- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03475069
Which Exercises Should Diabetic Patients do?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Başar Öztürk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Individual intervention
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.
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Experimental: Plates intervention
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.
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Experimental: Chalistenics intervention
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure after physical performance
Time Frame: 3 months
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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.
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3 months
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Quality of life
Time Frame: 3 months
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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. |
3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed up and go test
Time Frame: 3 months
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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.
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3 months
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Body mass index
Time Frame: 3 months
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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. |
3 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- drskull78
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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