MenopauseNCT03546270
The Effects of Swimming on Elderly Women With Stage-2 Hypertension
A study testing Swimming in people with Menopause and Hypertension, run by Pusan National University.
Trial summary
Aging is associated with progressive decreases in arterial health and function as well as overall fitness. It is crucial to prevent or reduce the negative effects of aging on the vasculature and fitness components by implementing appropriate lifestyle interventions, such as exercise training. Read more about this study
- Who is it for?
- Ages 65 to 85 years, women only
- Conditions the study is for
- Menopause, Hypertension
- What is being tested?
- Swimming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 85 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- systolic/diastolic BP: 140-179 over 90-119 mm Hg
- had experienced the absence of menstruation for at least 1 year
- body mass index <30 kg/m2
- <1 h of regular exercise per week in the previous year
Who cannot join
- Smoker
- Taking any medications or hormone therapy in previous year
About this study
Official title: The Effects of Swimming Training on Arterial Function, Strength and Cardiorespiratory Capacity in Elderly Women With Stage 2 Hypertension
Aging is associated with progressive decreases in arterial health and function as well as overall fitness. It is crucial to prevent or reduce the negative effects of aging on the vasculature and fitness components by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a swimming (SWM) regimen on arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), wave reflection (AIx), muscle strength and aerobic capacity in elderly women with stage 2 hypertension.
Read the detailed description
Using a parallel experimental design, participants were randomly assigned to either SWM (n=52) or non-exercising control group (n=48) for 20 weeks. Participant in the SWM group trained 3-4 days/week, progressing in duration from 25 to 45 min. Participants' carotid to radial PWV (crPWV), systolic and diastolic BP, AIx, strength and VO2max were measured at baseline and after 20 weeks of their assigned intervention.
- Conditions
- Menopause, Hypertension
- Being tested
- Swimming
- Keywords
- Swimming, Arterial Stiffness, Blood Pressure, Muscular Strength, Cardiorespiratory Endurance
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwimmingBehavioural
This group completed 20-weeks of swimming
| Study group | Role | What they receive |
|---|---|---|
| Swimming | Experimental | Participants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at ~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate Receives: Behavioral: Swimming |
| Control | No intervention | Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
via Pulse Wave Velocity
Measured: 20-weeks
Secondary outcomes (5)
Systolic Blood Pressure
systolic blood pressure
Measured: 20-weeks
Pressure Wave Reflection
via Augmentation Index
Measured: 20-weeks
Muscular Strength
via Hand Grip Dynamometer
Measured: 20-weeks
Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)
via Cornell Modified Bruce treadmill volume of oxygen consumption maximum (VO2max) test
Measured: 20-weeks
Diastolic Blood Pressure
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study startJan 2017
- Primary completionJan 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Marymount University, Dong-Eui University, University of Nebraska
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546270
- Sponsor's protocol ID
- SwimmingMenopause
- Status last verified
- Oct 2020
- First submitted
- 22 May 2018
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong A, Kwak YS, Scott SD, Pekas EJ, Son WM, Kim JS, Park SY. The effects of swimming training on arterial function, muscular strength, and cardiorespiratory capacity in postmenopausal women with stage 2 hypertension. Menopause. 2018 Dec 17;26(6):653-658. doi: 10.1097/GME.0000000000001288.
PubMed 30562322
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Swimming Training on Arterial Function, Strength and Cardiorespiratory Capacity in Elderly Women With Stage 2 Hypertension
- ClinicalTrials.gov ID
- NCT03546270
- Acronym / sponsor ID
- SwimmingMenopause
- Conditions
- Menopause, Hypertension
- Keywords
- Swimming, Arterial Stiffness, Blood Pressure, Muscular Strength, Cardiorespiratory Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Marymount University, Dong-Eui University, University of Nebraska
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aging is associated with progressive decreases in arterial health and function as well as overall fitness. It is crucial to prevent or reduce the negative effects of aging on the vasculature and fitness components by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a swimming (SWM) regimen on arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), wave reflection (AIx), muscle strength and aerobic capacity in elderly women with stage 2 hypertension.
Detailed description
Using a parallel experimental design, participants were randomly assigned to either SWM (n=52) or non-exercising control group (n=48) for 20 weeks. Participant in the SWM group trained 3-4 days/week, progressing in duration from 25 to 45 min. Participants' carotid to radial PWV (crPWV), systolic and diastolic BP, AIx, strength and VO2max were measured at baseline and after 20 weeks of their assigned intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swimming | Experimental | Behavioral: SwimmingParticipants performed SWM training (combination of free style, breast stroke, and backstroke) for 20 weeks. For the first 5 weeks subjects swam 25-30 minutes/day, 3-4 days/week at ~60% of maximal heart rate. As their overall level of fitness and exercise skill improved, the intensity and duration of exercise increased to 40-45 minutes/day, 3-4 days/week at an intensity of 70-75% of the HRmax. Target HR was adjusted based on the observation that maximal heart rate during SWM is approximately 12 beats/min lower than that during running. Each subject was instructed to swim continuously except during the time needed for checking a target heart rate |
| Control | No intervention | –Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- systolic/diastolic BP: 140-179 over 90-119 mm Hg
- had experienced the absence of menstruation for at least 1 year
- body mass index <30 kg/m2
- <1 h of regular exercise per week in the previous year
Key exclusion criteria (2 listed)
- Smoker
- Taking any medications or hormone therapy in previous 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 |
|---|---|---|
| SwimmingThis group completed 20-weeks of swimming | Behavioural | Swimming |
Primary outcome
Arterial Stiffness
Time frame: 20-weeks
via Pulse Wave Velocity
5 secondary outcomes
Systolic Blood Pressure
Time frame: 20-weeks
Pressure Wave Reflection
Time frame: 20-weeks
Muscular Strength
Time frame: 20-weeks
Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)
Time frame: 20-weeks
Diastolic Blood Pressure
Time frame: 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30562322Wong A, Kwak YS, Scott SD, Pekas EJ, Son WM, Kim JS, Park SY. The effects of swimming training on arterial function, muscular strength, and cardiorespiratory capacity in postmenopausal women with stage 2 hypertension. Menopause. 2018 Dec 17;26(6):653-658. doi: 10.1097/GME.0000000000001288.
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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 Swimming in people with Menopause and Hypertension, 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 4 inclusion and 2 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 18 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?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 20-weeks). 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 NCT03546270, 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 18 Nov 2020.