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Validity of 6 Minutes Stepper Test in Hypertension

Sponsor
Ebru Calik Kutukcu (Other)
Overall Status
Completed
CT.gov ID
NCT06087172
Collaborator
(none)
40
Enrollment
1
Location
6
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Six Minutes Stepper Test (6MST)

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Validity and Reliability of 6 Minutes Stepper Test in Hypertensive Patients
Actual Study Start Date :
Jun 1, 2022
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Hypertensive Individuals

Patients diagnosed with arterial hypertension

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. exercise capacity [through study completion two day]

      steps during 6MST

    2. functional capacity [through study completion two day]

      walking distance during 6MWT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University Ankara Turkey

    Sponsors and Collaborators

    • Ebru Calik Kutukcu

    Investigators

    • Study Chair: Ebru Calik Kutukcu, PhD, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ebru Calik Kutukcu, Associate Professor, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT06087172
    Other Study ID Numbers:
    • GO 22/388
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ebru Calik Kutukcu, Associate Professor, Hacettepe University
    Stepper Test
    Exercise Capacity
    Cardiac Rehabilitation
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Oct 17, 2023