The Effects of 8 Weeks Post Exercise Hot Water Immersion on Vascular and Cardiometabolic Health in Physically Inactive Middle-aged Adults

NCT05409404 | Completed

• 1 other identifier: P132234
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This research project aims to determine whether post exercise hot water immersion can improve vascular and cardiometabolic health to a greater extent than post exercise thermoneutral water immersion in healthy middle-aged adults. The study will take place over an 8 week period where participants will do a combination of aerobic exercise and water immersion 3 times per week. The study will be a randomised controlled trial comparing 8-weeks of post exercise hot water immersion (EX+HWI) to post exercise thermoneutral water immersion (EX+TNWI).

Conditions

Physical Inactivity; Aging

Outcome Measures

Primary Outcomes (25)

• Change in resting systolic blood pressure (mmHg)

  Measured using an automated blood pressure cuff

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in resting diastolic blood pressure (mmHg)

  Measured using an automated blood pressure cuff

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in resting mean arterial blood pressure (mmHg)

  Measured using an automated blood pressure cuff

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in flow mediated dilation (%)

  Terason ultrasound recording after brachial artery occlusion

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in pulse wave velocity (ms-1)

  SphygmoCor XCEL measuring carotid to femoral arterial stiffness

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in intima-media thickness (mm)

  Terason ultrasound image to measure wall thickness from the lumen-intima interface to the media-adventitia interface of the brachial and femoral arteries

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in beta stifnness index

  Calculated using systolic, diastolic blood pressure from automated blood pressure cuff and vessel diameter from Terason ultrasound image of brachial and femoral arteries

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in dynamic arterial compliance (mm2)

  Calculated using pulse pressure from automated blood pressure cuff and vessel diameter from Terasol ultrasound image of brachial and femoral arteries

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in maximal oxygen uptake (ml/kg/min)

  Maximal oxygen uptake

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in glucose tolerance (mmol/L)

  Oral glucose tolerance test through fingertip capillary blood samples at 15 minute intervals for the first 1 hour and 30 minute intervals for the second hour

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating serum Interleukin-6 (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating serum TNF-α (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating serum Interleukin-8 (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating serum Interleukin-10 (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating serum Interleukin-1Ra (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating Endothelin-1 (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Circulating serum Monocyte chemoattractant protein-1 (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating serum Matrix metallopeptidase-2 (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating serum Matrix metallopeptidase-9 (pg/ml)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating total cholesterol (mmol/L)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating low density lipoproteins (mmol/L)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating high density lipoproteins (mmol/L)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating Triglycerides (mmol/L)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating glycated haemoglobin (%)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in circulating basal glucose (mmol/L)

  Venous blood sample

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

Secondary Outcomes (8)

• Change in Framingham risk score

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in rectal core temperature (°C)

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in resting heart rate (bpm)

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Body mass index (kg/m²)

  Measurements taken the week before the study, >48hrs after 4 weeks and >48hrs after 8 weeks

• Change in thermal comfort

  Measurements taken pre and post visit 1, 12 (4 weeks) and 24 (8 weeks)

Study Arms (2)

Aerobic exercise + hot water immersion

EXPERIMENTAL

3 sessions per week, over an 8 week period, with each session consisting of 30 minutes of aerobic exercise (10 minutes cycling, jogging and rowing) at a power output equivalent to 65-75% of maximal heart rate followed by 30 minutes of whole body hot water immersion at 40°C.

Other: Aerobic exercise + hot water immersion

Aerobic exercise + thermoneutral water immersion

ACTIVE COMPARATOR

3 sessions per week, over an 8 week period, with each session consisting of 30 minutes of aerobic exercise (10 minutes cycling, jogging and rowing) at a power output equivalent to 65-75% of maximal heart rate followed by 30 minutes of whole body water immersion at 34°C.

Other: Aerobic exercise + thermoneutral water immersion

Interventions

Aerobic exercise + hot water immersion OTHER

Light to moderate intensity aerobic exercise for 30 minutes, followed by 30 minutes of hot water immersion at 40°C.

Aerobic exercise + hot water immersion

Aerobic exercise + thermoneutral water immersion OTHER

Light to moderate intensity aerobic exercise for 30 minutes, followed by 30 minutes of thermoneutral water immersion at 34°C.

Aerobic exercise + thermoneutral water immersion

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 45 - 65 years
• If female and post-menopausal (12 months without a period and not taking HRT)
• Body mass index (BMI) 18.5 - 34.9kg/m2
• Participated in less than 150 mins of moderate intensity physical activity or 75 mins of vigorous or a combination of both over the last 6 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Coventry University: lead
• British Society for Research on Ageing: collaborator

Study Sites (1)

Coventry University

Coventry, West Midlands, CV1 5FB, United Kingdom

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Research Student

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: June 8, 2022
• Study Start: January 13, 2023
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)