Healthy AgingNCT05035004
The Effects of Post Aerobic Exercise Hot Water Immersion on Physiological and Perceptual Responses in Physically Inactive Middle-aged Adults
A study testing Post exercise hot water immersion, Exercise and Hot water immersion in people with Healthy Aging, run by Coventry University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Post exercise hot water immersion, Exercise and Hot water immersion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2021to 16 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Coventry University
Coventry, West Midlands, CV1 5FB
About this study
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.
Read the detailed description
A large number of middle aged adults do not achieve the minimum recommended amount of physical activity. This consequently increases the risk of cardiovascular disease and all-cause mortality. Although below the recommended physical activity guidelines, it is important to highlight that a considerable proportion of these individuals do take part in some form of physical activity within their weekly routines. Hence, identifying complementary therapies that can enhance the health benefits from smaller amounts of exercise are of great value for many physically inactive middle-aged adults.
An in increase in body temperature from a single session of passive heating has been shown to mimic many of the beneficial physiological responses of exercise, such as, an increase in heart rate, skin blood flow and an increase in circulating angiogenic factors. However, lab based studies often push participants to the limit of thermal tolerance which may reduce long term adherence in the real world. Therefore, this study will investigate whether the use of post exercise hot water immersion can prolong and / or intensify exercise mediated physiological responses that underpin health benefits, whilst also assessing the perceptual responses, in comparison to exercise and hot water immersion alone.
Through the use of a repeated measures design, participants will randomly take part in three conditions; 1) post exercise hot water immersion (30 minutes of moderate intensity cycling followed by 10 minutes of supine rest and 30 minutes of whole body hot water immersion at 40°C); 2) aerobic exercise (30 minutes of moderate intensity cycling followed by 10 minutes of supine rest and 30 minutes of seated rest at room temperature); 3) hot water immersion condition (30 minutes of whole body hot water immersion at 40°C followed by 10 minutes of supine rest and 30 minutes of whole body hot water immersion at 40°C). Each condition will be separated by a minimum of 1-week. Outcome measures will either be assessed at regular intervals or at 0, 30, 70 and 100 minute time points for each condition.
- Conditions
- Healthy Aging
- Being tested
- Post exercise hot water immersion, Exercise, Hot water immersion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post exercise hot water immersionDevice
Participants will complete 30 minutes of cycling on a lode bicycle ergometer (50% of VO2max), followed by a 10-minute transfer period and then 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C).
ExerciseDevice
Participants will complete 30 minutes of cycling on a lode bicycle ergometer (50% of VO2max).
Hot water immersionDevice
Participants will complete 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C), followed by a 10-minute transfer period and then an additional 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C).
| Study group | Role | What they receive |
|---|---|---|
| Post exercise hot water immersion | Experimental | Moderate intensity cycling for 30 minutes, followed by a 10-minute transfer period and then 30 minutes of whole-body hot water immersion. Receives: Device: Post exercise hot water immersion |
| Exercise | Active comparator | Moderate intensity cycling for 30 minutes. Receives: Device: Exercise |
| Hot water immersion | Active comparator | Whole-body hot water immersion for 30 minutes, followed by a 10-minute transfer period and then an additional 30 minutes of whole-body hot water immersion. Receives: Device: Hot water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circulating plasma nitrite (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Change in brachial artery total shear rate (S-1)
Terason ultrasound recording of the brachial and superficial femoral artery
Measured: Measured at 0, 30, 70 and 100 minutes
Change in brachial artery antegrade shear rate (S-1)
Terason ultrasound recording of the brachial and superficial femoral artery.
Measured: Measured at 0, 30, 70 and 100 minutes
Change in brachial artery retrograde shear rate (S-1)
Terason ultrasound recording of the brachial and superficial femoral artery
Measured: Measured at 0, 30, 70 and 100 minutes
Change in brachial artery diameter (mm)
Terason ultrasound recording of the brachial and superficial femoral artery
Measured: Measured at 0, 30, 70 and 100 minutes
Change in brachial artery blood flow (ml/min)
Terason ultrasound recording of the brachial and superficial femoral artery.
