Cardiovascular DiseasesACELANCT04308057
Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults
An observational study of Cardiovascular Diseases, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Aquatic exercise
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2019to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- being over 55 years of age and normotensive (e.g., <140/90 mm Hg).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University
Sheffield, Yorkshire, S10 2BP
About this study
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Aquatic exercise
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic exerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Aquatic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks.
Secondary outcomes (15)
Microcirculatory function
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.
Measured: Baseline.
Microcirculatory function
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.
Measured: 8 weeks.
Anthropometry - 1
Stature, waist and hip circumferences will be measured (all in cms).
Measured: Baseline.
Anthropometry - 2
Body mass will be measured.
Measured: Baseline.
Anthropometry - 1
Stature, waist and hip circumferences will be measured (all in cms).
Measured: 8 weeks.
Anthropometry - 2
Body mass will be measured.
Measured: 8 weeks.
EQ-5D-5L
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
Measured: Baseline.
EQ-5D-5L
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
Measured: 8 weeks.
SF-IPAQ
The SF-IPAQ questionnaire will be completed, to assess physical activity levels.
Measured: Baseline.
SF-IPAQ
The SF-IPAQ questionnaire will be completed, to assess physical activity levels.
Measured: 8 weeks.
Q-Risk
The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk
Measured: Baseline.
Q-Risk
The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk
Measured: 8 weeks.
Feasibility outcome - 1
Recruitment rate (% of those expressing an interest, being actually recruited).
Measured: Baseline
Feasibility outcome - 2
Adherence rate (% of those recruited completing at least 75% of the prescribed number of exercise sessions).
Measured: 8 weeks
Feasibility outcome - 3
Retention rate (% of those recruited completing the post-intervention assessments).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Dec 2019
- Primary completion19 Feb 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markos Klonizakis, D.Phil., Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308057
- Sponsor's protocol ID
- ER5320861
- Acronym
- ACELA
- Status last verified
- Sep 2022
- First submitted
- 24 Feb 2020
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical approval prevents data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults
- ClinicalTrials.gov ID
- NCT04308057
- Acronym / sponsor ID
- ACELA / ER5320861
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. | – | Procedure: Aquatic exerciseGeneral 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- being over 55 years of age and normotensive (e.g., <140/90 mm Hg).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic exerciseParticipants 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. | Procedure or surgery | Sedentary. |
Primary outcome
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.
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.
15 secondary outcomes
Microcirculatory function
Time frame: Baseline.
Microcirculatory function
Time frame: 8 weeks.
Anthropometry - 1
Time frame: Baseline.
Anthropometry - 2
Time frame: Baseline.
Anthropometry - 1
Time frame: 8 weeks.
Anthropometry - 2
Time frame: 8 weeks.
EQ-5D-5L
Time frame: Baseline.
EQ-5D-5L
Time frame: 8 weeks.
SF-IPAQ
Time frame: Baseline.
SF-IPAQ
Time frame: 8 weeks.
Q-Risk
Time frame: Baseline.
Q-Risk
Time frame: 8 weeks.
Feasibility outcome - 1
Time frame: Baseline
Feasibility outcome - 2
Time frame: 8 weeks
Feasibility outcome - 3
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No. Ethical approval prevents data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markos Klonizakis, D.Phil. principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nitric oxide-mediated, macro (arterial)- circulatory function. (time frame: Baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.