The Galway Sea Swimmers Study (GS3)
Primary Purpose
Cardiovascular Diseases, Hypertension
Status
Suspended
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Cold-water sea swimming
No cold-water sea swimming
Sponsored by

About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Croi Heart and Stroke Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No sea swimming
Sea swimming
Arm Description
Stop sea swimming for 4-6 weeks
Continue sea swimming for 4-6 weeks
Outcomes
Primary Outcome Measures
Change in mean systolic blood pressure
Systolic blood pressure recorded using a 24-hour ambulatory blood pressure monitor
Secondary Outcome Measures
Change in Pulse Wave Velocity
Pulse wave velocity measured using Complior Device
Change in Augmentation index
Augmentation index measured using Complior device
Change in Heart rate variability
Measured using 24-hour ambulatory blood pressure monitor
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)
Change in mean diastolic blood pressure
Diastolic blood pressure recorded using a 24-hour ambulatory blood pressure monitor
Full Information
NCT ID
NCT04290637
First Posted
February 24, 2020
Last Updated
June 26, 2020
Sponsor
National University of Ireland, Galway, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT04290637
Brief Title
The Galway Sea Swimmers Study
Acronym
GS3
Official Title
The Galway Sea Swimmers Study: A Randomized Study of the Effect of Cold-Water Sea Swimming on Cardiovascular Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Suspended
Why Stopped
Unable to recruit during COVID-19 crisis
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Hypertension
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No sea swimming
Arm Type
Experimental
Arm Description
Stop sea swimming for 4-6 weeks
Arm Title
Sea swimming
Arm Type
Active Comparator
Arm Description
Continue sea swimming for 4-6 weeks
Intervention Type
Other
Intervention Name(s)
Cold-water sea swimming
Intervention Description
Continue sea swimming for 4-6 weeks
Intervention Type
Other
Intervention Name(s)
No cold-water sea swimming
Intervention Description
Discontinue sea swimming for 4-6 weeks
Primary Outcome Measure Information:
Title
Change in mean systolic blood pressure
Description
Systolic blood pressure recorded using a 24-hour ambulatory blood pressure monitor
Time Frame
Measured at baseline and again at 6 weeks
Secondary Outcome Measure Information:
Title
Change in Pulse Wave Velocity
Description
Pulse wave velocity measured using Complior Device
Time Frame
Measured at baseline and 6 weeks
Title
Change in Augmentation index
Description
Augmentation index measured using Complior device
Time Frame
Measured at baseline and 6 weeks
Title
Change in Heart rate variability
Description
Measured using 24-hour ambulatory blood pressure monitor
Time Frame
Measured at baseline and 6 weeks
Title
Change in Health-related quality of life
Description
Measure using EQ-VAS (visual analog scale) instrument. Values between 0 (worst imaginable health) and 100 (best imaginable health)
Time Frame
Administered at baseline and 6 weeks
Title
Change in mean diastolic blood pressure
Description
Diastolic blood pressure recorded using a 24-hour ambulatory blood pressure monitor
Time Frame
Measured at baseline and again at 6 weeks
Other Pre-specified Outcome Measures:
Title
Change in Sleep quality
Description
Measured using Pittsburgh Sleep Quality Index. Values between 0 and 21, higher score indicates worse sleep quality
Time Frame
Administered at baseline and 6 weeks
Title
Change in Muscular strength
Description
Measured using Hand grip dynamometer
Time Frame
Measured at baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John William McEvoy, MBBCh MHS
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croi Heart and Stroke Centre
City
Galway
ZIP/Postal Code
H91 FF68
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Galway Sea Swimmers Study
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