Healthy Aging Clinical Trial
Official title:
The Effects of Post Aerobic Exercise Hot Water Immersion on Physiological and Perceptual Responses in Physically Inactive Middle-aged Adults
NCT number | NCT05035004 |
Other study ID # | P97102 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 15, 2021 |
Est. completion date | March 16, 2022 |
Verified date | March 2022 |
Source | Coventry University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate the effects of post moderate intensity aerobic exercise hot water immersion on physiological and perceptual responses in physically inactive middle-aged adults when compared to moderate intensity aerobic exercise and hot water immersion alone.
Status | Completed |
Enrollment | 16 |
Est. completion date | March 16, 2022 |
Est. primary completion date | March 16, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility | Inclusion Criteria: - Males and post menopausal females - Aged between 40 - 60 years - BMI of 18.5 - 34.9 kg/m2 - Over the last 6 months has participated in less than 150 mins of moderate intensity physical activity or 75 mins of vigorous activity or a combination of both, but takes part in some form of physical activity within their weekly routine. - Maximal oxygen uptake categorised as 'fair' for a given age group. Exclusion Criteria: - Previous myocardial infarction or cerebrovascular event - Any signs or symptoms of cardiovascular issues - High blood pressure: SBP >180 mmHg and / or DBP >100 mmHg - Orthostatic hypotension: Drop of SBP > 20mmHg and / or DBP >10 mmHg upon standing. - Changed blood pressure medication in the 6-month period prior to the study - Plan to change any form of relevant medication during study period - Suffers from diabetes - Suffers from severe asthma - Currently have any infections or symptoms of an infection (e.g. COVID-19 etc) - Suffers from a neurodegenerative disease - Cannot understand and/or fully cooperate with the study protocol - Exercise-limiting comorbidity (e.g. angina, chronic lung disease, arthritis etc) - Severe peripheral neuropathy (cannot sense temperature) - Current smoker or have stopped in the last 3 months - Any skin conditions including ulcerations - Exposed to high temperatures in the last 4-weeks (e.g. holiday, spa, sun beds etc) - Use of antioxidant supplements in the last 6-weeks |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Coventry University | Coventry | West Midlands |
Lead Sponsor | Collaborator |
---|---|
Coventry University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in rectal core temperature (°C) | Measured using a rectal probe attached to a squirrel data logger | Measurements taken at 10 minute intervals up to 100 minutes | |
Other | Change in forehead skin temperature (°C) | Measured using skin thermistors attached to a squirrel data logger | Measurements taken at 10 minute intervals up to 100 minutes | |
Other | Change in heart rate (bpm) | Measured using a heart rate monitor | Measurements taken at 10 minute intervals up to 100 minutes | |
Other | Change in plasma volume (%) | Measured by a capillary blood sample then calculating plasma volume via the hemoglobin and hematocrit | Measurements taken pre and immediately post intervention | |
Primary | Change in circulating plasma nitrite (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Primary | Change in brachial artery total shear rate (S-1) | Terason ultrasound recording of the brachial and superficial femoral artery | Measured at 0, 30, 70 and 100 minutes | |
Primary | Change in brachial artery antegrade shear rate (S-1) | Terason ultrasound recording of the brachial and superficial femoral artery. | Measured at 0, 30, 70 and 100 minutes | |
Primary | Change in brachial artery retrograde shear rate (S-1) | Terason ultrasound recording of the brachial and superficial femoral artery | Measured at 0, 30, 70 and 100 minutes | |
Primary | Change in brachial artery diameter (mm) | Terason ultrasound recording of the brachial and superficial femoral artery | Measured at 0, 30, 70 and 100 minutes | |
Primary | Change in brachial artery blood flow (ml/min) | Terason ultrasound recording of the brachial and superficial femoral artery. | Measured at 0, 30, 70 and 100 minutes | |
Primary | Change in brachial artery compliance (µm/mmHg) | Terason ultrasound recording of the brachial artery. Brachial artery compliance will be calculated by using the change in blood volume and blood pressure | Measured at 0, 30, 70 and 100 minutes | |
Primary | Change in systolic blood pressure (mmHg) | Measured using an automated blood pressure cuff | Measurements taken at 10 minute intervals up to 100 minutes | |
Primary | Change in diastolic blood pressure (mmHg) | Measured using an automated blood pressure cuff | Measurements taken at 10 minute intervals up to 100 minutes | |
Primary | Change in mean arterial pressure (mmHg) | Measured using an automated blood pressure cuff. Mean arterial pressure will be calculated by using systolic and diastolic blood pressure | Measurements taken at 10 minute intervals up to 100 minutes | |
Primary | Change in pulse pressure (mmHg) | Measured using an automated blood pressure cuff. Pulse pressure will be calculated using systolic and diastolic blood pressure | Measurements taken at 10 minute intervals up to 100 minutes | |
Secondary | Change in circulating serum Interleukin-6 (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Change in circulating serum Interleukin-10 (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Change in circulating serum Interleukin-8 (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Change in circulating serum Interleukin-1Ra (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Change in circulating serum Vascular endothelial growth factor (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Change in circulating serum Endothelin-1 (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Circulating serum Monocyte chemoattractant protein-1 (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Change in circulating serum Matrix metallopeptidase-2 (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Change in circulating serum Matrix metallopeptidase-9 (pg/ml) | Venous blood sample | Measured at 0, 30, 70 and 100 minutes | |
Secondary | Energy expenditure (kcal/h-1) | Measured initially by breath by breath analysis through the use of a Ultima and calculated via indirect calorimetry | Gas measurements taken continually up to 70 minutes. Energy expenditure calculated from the 30 minutes of exercise, hot water immersion and/or rest periods. | |
Secondary | Change in thermal comfort | Thermal comfort Likert scale from a positive score of +5 very comfortable (maximum) to a negative score of -5 very uncomfortable (minimum) | Measured at 10 minute intervals up to 100 minutes | |
Secondary | Change in thermal sensation | Thermal sensation Likert scale from +5 (maximum) hot to -5 cold (minimum) | Measured at 10 minute intervals up to 100 minutes | |
Secondary | Change in basic affect | Basic affect Likert scale from a positive score of +5 very good (maximum) to a negative score of -5 very bad (minimum) | Measured at 10 minute intervals up to 100 minutes | |
Secondary | Change in physical activity enjoyment scale | Feelings about exercise and / or passive heating on a Likert scale from a positive score of 1 (maximum) to a negative score of 7 (minimum) | Measured ~12 minutes post intervention |
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