Cardiovascular DiseasesGS3NCT04290637
The Galway Sea Swimmers Study
A study testing Cold-water sea swimming and No cold-water sea swimming in people with Cardiovascular Diseases and Hypertension, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
Cardiovascular disease (CVD) is the leading cause of death worldwide. Hypertension is a well-established risk factor for the development of CVD. Lifestyle modifications, including exercise, remain the cornerstone of blood pressure (BP)-lowering strategy. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension
- What is being tested?
- Cold-water sea swimming and No cold-water sea swimming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2020to Oct 2021
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- habitual swimmers (i.e., sea swimming at least 2 times/week for the past year)
- 18 years of age or older
- able to provide informed consent
Who cannot join
- underlying cardiac (e.g., self-reported heart failure) or pulmonary diseases (e.g., self-reported chronic obstructive pulmonary disease)
- recent orthopedic procedures (e.g., joint replacement therapy)
- severe disabling comorbidity
- recent arm (both arms) or chest wall injury
- pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Galway Sea Swimmers Study: A Randomized Study of the Effect of Cold-Water Sea Swimming on Cardiovascular Risk Factors
Cardiovascular disease (CVD) is the leading cause of death worldwide. Hypertension is a well-established risk factor for the development of CVD. Lifestyle modifications, including exercise, remain the cornerstone of blood pressure (BP)-lowering strategy. Swimming has long been a popular recreational activity for exercise, and is recently gaining widespread recognition as an effective option in maintaining and improving cardiovascular health. Previous studies that involved pool swimming as an intervention (versus no pool swimming) demonstrated favorable benefits of the former on BP reduction. However, no studies to date have specifically investigated the effect of cold-water sea swimming on BP. Indeed, the naturally lower water temperature in the sea may engender a 'cold water immersion' experience in sea swimmers with subsequent stress physiology, which have been shown to exert unique effects on cardiovascular hemodynamics. This study primarily aims to determine the impact of cold-water sea swimming on BP in a group of habitual sea swimmers in Galway who will be randomly assigned to either continue or stop swimming for 4-6 weeks. Other objective and subjective health benefits to sea swimming will also be explored in this study. Given the ubiquitous nature of this activity in the Irish general public, particularly in Galway, this study has potential from a public health perspective, and would add to the literature base pertaining to the benefits of sea swimming on cardiovascular health.
Read the detailed description
Consenting participants will be randomly assigned, 1:1, to either continuation of sea swimming or discontinuation of sea swimming for 4-6 weeks, stratified by the type of swimmer (those who purely immerse in the water for a brief period of time versus those who actually swim [i.e., exercise] in the water) and use of blood pressure medication at the time of study commencement (yes or no), using a block size of four to maintain balance between intervention arms. In line with previous studies that assessed the impact of swimming intervention on BP, participants randomized to the swimming arm should pursue sea swimming 2 or more days/week.
- Conditions
- Cardiovascular Diseases, Hypertension
- Being tested
- Cold-water sea swimming, No cold-water sea swimming
- Keywords
- Cardiovascular Diseases, Cardiac Disease, Heart Diseases, Hypertension, Blood Pressure, Swimming, Exercise, Vascular Stiffness, Pulse Wave Analysis, Health-Related Quality Of Life, Heart Rate Variability, Immersion
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Heart Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-water sea swimmingOther
Continue sea swimming for 4-6 weeks
No cold-water sea swimmingOther
Discontinue sea swimming for 4-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| No sea swimming | Experimental | Stop sea swimming for 4-6 weeks Receives: Other: No cold-water sea swimming |
| Sea swimming | Active comparator | Continue sea swimming for 4-6 weeks Receives: Other: Cold-water sea swimming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean systolic blood pressure
Systolic blood pressure recorded using a 24-hour ambulatory blood pressure monitor
Measured: Measured at baseline and again at 6 weeks
Secondary outcomes (5)
Change in Pulse Wave Velocity
Pulse wave velocity measured using Complior Device
Measured: Measured at baseline and 6 weeks
Change in Augmentation index
Augmentation index measured using Complior device
Measured: Measured at baseline and 6 weeks
Change in Heart rate variability
Measured using 24-hour ambulatory blood pressure monitor
Measured: Measured at baseline and 6 weeks
Change in Health-related quality of life
Measure using EQ-VAS (visual analog scale) instrument. Values between 0 (worst imaginable health) and 100 (best imaginable health)
Measured: Administered at baseline and 6 weeks
Change in mean diastolic blood pressure
Diastolic blood pressure recorded using a 24-hour ambulatory blood pressure monitor
Measured: Measured at baseline and again at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study startOct 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: Unable to recruit during COVID-19 crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. John William McEvoy, National University of Ireland, Galway, Ireland
- Investigators
- John William McEvoy, MBBCh MHS, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290637
- Sponsor's protocol ID
- C.A. 2327
- Acronym
- GS3
- Status last verified
- Apr 2020
- First submitted
- 24 Feb 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Galway Sea Swimmers Study: A Randomized Study of the Effect of Cold-Water Sea Swimming on Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT04290637
- Acronym / sponsor ID
- GS3 / C.A. 2327
- Conditions
- Cardiovascular Diseases, Hypertension
- Keywords
- Cardiovascular Diseases, Cardiac Disease, Heart Diseases, Hypertension, Blood Pressure, Swimming, Exercise, Vascular Stiffness
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Unable to recruit during COVID-19 crisis
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 2 Mar 2020 (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.
