Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults (ACELA)

September 12, 2022 updated by: Sheffield Hallam University
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yorkshire
      • Sheffield, Yorkshire, United Kingdom, S10 2BP
        • Sheffield Hallam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nitric oxide-mediated, macro (arterial)- circulatory function.
Time Frame: Baseline.
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.
Time Frame: 8 weeks.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometry - 1
Time Frame: Baseline.
Stature, waist and hip circumferences will be measured (all in cms).
Baseline.
Anthropometry - 1
Time Frame: 8 weeks.
Stature, waist and hip circumferences will be measured (all in cms).
8 weeks.
Anthropometry - 2
Time Frame: Baseline.
Body mass will be measured.
Baseline.
Anthropometry - 2
Time Frame: 8 weeks.
Body mass will be measured.
8 weeks.
SF-IPAQ
Time Frame: Baseline.
The SF-IPAQ questionnaire will be completed, to assess physical activity levels.
Baseline.
Microcirculatory function
Time Frame: Baseline.
Skin blood flow will be measured as cutaneous red blood cell flux using a Laser Doppler Flowmeter (LDF). Local thermal hyperaemia will be induced using a heating disc surrounding the probe. The probe will be attached to the skin using a double-sided adhesion sticker. Participants will be rested in a supine position in a temperature-controlled room with a constant ambient temperature of 24° C for 35 minutes. Heart rate and diastolic and systolic blood pressure was recorded from the left arm at 5-minute intervals throughout the protocol (Dinamap Dash 2500, GE Healthcare, USA). Baseline skin blood flow data will be recorded for 5 minutes with the local heating disc temperature set at 30° C. Following this, rapid local heating will be initiated to obtain maximal vasodilation and the temperature will be increased by 1° C every 10 seconds until 42° C was reached. This will then be maintained for 30 minutes following, which the test will be completed.
Baseline.
Microcirculatory function
Time Frame: 8 weeks.
Skin blood flow will be measured as cutaneous red blood cell flux using a Laser Doppler Flowmeter (LDF). Local thermal hyperaemia will be induced using a heating disc surrounding the probe. The probe will be attached to the skin using a double-sided adhesion sticker. Participants will be rested in a supine position in a temperature-controlled room with a constant ambient temperature of 24° C for 35 minutes. Heart rate and diastolic and systolic blood pressure was recorded from the left arm at 5-minute intervals throughout the protocol (Dinamap Dash 2500, GE Healthcare, USA). Baseline skin blood flow data will be recorded for 5 minutes with the local heating disc temperature set at 30° C. Following this, rapid local heating will be initiated to obtain maximal vasodilation and the temperature will be increased by 1° C every 10 seconds until 42° C was reached. This will then be maintained for 30 minutes following, which the test will be completed.
8 weeks.
EQ-5D-5L
Time Frame: Baseline.
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
Baseline.
EQ-5D-5L
Time Frame: 8 weeks.
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
8 weeks.
SF-IPAQ
Time Frame: 8 weeks.
The SF-IPAQ questionnaire will be completed, to assess physical activity levels.
8 weeks.
Q-Risk
Time Frame: Baseline.
The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk
Baseline.
Q-Risk
Time Frame: 8 weeks.
The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk
8 weeks.
Feasibility outcome - 1
Time Frame: Baseline
Recruitment rate (% of those expressing an interest, being actually recruited).
Baseline
Feasibility outcome - 2
Time Frame: 8 weeks
Adherence rate (% of those recruited completing at least 75% of the prescribed number of exercise sessions).
8 weeks
Feasibility outcome - 3
Time Frame: 8 weeks
Retention rate (% of those recruited completing the post-intervention assessments).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Markos Klonizakis, D.Phil., Sheffield Hallam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

February 19, 2021

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ER5320861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethical approval prevents data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Aquatic exercise

3
Subscribe