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Clinical Trials/NCT03475069
NCT03475069
Completed
N/A

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

Biruni University1 site in 1 country42 target enrollmentOctober 20, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type2 Diabetes
Sponsor
Biruni University
Enrollment
42
Locations
1
Primary Endpoint
Energy expenditure after physical performance
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2013
End Date
February 16, 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Biruni University
Responsible Party
Principal Investigator
Principal Investigator

Başar Öztürk

Assistant Professor

Biruni University

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Timed up and go test(3 months)
  • Body mass index(3 months)

Study Sites (1)

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