Which Exercises Should Diabetic Patients do?

Physical Activity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475069
• Other study ID #: drskull78
• Status: Completed
• Phase: N/A
• First received: March 9, 2018
• Last updated: March 28, 2018
• Start date: October 20, 2013
• Est. completion date: February 16, 2014

Study information

• Verified date: March 2018
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 16, 2014
• Est. primary completion date: December 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Physical Activity
• Type2 Diabetes

Intervention

Other:
• Custom Designed Exercises

• Plates Exercises

• Calisthenics Exercises

Locations

Country	Name	City	State
Turkey	Basar Öztürk	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Biruni University	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months