- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03254251
The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women
October 30, 2020 updated by: Won-mok son, Pusan National University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
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
58 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Stage-1 hypertension
- Postmenopausal
Exclusion Criteria:
- 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
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stair Climbing (SC)
N=20, 12 weeks of stair climbing exercise training.
|
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.
|
|
No Intervention: No Exercise (CON)
N=21, No exercise for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
12 weeks
|
|
Blood pressure (BP)
Time Frame: 12 weeks
|
BP (mmHg) was measured by volume plethysmographic device.
Diastolic blood pressure and systolic blood pressure were measured.
|
12 weeks
|
|
Muscle strength
Time Frame: 12 weeks
|
Muscle strength was measured by the eight repetition maximum (8RM) test using extension machine (Cyber 6000).
|
12 weeks
|
|
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.
|
12 weeks
|
|
Height
Time Frame: 12 weeks
|
Height (m) was measured with a stadiometer
|
12 weeks
|
|
Heart rate (HR)
Time Frame: 12 weeks
|
Heart rate was measured by ECG
|
12 weeks
|
|
Body mass index (BMI)
Time Frame: 12 weeks
|
BMI was calculated as weight/height^2 (kg/m^2)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 9, 2017
Primary Completion (Actual)
April 3, 2017
Study Completion (Actual)
April 10, 2017
Study Registration Dates
First Submitted
August 16, 2017
First Submitted That Met QC Criteria
August 16, 2017
First Posted (Actual)
August 18, 2017
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
October 30, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- PusanNU-3
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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