- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06319001
Cardiovascular Reactivity to Physical Stress (REACT)
March 11, 2024 updated by: Ann-Katrin Grotle, Western Norway University of Applied Sciences
Cardiovascular Reactivity to Physical Stress: Strategies and Mechanisms
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ann-Katrin Grotle, PhD
- Phone Number: +4790960580
- Email: ann-katrin.grotle@hvl.no
Study Contact Backup
- Name: Hege R Eriksen, PhD
- Email: hege.randi.eriksen@hvl.no
Study Locations
-
-
Vestland
-
Bergen, Vestland, Norway, 5063
- Recruiting
- Western Norway University of Applied Sciences
-
Contact:
- Ann-Katrin Grotle
- Phone Number: +4790960580
- Email: ann-katrin.grotle@hvl.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Positive stress education (PSE)
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.
|
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.
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.
|
Sham Comparator: Neutral control
To control for the PSE intervention, the participants will receive 15 min of neutral information about the effects of physical exercise on cardiovascular fitness.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure (unit: mmHg) response to laboratory stressors
Time Frame: Assessment will be completed before intervention and approximately 30 minutes after intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting blood pressure (mmHg).
Time Frame: Assessment will be completed before intervention and approximately 30 minutes after intervention
|
Assessment will be completed before intervention and approximately 30 minutes after intervention
|
|
Endothelial function (% dilation)
Time Frame: Assessment will be completed before intervention and approximately 30 minutes after intervention.
|
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.
|
Subjective ratings of expectancies (point score).
Time Frame: Assessment will be completed before intervention and approximately 30 minutes after intervention.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
February 11, 2024
First Submitted That Met QC Criteria
March 11, 2024
First Posted (Actual)
March 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2688791
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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