Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
Study NCT ID:
NCT04308057
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2020-02-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088543', 'term': 'Aquatic Therapy'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nitric oxide-mediated, macro (arterial)- circulatory function.', 'timeFrame': 'Baseline.', 'description': '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.'}, {'measure': 'Nitric oxide-mediated, macro (arterial)- circulatory function.', 'timeFrame': '8 weeks.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Microcirculatory function', 'timeFrame': 'Baseline.', 'description': '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.'}, {'measure': 'Microcirculatory function', 'timeFrame': '8 weeks.', 'description': '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.'}, {'measure': 'Anthropometry - 1', 'timeFrame': 'Baseline.', 'description': 'Stature, waist and hip circumferences will be measured (all in cms).'}, {'measure': 'Anthropometry - 2', 'timeFrame': 'Baseline.', 'description': 'Body mass will be measured.'}, {'measure': 'Anthropometry - 1', 'timeFrame': '8 weeks.', 'description': 'Stature, waist and hip circumferences will be measured (all in cms).'}, {'measure': 'Anthropometry - 2', 'timeFrame': '8 weeks.', 'description': 'Body mass will be measured.'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'Baseline.', 'description': 'The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.'}, {'measure': 'EQ-5D-5L', 'timeFrame': '8 weeks.', 'description': 'The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.'}, {'measure': 'SF-IPAQ', 'timeFrame': 'Baseline.', 'description': 'The SF-IPAQ questionnaire will be completed, to assess physical activity levels.'}, {'measure': 'SF-IPAQ', 'timeFrame': '8 weeks.', 'description': 'The SF-IPAQ questionnaire will be completed, to assess physical activity levels.'}, {'measure': 'Q-Risk', 'timeFrame': 'Baseline.', 'description': 'The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk'}, {'measure': 'Q-Risk', 'timeFrame': '8 weeks.', 'description': 'The online Q-Risk questionnaire will be competed, which assesses the risk of cardiovascular disease risk'}, {'measure': 'Feasibility outcome - 1', 'timeFrame': 'Baseline', 'description': 'Recruitment rate (% of those expressing an interest, being actually recruited).'}, {'measure': 'Feasibility outcome - 2', 'timeFrame': '8 weeks', 'description': 'Adherence rate (% of those recruited completing at least 75% of the prescribed number of exercise sessions).'}, {'measure': 'Feasibility outcome - 3', 'timeFrame': '8 weeks', 'description': 'Retention rate (% of those recruited completing the post-intervention assessments).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* being over 55 years of age and normotensive (e.g., \\<140/90 mm Hg).\n\nExclusion Criteria:\n\n* any overt chronic disease which would affect microvascular functioning,\n* anaemia (irrespective of whether an iron supplementation course is followed or not)\n* a recent (3 months' ago) major surgery\n* None of the participants were undertaking high intensity interval training of any form."}, 'identificationModule': {'nctId': 'NCT04308057', 'acronym': 'ACELA', 'briefTitle': 'Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Hallam University'}, 'officialTitle': 'Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults', 'orgStudyIdInfo': {'id': 'ER5320861'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aquatic Exercise', 'description': '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.'}, {'label': 'Land-based exercise', 'description': '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.'}, {'label': 'Mixed exercise', 'description': '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.'}, {'label': 'Sedentary.', 'description': '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.', 'interventionNames': ['Procedure: Aquatic exercise']}], 'interventions': [{'name': 'Aquatic exercise', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Sedentary.']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2BP', 'city': 'Sheffield', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Sheffield Hallam University', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Markos Klonizakis, D.Phil.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Hallam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Ethical approval prevents data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Hallam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}