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

Sponsor
Sheffield Hallam University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04308057
Collaborator
(none)
80
1
35
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Aquatic exercise

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Feb 19, 2021
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Nitric oxide-mediated, macro (arterial)- circulatory function. [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. [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 Outcome Measures

  1. Microcirculatory function [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 [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 [Baseline.]

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

  4. Anthropometry - 2 [Baseline.]

    Body mass will be measured.

  5. Anthropometry - 1 [8 weeks.]

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

  6. Anthropometry - 2 [8 weeks.]

    Body mass will be measured.

  7. EQ-5D-5L [Baseline.]

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

  8. EQ-5D-5L [8 weeks.]

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

  9. SF-IPAQ [Baseline.]

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

  10. SF-IPAQ [8 weeks.]

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

  11. Q-Risk [Baseline.]

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

  12. Q-Risk [8 weeks.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sheffield Hallam University Sheffield Yorkshire United Kingdom S10 2BP

Sponsors and Collaborators

  • Sheffield Hallam University

Investigators

  • Principal Investigator: Markos Klonizakis, D.Phil., Sheffield Hallam University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheffield Hallam University
ClinicalTrials.gov Identifier:
NCT04308057
Other Study ID Numbers:
  • ER5320861
First Posted:
Mar 13, 2020
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022