered normal.
Quality of life
Time frame: 3 months
The 36-Item Short Form Health Survey (SF-36) questionnaire was applied after exercise period. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The test consists of 36 questions and requires 10 minutes to administer. The Sf-36 includes a multi-item scale with 8 subscales. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health.
2 secondary outcomes
Timed up and go test
Time frame: 3 months
Body mass index
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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 Custom Designed Exercises, Plates Exercises and Calisthenics Exercises in people with Type2 Diabetes and Physical Activity, run by Biruni University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 Mar 2018. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Energy expenditure after physical performance (time frame: 3 months). The study lists 2 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 30 Mar 2018.