Clinical trial NCT06519318: Validity And Reliability of The Incremental Shuttle Walk Test In Type 2 Diabetes Mellitus
Official title: Validity And Reliability of The Incremental Shuttle Walk Test In Individuals With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes Mellitus
Reliability and Validity
Keywords: Diabetes Mellitus
6-Minute Walk Test
Incremental Shuttle Walk Test
Reliability and Validity
Lead sponsor: Istanbul Rumeli University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: Bezmialem Vakif University
First posted: 2024-07-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-65 years with type 2 diabetes mellitus

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incremental Shuttle Walk Test
timeFrame: 15 minute
Secondary outcomes:
measure: Six Minute Walking Test
timeFrame: 10 minute
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Kent Universty
name: Melis USUL, RA
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Galata Universty
name: Gülenay YILDIRIM, RA
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Universty-Cerrahpaşa
name: Gökşen KURAN ASLAN, Prof
role: STUDY_DIRECTOR
affiliation: Bezmaialem Foundation University
name: Semiramis Özyılmaz, Assoc Prof
role: STUDY_DIRECTOR
affiliation: Bezmaialem Foundation University
name: Muhammed TUNÇ, Asst Prof
role: STUDY_DIRECTOR
References: