The Galway Sea Swimmers Study

NCT04290637 | Suspended DMC

• 1 other identifier: C.A. 2327
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in mean systolic blood pressure

  Systolic blood pressure recorded using a 24-hour ambulatory blood pressure monitor

  Measured at baseline and again at 6 weeks

Secondary Outcomes (5)

• Change in Pulse Wave Velocity

  Measured at baseline and 6 weeks

• Change in Augmentation index

  Measured at baseline and 6 weeks

• Change in Heart rate variability

  Measured at baseline and 6 weeks

• Change in Health-related quality of life

  Administered at baseline and 6 weeks

• Change in mean diastolic blood pressure

  Measured at baseline and again at 6 weeks

Other Outcomes (2)

• Change in Sleep quality

  Administered at baseline and 6 weeks

• Change in Muscular strength

  Measured at baseline and 6 weeks

Study Arms (2)

No sea swimming

EXPERIMENTAL

Stop sea swimming for 4-6 weeks

Other: No cold-water sea swimming

Sea swimming

ACTIVE COMPARATOR

Continue sea swimming for 4-6 weeks

Other: Cold-water sea swimming

Interventions

Cold-water sea swimming OTHER

Continue sea swimming for 4-6 weeks

Sea swimming

No cold-water sea swimming OTHER

Discontinue sea swimming for 4-6 weeks

No sea swimming

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• habitual swimmers (i.e., sea swimming at least 2 times/week for the past year)
• years of age or older
• able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (1)

Croi Heart and Stroke Centre

Galway, H91 FF68, Ireland

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Heart Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Behavior

Study Officials

• John William McEvoy, MBBCh MHS

  National University of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Preventive Cardiology

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 2, 2020
• Study Start: October 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)