Cardiovascular Diseases Clinical Trial
— ACELAOfficial title:
Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults
NCT number | NCT04308057 |
Other study ID # | ER5320861 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | August 30, 2022 |
Verified date | September 2022 |
Source | Sheffield Hallam University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 30, 2022 |
Est. primary completion date | February 19, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sheffield Hallam University | Sheffield | Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Hallam University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | 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. | Baseline. | |
Secondary | 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. | 8 weeks. | |
Secondary | Anthropometry - 1 | Stature, waist and hip circumferences will be measured (all in cms). | Baseline. | |
Secondary | Anthropometry - 2 | Body mass will be measured. | Baseline. | |
Secondary | Anthropometry - 1 | Stature, waist and hip circumferences will be measured (all in cms). | 8 weeks. | |
Secondary | Anthropometry - 2 | Body mass will be measured. | 8 weeks. | |
Secondary | EQ-5D-5L | The EQ5D-5L questionnaire will be completed, to support assessment of quality of life. | Baseline. | |
Secondary | EQ-5D-5L | The EQ5D-5L questionnaire will be completed, to support assessment of quality of life. | 8 weeks. | |
Secondary | SF-IPAQ | The SF-IPAQ questionnaire will be completed, to assess physical activity levels. | Baseline. | |
Secondary | SF-IPAQ | The SF-IPAQ questionnaire will be completed, to assess physical activity levels. | 8 weeks. | |
Secondary | Q-Risk | The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk | Baseline. | |
Secondary | Q-Risk | The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk | 8 weeks. | |
Secondary | Feasibility outcome - 1 | Recruitment rate (% of those expressing an interest, being actually recruited). | Baseline | |
Secondary | Feasibility outcome - 2 | Adherence rate (% of those recruited completing at least 75% of the prescribed number of exercise sessions). | 8 weeks | |
Secondary | Feasibility outcome - 3 | Retention rate (% of those recruited completing the post-intervention assessments). | 8 weeks |
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