- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04308057
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
Conditions
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).
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8 weeks.
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Anthropometry - 2
Time Frame: Baseline.
|
Body mass will be measured.
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Baseline.
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Anthropometry - 2
Time Frame: 8 weeks.
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Body mass will be measured.
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8 weeks.
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SF-IPAQ
Time Frame: Baseline.
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The SF-IPAQ questionnaire will be completed, to assess physical activity levels.
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Baseline.
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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.
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The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
|
Baseline.
|
EQ-5D-5L
Time Frame: 8 weeks.
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The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
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8 weeks.
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SF-IPAQ
Time Frame: 8 weeks.
|
The SF-IPAQ questionnaire will be completed, to assess physical activity levels.
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8 weeks.
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Q-Risk
Time Frame: Baseline.
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The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk
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Baseline.
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Q-Risk
Time Frame: 8 weeks.
|
The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk
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8 weeks.
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Feasibility outcome - 1
Time Frame: Baseline
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Recruitment rate (% of those expressing an interest, being actually recruited).
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Baseline
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Feasibility outcome - 2
Time Frame: 8 weeks
|
Adherence rate (% of those recruited completing at least 75% of the prescribed number of exercise sessions).
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8 weeks
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Feasibility outcome - 3
Time Frame: 8 weeks
|
Retention rate (% of those recruited completing the post-intervention assessments).
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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