NCT04308057

Brief Summary

Cardiovascular ageing is implicated in the development of cardiovascular disease (CVD). Aquatic exercise is being considered as a co-adjuvant form of rehabilitation, but there is limited evidence for its cardiovascular risk-reduction properties for older people. Our study aims to address this by exploring the cardiovascular effects of long-term aquatic exercise in older adults in comparison to those who are either inactive or engaged in land-based/mixed training by measurement of micro- and macro-circulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

February 24, 2020

Last Update Submit

September 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Nitric oxide-mediated, macro (arterial)- circulatory function.

    We will use FMD as a measure of endothelium-dependent, nitric oxide (NO)-mediated, macro (arterial)- circulatory function. Baseline scanning to assess resting vessel diameter will be recorded over 3 minutes, following a 10-minute resting period. A rapid inflation-deflation pneumatic cuff placed immediately distal to the elbow joint will be used to as an FMD stimulus.

    Baseline.

  • Nitric oxide-mediated, macro (arterial)- circulatory function.

    We will use FMD as a measure of endothelium-dependent, nitric oxide (NO)-mediated, macro (arterial)- circulatory function. Baseline scanning to assess resting vessel diameter will be recorded over 3 minutes, following a 10-minute resting period. A rapid inflation-deflation pneumatic cuff placed immediately distal to the elbow joint will be used to as an FMD stimulus.

    8 weeks.

Secondary Outcomes (15)

  • Microcirculatory function

    Baseline.

  • Microcirculatory function

    8 weeks.

  • Anthropometry - 1

    Baseline.

  • Anthropometry - 2

    Baseline.

  • Anthropometry - 1

    8 weeks.

  • +10 more secondary outcomes

Study Arms (4)

Aquatic Exercise

General inclusion criteria included being over 55 years of age and normotensive (e.g., \<140/90 mm Hg). Specifically for this group, we include participants engaging in swimming or other aquatic, primarily aerobic-based, training regimes for more than 2 times a week, for more than 6 months, at the time of the assessments.

Land-based exercise

General inclusion criteria included being over 55 years of age and normotensive (e.g., \<140/90 mm Hg). Specifically for this group, we include participants engaging in land-based, primarily aerobic training regimes (e.g. aerobic exercise) for more than 2 times a week, for a period longer than 6 months, at the time of the assessments.

Mixed exercise

General inclusion criteria included being over 55 years of age and normotensive (e.g., \<140/90 mm Hg). Specifically for this group, we include participants engaging in both land-based and aquatic, primarily aerobic, exercise regimes on an equal basis, for more than 6 months.

Sedentary.

General inclusion criteria included being over 55 years of age and normotensive (e.g., \<140/90 mm Hg). Specifically for this group, we include participants who are sedentary (e.g., defined as undertaking less than 60 min of structured/planned physical activity per week), for a period longer than 6 months.

Procedure: Aquatic exercise

Interventions

Participants belonging to Group D (sedentary group) will be randomised 1-to-1 between remaining sedentary (n=20) and following a self-managed, 8-week, aquatic-based exercise programme (n=20). The latter group will be offered an 8-week access to pool facilities. For Group D participants, all baseline assessments will be repeated at 8 weeks.

Sedentary.

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Group A (n=20) consists of participants engaging in swimming or other aquatic, primarily aerobic-based, training regimes for more than 2 times a week, for more than 6 months, at the time of the assessments. Similarly, Group B (n=20) consists of participants engaging in land-based, primarily aerobic training regimes (e.g. aerobic exercise) for more than 2 times a week, for a period longer than 6 months, at the time of the assessments. Group C (n=20) consists of participants who were cengaging in both land-based and aquatic, primarily aerobic, exercise regimes on an equal basis, for more than 6 months, while Group D (n=40) consists of people who were sedentary (e.g., defined as undertaking less than 60 min of structured/planned physical activity per week), for a period longer than 6 months.

You may qualify if:

  • being over 55 years of age and normotensive (e.g., \<140/90 mm Hg).

You may not qualify if:

  • any overt chronic disease which would affect microvascular functioning,
  • anaemia (irrespective of whether an iron supplementation course is followed or not)
  • a recent (3 months' ago) major surgery
  • None of the participants were undertaking high intensity interval training of any form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Hallam University

Sheffield, Yorkshire, S10 2BP, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Aquatic Therapy

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Markos Klonizakis, D.Phil.

    Sheffield Hallam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

March 13, 2020

Study Start

December 1, 2019

Primary Completion

February 19, 2021

Study Completion

August 30, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Ethical approval prevents data sharing.

Locations