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

Cardiovascular Diseases Clinical Trial

— ACELA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308057
• Other study ID #: ER5320861
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2022
• Source: Sheffield Hallam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Procedure:
• Aquatic exercise
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.

Locations

Country	Name	City	State
United Kingdom	Sheffield Hallam University	Sheffield	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome

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