NCT06319001

Brief Summary

It is well-accepted that an exaggerated blood pressure (BP) response to physical stress has a prognostic value, indicating a higher cardiovascular risk (e.g., sudden cardiac death, myocardial infarction, future hypertension, and left ventricular hypertrophy). However, there is a limited understanding of the underlying mechanisms and therapuetic strategies modulating this response. Therefore, this pilot project aims to explore whether one session of low-volume high-intensity interval training (low-volume HIIT) or combined intermittent heat and cold bath (sauna+cold bath) can decrease BP responses to physical stress. Furthermore, the secondary goal is to investigate whether one brief session learning about positive stress expectations magnifies the decrease in BP following low-volume HIIT and sauna+ cold bath.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

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

February 11, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 19, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

February 11, 2024

Last Update Submit

March 8, 2026

Conditions

Keywords

Cardiovascular reactivityNeural control of blood pressureMetaboreflexCold pressor response

Outcome Measures

Primary Outcomes (1)

  • Blood pressure (unit: mmHg) response to laboratory stressors

    Response will be calculated as the change from baseline to peak. Stressors employed include handgrip exercise, post-exercise ischemia, and cold pressor test.

    Assessment will be completed before intervention and approximately 30 minutes after intervention

Secondary Outcomes (3)

  • Resting blood pressure (mmHg).

    Assessment will be completed before intervention and approximately 30 minutes after intervention

  • Endothelial function (% dilation)

    Assessment will be completed before intervention and approximately 30 minutes after intervention.

  • Subjective ratings of expectancies (point score).

    Assessment will be completed before intervention and approximately 30 minutes after intervention.

Study Arms (2)

Positive stress education (PSE)

EXPERIMENTAL

This intervention will consist of standardized information about the relationships between expectations and the stress response. Using the CATS as a theoretical framework, the participants will be explained that when people face stressors, i.e., pain, heat, and cold water, the expectations about handling the situation will influence both the experience (e.g., pain) and the physiological stress response.

Other: Low-volume high intensity exerciseOther: Combined intermittent sauna and cold water bath (sauna+cold bath).

Neutral control

SHAM COMPARATOR

To control for the PSE intervention, the participants will receive 15 min of neutral information about the effects of physical exercise on cardiovascular fitness.

Other: Low-volume high intensity exerciseOther: Combined intermittent sauna and cold water bath (sauna+cold bath).

Interventions

This intervention will consist of 10 x 10-second interval sprints on a stationary bicycle interspersed with 50-second breaks between repetitions. The cycle resistance will be adjusted to the level equaling the highest power output, which will be determined during warm-up sprints.

Neutral controlPositive stress education (PSE)

This intervention will consist of 3x10 min bouts in the dry sauna interspersed with 2x 60 seconds of cold water immersion up to the neck.

Neutral controlPositive stress education (PSE)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female between 18 to 50 years
  • Non-smoker.
  • Non-obese (\<30 kg/m2).
  • Able to walk on a treadmill and cycle on a stationary bike without problems.
  • No or little (frequency \< 2 times per month) experience swimming with sauna and cold water.
  • Proficient in Norwegian and able to provide informed consent.

You may not qualify if:

  • Current or previous regular smoker
  • Addictions to alcohol or illegal drugs
  • Diagnosed with cardiovascular, respiratory, metabolic, or autoimmune diseases
  • Taking prescription medication with known cardiovascular effects
  • Judgment by a medical provider that exercise, heat therapy, or hydrotherapy poses an undue burden or risk.
  • Cognitive or psychiatric impairment
  • Lack of proficiency in Norwegian language oral or writing skills that will hamper the ability to participate in the interventions and fill out questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Norway University of Applied Sciences

Bergen, Vestland, 5063, Norway

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Combined randomized controlled trial with two parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 11, 2024

First Posted

March 19, 2024

Study Start

February 19, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations