- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06519318
Validity And Reliability of The Incremental Shuttle Walk Test In Type 2 Diabetes Mellitus
Validity And Reliability of The Incremental Shuttle Walk Test In Individuals With Type 2 Diabetes Mellitus
The aim of our study was to determine the validity and reliability of the incremental shuttle walk test (ISWT) in patients with type 2 diabetes mellitus.This study involves the evaluation of the validity and test-retest reliability of the ISWT.
The assessments will be performed in two separate time periods. At the first visit, baseline assessments of the patient will be performed. These assessments include the recording of demographic information and the ISWT and 6 minute walk test assessments. Both tests will be performed with a 30-minute interval between them.
A retest will be performed 1 week after the initial assessment.
Study Overview
Status
Conditions
Detailed Description
Diabetes mellitus is a hormonal, metabolic and chronic disease characterised by hyperglycaemia resulting from a partial or complete deficiency of the hormone insulin or a defect in insulin-sensing receptors. Functional capacity is a vital marker for many chronic diseases, including Type 2 diabetes. Many things about the mechanism of decreased functional capacity specific to individuals with type 2 diabetes have not yet been clarified. As a result of the researches, it has been concluded that the deterioration in functional capacity is mostly related to glycaemic control and complications.
The Incremental Shuttle Walk Test (ISWT) is a maximal test that is widely used for the assessment of functional capacity and exercise tolerance because it is low cost and easy to perform. The incremental speed shuttle walk test was first described in 1992 to assess exercise capacity in patients with COPD. Compared to other field tests, ISWT is recommended because it shows high levels of maximum oxygen uptake (peak VO2) and provides physiological results closest to cardiopulmonary exercise testing (CPET), which is considered as the gold standard in the assessment of functional capacity.
The aim of our study was to determine the validity and reliability of the increasing speed shuttle walking test in patients with type 2 diabetes mellitus.
This study involves the evaluation of the validity and test-retest reliability of the ISWT.
The assessments will be performed in two separate time periods. At the first visit, baseline assessments of the patient will be performed. These assessments include the recording of demographic information and the ISWT and 6 minute walk test assessments. Both tests will be performed with a 30-minute interval between them.
A retest will be performed 1 week after the initial assessment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Bezmialem Foundation University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- HbA1c between 6.5 and 11
- No mental problems
- Able to walk independently
Exclusion Criteria:
- Lack of co-operation
- Uncontrolled diabetes,
- Patients with uncontrolled hypotension or hypertension
- Unstable cardiovascular and pulmonary conditions
- Having vertigo and various vestibular system disorders
- Those with severe neurological or severe respiratory diseases
- Patients with major musculoskeletal problems
- Pregnant women
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incremental Shuttle Walk Test
Time Frame: 15 minute
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For the reliability of the incremental shuttle walk test at the retest will be performed in 1 week.
It is a field test consisting of 12 levels in which walking speed is increased.
It is based on the principle of walking with an acceleration at an increasing speed in the up and down direction by passing around the cones on a 10-meter track with a distance of 9 metres between two cones by accepting turns around the cones as 0.5 meters.
The distance covered is recorded during the test period.
The increase in speed every minute is determined by three consecutive signals and only verbal warnings are given so that the individual can catch up with the speed during the test.
If the individual is unable to continue the test (reaching maximal heart rate, pain, SpO2 value <80% extreme dyspnoea, fatigue), the test is terminated and the distance is recorded.
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15 minute
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six Minute Walking Test
Time Frame: 10 minute
|
The validity of the incremental shuttle test will be determined by 6 minute walking test.
The test is performed in a thirty metre corridor.
The distance walked over 30 meters for 6 minutes is recorded.
Heart rate, dyspnoea level using the Borg scale, blood pressure and oxyhaemoglobin saturation can be determined before and after the test.
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10 minute
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melis USUL, RA, Istanbul Kent Universty
- Principal Investigator: Gülenay YILDIRIM, RA, Istanbul Galata Universty
- Study Director: Gökşen KURAN ASLAN, Prof, Istanbul Universty-Cerrahpaşa
- Study Director: Semiramis Özyılmaz, Assoc Prof, Bezmaialem Foundation University
- Principal Investigator: Muhammed TUNÇ, Asst Prof, Bezmaialem Foundation University
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/272
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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