NCT06087172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

September 17, 2023

Last Update Submit

October 13, 2023

Conditions

Arterial HypertensionHypertension

Keywords

Stepper TestExercise CapacityCardiac Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • exercise capacity

    steps during 6MST

    through study completion two day

  • functional capacity

    walking distance during 6MWT

    through study completion two day

Study Arms (1)

Hypertensive Individuals

Patients diagnosed with arterial hypertension

Diagnostic Test: Six Minutes Stepper Test (6MST)

Interventions

Six Minutes Stepper Test (6MST)DIAGNOSTIC_TEST

Patients were applied two 6MST and 6MWT. 6MWT was conducted to test convergent validity of 6MST.

Also known as: Six Minutes Walking Test (6MWD)
Hypertensive Individuals

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Being 18 to 65 years,
  • Diagnosed with hypertension and willing to participate the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ebru Calik Kutukcu, PhD

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 17, 2023

First Posted

October 17, 2023

Study Start

June 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

TU(1)