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Which Exercises Should Diabetic Patients do?

Primary Purpose

Type2 Diabetes, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Custom Designed Exercises
Plates Exercises
Calisthenics Exercises
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring Type 2 Diabetes Mellitus, Exercise, Physical Performance, Physiological Cost Index

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Başar Öztürk

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Individual intervention

Plates intervention

Chalistenics intervention

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 9, 2018
Last Updated
March 28, 2018
Sponsor
Biruni University
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03475069
Brief Title
Which Exercises Should Diabetic Patients do?
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 20, 2013 (Actual)
Primary Completion Date
December 15, 2013 (Actual)
Study Completion Date
February 16, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
Collaborators
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Physical Activity
Keywords
Type 2 Diabetes Mellitus, Exercise, Physical Performance, Physiological Cost Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Plates intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Chalistenics intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Custom Designed Exercises
Intervention Type
Other
Intervention Name(s)
Plates Exercises
Intervention Type
Other
Intervention Name(s)
Calisthenics Exercises
Primary Outcome Measure Information:
Title
Energy expenditure after physical performance
Description
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.
Time Frame
3 months
Title
Quality of life
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Timed up and go test
Description
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.
Time Frame
3 months
Title
Body mass index
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Başar Öztürk
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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