The Galway Sea Swimmers Study

NCT ID: NCT04290637

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-10-31

Brief Summary

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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

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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

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Cardiovascular Diseases Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No sea swimming

Stop sea swimming for 4-6 weeks

Group Type EXPERIMENTAL

No cold-water sea swimming

Intervention Type OTHER

Discontinue sea swimming for 4-6 weeks

Sea swimming

Continue sea swimming for 4-6 weeks

Group Type ACTIVE_COMPARATOR

Cold-water sea swimming

Intervention Type OTHER

Continue sea swimming for 4-6 weeks

Interventions

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Cold-water sea swimming

Continue sea swimming for 4-6 weeks

Intervention Type OTHER

No cold-water sea swimming

Discontinue sea swimming for 4-6 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Ireland, Galway, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Prof. John William McEvoy

Professor, Preventive Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John William McEvoy, MBBCh MHS

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway

Locations

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Croi Heart and Stroke Centre

Galway, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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C.A. 2327

Identifier Type: -

Identifier Source: org_study_id

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