Which Exercises Should Diabetic Patients do?

NCT03475069 | Completed

• 1 other identifier: drskull78
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes; Physical Activity

Keywords

Type 2 Diabetes Mellitus; Exercise; Physical Performance; Physiological Cost Index

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Timed up and go test

  3 months

• Body mass index

  3 months

Study Arms (3)

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.

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.

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.

Other: Calisthenics Exercises

Interventions

Custom Designed Exercises OTHER

Individual intervention

Plates Exercises OTHER

Plates intervention

Calisthenics Exercises OTHER

Chalistenics intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead
• Hacettepe University: collaborator

Study Sites (1)

Başar Öztürk

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 23, 2018
• Study Start: October 20, 2013
• Primary Completion: December 15, 2013
• Study Completion: February 16, 2014
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

TU (1)