HypertensionNCT03254251
The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women
A study testing Stair climbing in people with Hypertension and Menopause, run by Pusan National University.
Trial summary
We used a parallel experimental design. Following an initial screening and familiarization session of study tests and procedures, eligible postmenopausal women were randomly assigned to a stair climbing (SC) group or non-exercising control group. Read more about this study
- Who is it for?
- Ages 58 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Menopause
- What is being tested?
- Stair climbing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 10 Apr 2017
- Phase
- Interventional
- 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 58 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Stage-1 hypertension
- Postmenopausal
Who cannot join
- Pulmonary, renal, adrenal, pituitary, severe psychiatric, thyroid, or cardiovascular disease other than stage-1 systolic hypertension (140-159 mmHg)
- Hormone replacement therapy during the 6 months prior the study
- Smoker or having any medication changes in the previous year
- Experience with psychological and physical therapy in the previous year
- History of steady exercise or exercise training in the last year
About this study
Official title: The Effects of a 12-week Stair Climbing Regimen on Arterial Stiffness, BP and Leg Strength in Stage-1 Hypertensive Postmenopausal Women
We used a parallel experimental design. Following an initial screening and familiarization session of study tests and procedures, eligible postmenopausal women were randomly assigned to a stair climbing (SC) group or non-exercising control group. SC training session was progressive program, and was performed 4 days a week for 12 weeks. Measurements were collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48 and 72 hours after the last exercise session.
- Conditions
- Hypertension, Menopause
- Being tested
- Stair climbing
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stair climbingBehavioural
Stair climbing (SC) training was 12 weeks of progressive SC program. Each training session consisted of a general warm-up (5 min: slow and fast skipping, stretching) followed by the SC training and was supervised by experienced personnel. The program began with two bouts of stair climbing four days a week in weeks 1 and 2, increasing by one climb a day every three weeks. By the last three weeks (10-12) of the study, all subjects were completing 5 climbs four days a week. During each climb participants ascended 12 flights (192 steps) divided into 3 sets of 4 flights, with a 2 min rest period between each set. There was a 5 min rest period between climbs that allowed the participants to reach the ground floor using an elevator. Subjects in the non-exercising control group did not participate in a supervised exercise program for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Stair Climbing (SC) | Experimental | N=20, 12 weeks of stair climbing exercise training. Receives: Behavioral: Stair climbing |
| No Exercise (CON) | No intervention | N=21, No exercise for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Arterial stiff ness was measured by brachial to ankle pulse wave velocity (baPWV, m/s) using volume plethysmographic device (VP-1000).
Measured: 12 weeks
Blood pressure (BP)
BP (mmHg) was measured by volume plethysmographic device. Diastolic blood pressure and systolic blood pressure were measured.
Measured: 12 weeks
Muscle strength
Muscle strength was measured by the eight repetition maximum (8RM) test using extension machine (Cyber 6000).
Measured: 12 weeks
Body composition
Body composition was measured using eight-polar tactile-electrode impedance meter (InBody 720). Body weight (kg), fat mass (kg), and fat free mass (kg) were assessed.
Measured: 12 weeks
Height
Height (m) was measured with a stadiometer
Measured: 12 weeks
Heart rate (HR)
Heart rate was measured by ECG
Measured: 12 weeks
Body mass index (BMI)
BMI was calculated as weight/height^2 (kg/m^2)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start9 Jan 2017
- Primary completion3 Apr 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-Eui University, University of Nebraska
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254251
- Sponsor's protocol ID
- PusanNU-3
- Status last verified
- Oct 2020
- First submitted
- 16 Aug 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong A, Figueroa A, Son WM, Chernykh O, Park SY. The effects of stair climbing on arterial stiffness, blood pressure, and leg strength in postmenopausal women with stage 2 hypertension. Menopause. 2018 Jul;25(7):731-737. doi: 10.1097/GME.0000000000001072.
PubMed 29438269
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a 12-week Stair Climbing Regimen on Arterial Stiffness, BP and Leg Strength in Stage-1 Hypertensive Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03254251
- Acronym / sponsor ID
- PusanNU-3
- Conditions
- Hypertension, Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Dong-Eui University, University of Nebraska
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 18 Aug 2017 (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.
We used a parallel experimental design. Following an initial screening and familiarization session of study tests and procedures, eligible postmenopausal women were randomly assigned to a stair climbing (SC) group or non-exercising control group. SC training session was progressive program, and was performed 4 days a week for 12 weeks. Measurements were collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48 and 72 hours after the last exercise session.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stair Climbing (SC) | Experimental | Behavioral: Stair climbingN=20, 12 weeks of stair climbing exercise training. |
| No Exercise (CON) | No intervention | –N=21, No exercise for 12 weeks |
Who may qualify
- Ages
- 58 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Stage-1 hypertension
- Postmenopausal
Key exclusion criteria (5 listed)
- Pulmonary, renal, adrenal, pituitary, severe psychiatric, thyroid, or cardiovascular disease other than stage-1 systolic hypertension (140-159 mmHg)
- Hormone replacement therapy during the 6 months prior the study
- Smoker or having any medication changes in the previous year
- Experience with psychological and physical therapy in the previous year
- History of steady exercise or exercise training in the last year
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 |
|---|---|---|
| Stair climbingStair climbing (SC) training was 12 weeks of progressive SC program. Each training session consisted of a general warm-up (5 min: slow and fast skipping, stretching) followed by the SC training and was supervised by experienced personnel. The program began with two bouts of stair climbing four days a week in weeks 1 and 2, increasing by one climb a day every three weeks. By the last three weeks (10-12) of the study, all subjects were completing 5 climbs four days a week. During each climb participants ascended 12 flights (192 steps) divided into 3 sets of 4 flights, with a 2 min rest period between each set. There was a 5 min rest period between climbs that allowed the participants to reach the ground floor using an elevator. Subjects in the non-exercising control group did not participate in a supervised exercise program for the duration of the study. | Behavioural | Stair Climbing (SC) |
Primary outcome
Arterial stiffness
Time frame: 12 weeks
Arterial stiff ness was measured by brachial to ankle pulse wave velocity (baPWV, m/s) using volume plethysmographic device (VP-1000).
Blood pressure (BP)
Time frame: 12 weeks
BP (mmHg) was measured by volume plethysmographic device. Diastolic blood pressure and systolic blood pressure were measured.
Muscle strength
Time frame: 12 weeks
Muscle strength was measured by the eight repetition maximum (8RM) test using extension machine (Cyber 6000).
Body composition
Time frame: 12 weeks
Body composition was measured using eight-polar tactile-electrode impedance meter (InBody 720). Body weight (kg), fat mass (kg), and fat free mass (kg) were assessed.
Height
Time frame: 12 weeks
Height (m) was measured with a stadiometer
Heart rate (HR)
Time frame: 12 weeks
Heart rate was measured by ECG
Body mass index (BMI)
Time frame: 12 weeks
BMI was calculated as weight/height^2 (kg/m^2)
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 3 Nov 2020.
- Derived from this study: PubMed 29438269Wong A, Figueroa A, Son WM, Chernykh O, Park SY. The effects of stair climbing on arterial stiffness, blood pressure, and leg strength in postmenopausal women with stage 2 hypertension. Menopause. 2018 Jul;25(7):731-737. doi: 10.1097/GME.0000000000001072.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stair climbing in people with Hypertension and Menopause, run by Pusan National University.
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 5 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Arterial stiffness (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03254251, which also lists 1 linked publication.
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 3 Nov 2020.