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NCT06087172 Clinical Trial

Validity of 6 Minutes Stepper Test in Hypertension

Hypertension Clinical Trial

Official title:
Validity and Reliability of 6 Minutes Stepper Test in Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06087172
Other study ID # GO 22/388
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date December 1, 2022

Study information
Verified date October 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The six minutes stepper test (6MST) was used assess exercise capacity of individuals having different chronic conditions. In the literature, there are some validation studies analyzing validity of 6MST. In this study, the main aim was to analyse validation of 6MST in hypertensive individuals.

Description:

6MST is a space-safe, feasible and sensitive test to assess exercise capacity. In the literature, there are lots of field tests assessing exercise capacity of individuals with chronic status. But common field tests eg 6MWT requires long spaces and it could become an important barrier in clinical settings. Hypertension is a common chronic disease and hypertensive individuals are important candidates of cardiac rehabilitation. As an important outcome assesing exercise capacity are very important before and after cardiac rehabilitation. In this study, the main aim was to investigate reliability and validity of 6MST in systemic hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criterias: - Being 18 to 65 years, - Diagnosed with hypertension and willing to participate the study. Exclusion Criterias: - having a neurological, cognitive and/or orthopedic disease that affect the measurements, - severe respiratory disease (FEV1 < 35%; FVC < 50%), - presence of acute infection, - any malignancy, - dementia, - any cardiovascular event in the last 6 months, - uncontrolled hypertension and diabetes - body mass index (BMI) higher than 40 kg/m2

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Six Minutes Stepper Test (6MST)
Patients were applied two 6MST and 6MWT. 6MWT was conducted to test convergent validity of 6MST.

Locations
Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ebru Calik Kutukcu

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary exercise capacity steps during 6MST through study completion two day
Primary functional capacity walking distance during 6MWT through study completion two day
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