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Completed

NCT Number: NCT04308057

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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Hallam University

Sheffield, Yorkshire, S10 2BP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aquatic exercise

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Anthropometry - 1

    Time frame: Baseline.

    Stature, waist and hip circumferences will be measured (all in cms).

  4. Anthropometry - 2

    Time frame: Baseline.

    Body mass will be measured.

  5. Anthropometry - 1

    Time frame: 8 weeks.

    Stature, waist and hip circumferences will be measured (all in cms).

  6. Anthropometry - 2

    Time frame: 8 weeks.

    Body mass will be measured.

  7. EQ-5D-5L

    Time frame: Baseline.

    The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.

  8. EQ-5D-5L

    Time frame: 8 weeks.

    The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.

  9. SF-IPAQ

    Time frame: Baseline.

    The SF-IPAQ questionnaire will be completed, to assess physical activity levels.

  10. SF-IPAQ

    Time frame: 8 weeks.

    The SF-IPAQ questionnaire will be completed, to assess physical activity levels.

  11. Q-Risk

    Time frame: Baseline.

    The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk

  12. Q-Risk

    Time frame: 8 weeks.

    The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk

  13. Feasibility outcome - 1

    Time frame: Baseline

    Recruitment rate (% of those expressing an interest, being actually recruited).

  14. Feasibility outcome - 2

    Time frame: 8 weeks

    Adherence rate (% of those recruited completing at least 75% of the prescribed number of exercise sessions).

  15. Feasibility outcome - 3

    Time frame: 8 weeks

    Retention rate (% of those recruited completing the post-intervention assessments).

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Registry information

Acronym: ACELA

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 13, 2020
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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