Cardiovascular disease (CVD) is the leading cause of death worldwide. Hypertension is a well-established risk factor for the development of CVD. Lifestyle modifications, including exercise, remain the cornerstone of blood pressure (BP)-lowering strategy. Swimming has long been a popular recreational activity for exercise, and is recently gaining widespread recognition as an effective option in maintaining and improving cardiovascular health. Previous studies that involved pool swimming as an intervention (versus no pool swimming) demonstrated favorable benefits of the former on BP reduction. However, no studies to date have specifically investigated the effect of cold-water sea swimming on BP. Indeed, the naturally lower water temperature in the sea may engender a 'cold water immersion' experience in sea swimmers with subsequent stress physiology, which have been shown to exert unique effects on cardiovascular hemodynamics. This study primarily aims to determine the impact of cold-water sea swimming on BP in a group of habitual sea swimmers in Galway who will be randomly assigned to either continue or stop swimming for 4-6 weeks. Other objective and subjective health benefits to sea swimming will also be explored in this study. Given the ubiquitous nature of this activity in the Irish general public, particularly in Galway, this study has potential from a public health perspective, and would add to the literature base pertaining to the benefits of sea swimming on cardiovascular health.
Detailed description
Consenting participants will be randomly assigned, 1:1, to either continuation of sea swimming or discontinuation of sea swimming for 4-6 weeks, stratified by the type of swimmer (those who purely immerse in the water for a brief period of time versus those who actually swim [i.e., exercise] in the water) and use of blood pressure medication at the time of study commencement (yes or no), using a block size of four to maintain balance between intervention arms. In line with previous studies that assessed the impact of swimming intervention on BP, participants randomized to the swimming arm should pursue sea swimming 2 or more days/week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No sea swimming | Experimental | Other: No cold-water sea swimmingStop sea swimming for 4-6 weeks |
| Sea swimming | Active comparator | Other: Cold-water sea swimmingContinue sea swimming for 4-6 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- habitual swimmers (i.e., sea swimming at least 2 times/week for the past year)
- 18 years of age or older
- able to provide informed consent
Key exclusion criteria (5 listed)
- underlying cardiac (e.g., self-reported heart failure) or pulmonary diseases (e.g., self-reported chronic obstructive pulmonary disease)
- recent orthopedic procedures (e.g., joint replacement therapy)
- severe disabling comorbidity
- recent arm (both arms) or chest wall injury
- pregnant or breast feeding
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 |
|---|---|---|
| Cold-water sea swimmingContinue sea swimming for 4-6 weeks | Other | Sea swimming |
| No cold-water sea swimmingDiscontinue sea swimming for 4-6 weeks | Other | No sea swimming |
Primary outcome
Change in mean systolic blood pressure
Time frame: Measured at baseline and again at 6 weeks
Systolic blood pressure recorded using a 24-hour ambulatory blood pressure monitor
5 secondary outcomes
Change in Pulse Wave Velocity
Time frame: Measured at baseline and 6 weeks
Change in Augmentation index
Time frame: Measured at baseline and 6 weeks
Change in Heart rate variability
Time frame: Measured at baseline and 6 weeks
Change in Health-related quality of life
Time frame: Administered at baseline and 6 weeks
Change in mean diastolic blood pressure
Time frame: Measured at baseline and again at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
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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.
John William McEvoy, MBBCh MHS principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold-water sea swimming and No cold-water sea swimming in people with Cardiovascular Diseases and Hypertension, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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 3 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: paused, as of the sponsor's last update on 30 Jun 2020. 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 Ireland. 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?
Results are not available in the source record.
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?
Change in mean systolic blood pressure (time frame: Measured at baseline and again at 6 weeks). 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 30 Jun 2020.