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

NCT06519318 | Completed DMC

• 1 other identifier: 2024/272
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Reliability and Validity

Keywords

Diabetes Mellitus; 6-Minute Walk Test; Incremental Shuttle Walk Test; Reliability and Validity

Outcome Measures

Primary Outcomes (1)

• Incremental Shuttle Walk Test

  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.

  15 minute

Secondary Outcomes (1)

• Six Minute Walking Test

  10 minute

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-65 years with type 2 diabetes mellitus

You may qualify if:

• HbA1c between 6.5 and 11
• No mental problems
• Able to walk independently

You may not qualify if:

• 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

Sponsors & Collaborators

• Ilayda Kayapinar: lead
• Bezmialem Vakif University: collaborator
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Bezmialem Foundation University Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Melis USUL, RA

  Istanbul Kent Universty

  PRINCIPAL INVESTIGATOR

• Gülenay YILDIRIM, RA

  Istanbul Galata Universty

  PRINCIPAL INVESTIGATOR

• Gökşen KURAN ASLAN, Prof

  Istanbul Universty-Cerrahpaşa

  STUDY DIRECTOR

• Semiramis Özyılmaz, Assoc Prof

  Bezmaialem Foundation University

  STUDY DIRECTOR

• Muhammed TUNÇ, Asst Prof

  Bezmaialem Foundation University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: March 30, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)