NCT05035004

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

August 6, 2021

Last Update Submit

March 16, 2022

Conditions

Outcome Measures

Primary Outcomes (11)

  • Change in circulating plasma nitrite (pg/ml)

    Venous blood sample

    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 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 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 at 0, 30, 70 and 100 minutes

  • Change in brachial artery diameter (mm)

    Terason ultrasound recording of the brachial and superficial femoral artery

    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 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 at 0, 30, 70 and 100 minutes

  • Change in systolic blood pressure (mmHg)

    Measured using an automated blood pressure cuff

    Measurements taken at 10 minute intervals up to 100 minutes

  • Change in diastolic blood pressure (mmHg)

    Measured using an automated blood pressure cuff

    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

    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

    Measurements taken at 10 minute intervals up to 100 minutes

Secondary Outcomes (14)

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

    Measured at 0, 30, 70 and 100 minutes

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

    Measured at 0, 30, 70 and 100 minutes

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

    Measured at 0, 30, 70 and 100 minutes

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

    Measured at 0, 30, 70 and 100 minutes

  • Change in circulating serum Vascular endothelial growth factor (pg/ml)

    Measured at 0, 30, 70 and 100 minutes

  • +9 more secondary outcomes

Other Outcomes (4)

  • Change in rectal core temperature (°C)

    Measurements taken at 10 minute intervals up to 100 minutes

  • Change in forehead skin temperature (°C)

    Measurements taken at 10 minute intervals up to 100 minutes

  • Change in heart rate (bpm)

    Measurements taken at 10 minute intervals up to 100 minutes

  • +1 more other outcomes

Study Arms (3)

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.

Device: Post exercise hot water immersion

Exercise

ACTIVE COMPARATOR

Moderate intensity cycling for 30 minutes.

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.

Device: Hot water immersion

Interventions

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).

Post exercise hot water immersion
ExerciseDEVICE

Participants will complete 30 minutes of cycling on a lode bicycle ergometer (50% of VO2max).

Exercise

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).

Hot water immersion

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coventry University

Coventry, West Midlands, CV1 5FB, United Kingdom

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Research Student in the Centre for Sport, Exercise and Life Sciences

Study Record Dates

First Submitted

August 6, 2021

First Posted

September 5, 2021

Study Start

November 15, 2021

Primary Completion

March 16, 2022

Study Completion

March 16, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations