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NCT Number: NCT06519318

Validity And Reliability of The Incremental Shuttle Walk Test In 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Reliability and Validity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Foundation University Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incremental Shuttle Walk Test

    Time frame: 15 minute

    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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ilayda Kayapinar

Other

Collaborators

  • Bezmialem Vakif University
  • Istanbul University - Cerrahpasa

Registry information

Official study title

Validity And Reliability of The Incremental Shuttle Walk Test In Individuals With Type 2 Diabetes Mellitus

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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