Validity of 6 Minutes Stepper Test in Hypertension

October 13, 2023 updated by: Ebru Calik Kutukcu

Validity and Reliability of 6 Minutes Stepper Test in Hypertensive Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Diagnosed with systemic (arterial) hypertension and convenient with inclusion and exclusion criterias.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exercise capacity
Time Frame: through study completion two day
steps during 6MST
through study completion two day
functional capacity
Time Frame: through study completion two day
walking distance during 6MWT
through study completion two day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ebru Calik Kutukcu

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 22/388

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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