Arterial HypertensionNCT06087172
Validity of 6 Minutes Stepper Test in Hypertension
An observational study of Arterial Hypertension and Hypertension, run by Ebru Calik Kutukcu at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arterial Hypertension, Hypertension
- What is being tested?
- Six Minutes Stepper Test (6MST)
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Diagnosed with systemic (arterial) hypertension and convenient with inclusion and exclusion criterias.
Who may be able to join
- Being 18 to 65 years,
- Diagnosed with hypertension and willing to participate the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Arterial Hypertension, Hypertension
- Being tested
- Six Minutes Stepper Test (6MST)
- Keywords
- Stepper Test, Exercise Capacity, Cardiac Rehabilitation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six Minutes Stepper Test (6MST)Diagnostic test
Also called Six Minutes Walking Test (6MWD)
Patients were applied two 6MST and 6MWT. 6MWT was conducted to test convergent validity of 6MST.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive Individuals | Patients diagnosed with arterial hypertension Receives: Diagnostic Test: Six Minutes Stepper Test (6MST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
steps during 6MST
Measured: through study completion two day
functional capacity
walking distance during 6MWT
Measured: through study completion two day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Jun 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebru Calik Kutukcu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, PhD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087172
- Sponsor's protocol ID
- GO 22/388
- Status last verified
- Oct 2023
- First submitted
- 17 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of 6 Minutes Stepper Test in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06087172
- Acronym / sponsor ID
- GO 22/388
- Conditions
- Arterial Hypertension, Hypertension
- Keywords
- Stepper Test, Exercise Capacity, Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ebru Calik KutukcuUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive Individuals | – | Diagnostic Test: Six Minutes Stepper Test (6MST)Patients diagnosed with arterial hypertension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with systemic (arterial) hypertension and convenient with inclusion and exclusion criterias.
Key inclusion criteria (2 listed)
- Being 18 to 65 years,
- Diagnosed with hypertension and willing to participate the study.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six Minutes Stepper Test (6MST)Also: Six Minutes Walking Test (6MWD)Patients were applied two 6MST and 6MWT. 6MWT was conducted to test convergent validity of 6MST. | Diagnostic test | Hypertensive Individuals |
Primary outcome
exercise capacity
Time frame: through study completion two day
steps during 6MST
functional capacity
Time frame: through study completion two day
walking distance during 6MWT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
Related trials for Arterial Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Calik Kutukcu, PhD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension and Hypertension, run by Ebru Calik Kutukcu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise capacity (time frame: through study completion two day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.