Cardiovascular Reactivity to Physical Stress

Blood Pressure Clinical Trial

— REACT  

Official title:

Cardiovascular Reactivity to Physical Stress: Strategies and Mechanisms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319001
• Other study ID #: 2688791
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: Western Norway University of Applied Sciences
• Contact: Ann-Katrin Grotle, PhD
• Phone: +4790960580
• Email: ann-katrin.grotle[@]hvl.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Blood Pressure
• Stress, Physiological

Intervention

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

Locations

Country	Name	City	State
Norway	Western Norway University of Applied Sciences	Bergen	Vestland

Sponsors (1)

Lead Sponsor	Collaborator
Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Resting blood pressure (mmHg).		Assessment will be completed before intervention and approximately 30 minutes after intervention
Secondary	Endothelial function (% dilation)	Endothelial function will be assessed using the flow-mediated dilation technique following current guidelines.	Assessment will be completed before intervention and approximately 30 minutes after intervention.
Secondary	Subjective ratings of expectancies (point score).	Stress, pain, heat, and cold response expectancies will be assessed with single questions specifically targeted to the interventions and experimental tests using a Numeric Rating Scale (NRS) ranging from 0 = no stress, no pain, no discomfort (heat, cold) at all to 10 = worst possible pain, stress, heat/cold discomfort.	Assessment will be completed before intervention and approximately 30 minutes after intervention.