Measured: Measured at 0, 30, 70 and 100 minutes
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: Measured at 0, 30, 70 and 100 minutes
Change in systolic blood pressure (mmHg)
Measured using an automated blood pressure cuff
Measured: Measurements taken at 10 minute intervals up to 100 minutes
Change in diastolic blood pressure (mmHg)
Measured using an automated blood pressure cuff
Measured: Measurements taken at 10 minute intervals up to 100 minutes
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
Measured: Measurements taken at 10 minute intervals up to 100 minutes
Change in pulse pressure (mmHg)
Measured using an automated blood pressure cuff. Pulse pressure will be calculated using systolic and diastolic blood pressure
Measured: Measurements taken at 10 minute intervals up to 100 minutes
Secondary outcomes (14)
Change in circulating serum Interleukin-6 (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Interleukin-10 (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Interleukin-8 (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Interleukin-1Ra (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Vascular endothelial growth factor (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Endothelin-1 (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Circulating serum Monocyte chemoattractant protein-1 (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Matrix metallopeptidase-2 (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Matrix metallopeptidase-9 (pg/ml)
Venous blood sample
Measured: Measured at 0, 30, 70 and 100 minutes
Energy expenditure (kcal/h-1)
Measured initially by breath by breath analysis through the use of a Ultima and calculated via indirect calorimetry
Measured: Gas measurements taken continually up to 70 minutes. Energy expenditure calculated from the 30 minutes of exercise, hot water immersion and/or rest periods.
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: Measured at 10 minute intervals up to 100 minutes
Change in thermal sensation
Thermal sensation Likert scale from +5 (maximum) hot to -5 cold (minimum)
Measured: Measured at 10 minute intervals up to 100 minutes
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: Measured at 10 minute intervals up to 100 minutes
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: Measured ~12 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start15 Nov 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coventry University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Steward, Coventry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035004
- Sponsor's protocol ID
- P97102
- Status last verified
- Mar 2022
- First submitted
- 6 Aug 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Post Aerobic Exercise Hot Water Immersion on Physiological and Perceptual Responses in Physically Inactive Middle-aged Adults
- ClinicalTrials.gov ID
- NCT05035004
- Acronym / sponsor ID
- P97102
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Coventry UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A large number of middle aged adults do not achieve the minimum recommended amount of physical activity. This consequently increases the risk of cardiovascular disease and all-cause mortality. Although below the recommended physical activity guidelines, it is important to highlight that a considerable proportion of these individuals do take part in some form of physical activity within their weekly routines. Hence, identifying complementary therapies that can enhance the health benefits from smaller amounts of exercise are of great value for many physically inactive middle-aged adults.
An in increase in body temperature from a single session of passive heating has been shown to mimic many of the beneficial physiological responses of exercise, such as, an increase in heart rate, skin blood flow and an increase in circulating angiogenic factors. However, lab based studies often push participants to the limit of thermal tolerance which may reduce long term adherence in the real world. Therefore, this study will investigate whether the use of post exercise hot water immersion can prolong and / or intensify exercise mediated physiological responses that underpin health benefits, whilst also assessing the perceptual responses, in comparison to exercise and hot water immersion alone.
Through the use of a repeated measures design, participants will randomly take part in three conditions; 1) post exercise hot water immersion (30 minutes of moderate intensity cycling followed by 10 minutes of supine rest and 30 minutes of whole body hot water immersion at 40°C); 2) aerobic exercise (30 minutes of moderate intensity cycling followed by 10 minutes of supine rest and 30 minutes of seated rest at room temperature); 3) hot water immersion condition (30 minutes of whole body hot water immersion at 40°C followed by 10 minutes of supine rest and 30 minutes of whole body hot water immersion at 40°C). Each condition will be separated by a minimum of 1-week. Outcome measures will either be assessed at regular intervals or at 0, 30, 70 and 100 minute time points for each condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post exercise hot water immersion | Experimental | Device: Post exercise hot water immersionModerate intensity cycling for 30 minutes, followed by a 10-minute transfer period and then 30 minutes of whole-body hot water immersion. |
| Exercise | Active comparator | Device: ExerciseModerate intensity cycling for 30 minutes. |
| Hot water immersion | Active comparator | Device: Hot water immersionWhole-body hot water immersion for 30 minutes, followed by a 10-minute transfer period and then an additional 30 minutes of whole-body hot water immersion. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post exercise hot water immersionParticipants will complete 30 minutes of cycling on a lode bicycle ergometer (50% of VO2max), followed by a 10-minute transfer period and then 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C). | Device | Post exercise hot water immersion |
| ExerciseParticipants will complete 30 minutes of cycling on a lode bicycle ergometer (50% of VO2max). | Device | Exercise |
| Hot water immersionParticipants will complete 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C), followed by a 10-minute transfer period and then an additional 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C). | Device | Hot water immersion |
Primary outcome
Change in circulating plasma nitrite (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Venous blood sample
Change in brachial artery total shear rate (S-1)
Time frame: Measured at 0, 30, 70 and 100 minutes
Terason ultrasound recording of the brachial and superficial femoral artery
Change in brachial artery antegrade shear rate (S-1)
Time frame: Measured at 0, 30, 70 and 100 minutes
Terason ultrasound recording of the brachial and superficial femoral artery.
Change in brachial artery retrograde shear rate (S-1)
Time frame: Measured at 0, 30, 70 and 100 minutes
Terason ultrasound recording of the brachial and superficial femoral artery
Change in brachial artery diameter (mm)
Time frame: Measured at 0, 30, 70 and 100 minutes
Terason ultrasound recording of the brachial and superficial femoral artery
Change in brachial artery blood flow (ml/min)
Time frame: Measured at 0, 30, 70 and 100 minutes
Terason ultrasound recording of the brachial and superficial femoral artery.
Change in brachial artery compliance (μm/mmHg)
Time frame: Measured at 0, 30, 70 and 100 minutes
Terason ultrasound recording of the brachial artery. Brachial artery compliance will be calculated by using the change in blood volume and blood pressure
Change in systolic blood pressure (mmHg)
Time frame: Measurements taken at 10 minute intervals up to 100 minutes
Measured using an automated blood pressure cuff
Change in diastolic blood pressure (mmHg)
Time frame: Measurements taken at 10 minute intervals up to 100 minutes
Measured using an automated blood pressure cuff
Change in mean arterial pressure (mmHg)
Time frame: Measurements taken at 10 minute intervals up to 100 minutes
Measured using an automated blood pressure cuff. Mean arterial pressure will be calculated by using systolic and diastolic blood pressure
Change in pulse pressure (mmHg)
Time frame: Measurements taken at 10 minute intervals up to 100 minutes
Measured using an automated blood pressure cuff. Pulse pressure will be calculated using systolic and diastolic blood pressure
14 secondary outcomes
Change in circulating serum Interleukin-6 (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Interleukin-10 (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Interleukin-8 (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Interleukin-1Ra (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Vascular endothelial growth factor (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Endothelin-1 (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Circulating serum Monocyte chemoattractant protein-1 (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Matrix metallopeptidase-2 (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Change in circulating serum Matrix metallopeptidase-9 (pg/ml)
Time frame: Measured at 0, 30, 70 and 100 minutes
Energy expenditure (kcal/h-1)
Time frame: Gas measurements taken continually up to 70 minutes. Energy expenditure calculated from the 30 minutes of exercise, hot water immersion and/or rest periods.
Change in thermal comfort
Time frame: Measured at 10 minute intervals up to 100 minutes
Change in thermal sensation
Time frame: Measured at 10 minute intervals up to 100 minutes
Change in basic affect
Time frame: Measured at 10 minute intervals up to 100 minutes
Change in physical activity enjoyment scale
Time frame: Measured ~12 minutes post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post exercise hot water immersion, Exercise and Hot water immersion in people with Healthy Aging, run by Coventry University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating plasma nitrite (pg/ml) (time frame: Measured at 0, 30, 70 and 100 minutes). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.