Cold Water Exposure and Immune Function Study
- Conditions
- Cold Water ImmersionImmune FunctionMuscular StrengthMental Health
- Registration Number
- NCT06667479
- Lead Sponsor
- University of Northern Colorado
- Brief Summary
The purpose of this clinical trial is to explore the effects of a 4 week cold-water immersion (CWI) intervention on measures of immune function, sleep quality, mental health and well-being, and muscular strength. The main questions it aims to answer are:
* Does a 4 week CWI intervention improve measures of immune function, sleep quality, mental health and well-being, and muscular strength?
* Are there any differences in these measures when comparing cold tubs versus cold showers?
Researchers will compare chronic use of cold tubs to cold showers to see if cold water immersion may improve overall immune health and well-being.
Participants will:
* Undergo 4 weeks of Cold Tub or Cold Shower interventions at a frequency of 3 times a week for 4 minutes, if placed in the CWI intervention groups
* Undergo testing measures at the two pre- and post- intervention time points, if placed in the healthy control group or the CWI intervention groups
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 75
- Males and Females
- Aged 18-45
- Currently practices CWI for [>3 times in the last month]
- Pregnant or planning to become pregnant
- Chronic use of anti-inflammatory medication
- Prior history of chronic disease conditions:
- Cardiovascular Disease
- Diabetes
- Cancer
- Raynaud's Disease
- Severe and untreated anxiety or depression
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method C-Reactive Protein Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours. Approximately 60mL of whole blood will be collected into serum separator tubes (Beckton Dickinson, East Rutherford, NJ, USA), allowed to clot for 30-min at room temperature, then centrifuged at 2000 RPM for 15 min. The serum will be pipetted into 1.5 mL microcentrifuge tubes (Eppendorf AG, Hamburg, Germany) and immediately stored in a -80 °C freezer. Serum concentrations of CRP will be determined with a commercially available enzyme-linked immunosorbent assay (ALPCO Diagnostics, Salem, NH, USA). Microplates will be read with an ELx800 BioTek microplate reader (BioTek Instruments, Inc., Winooski, VT, USA) at the recommended wavelength of 450 nanometers.
Lipopolysaccharide Binding Protein (LBP) Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours. Approximately 60mL of whole blood will be collected into serum separator tubes (Beckton Dickinson, East Rutherford, NJ, USA), allowed to clot for 30-min at room temperature, then centrifuged at 2000 RPM for 15 min. The serum will be pipetted into 1.5 mL microcentrifuge tubes (Eppendorf AG, Hamburg, Germany) and immediately stored in a -80 °C freezer. Serum concentrations of LBP will be determined with a commercially available enzyme-linked immunosorbent assay (Abcam Limited, Cambridge, UK). Microplates will be read with an ELx800 BioTek microplate reader (BioTek Instruments, Inc., Winooski, VT, USA) at the recommended wavelength of 450 nanometers.
Zonulin (Haptoglobin-2 Precursor) Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours. Approximately 60mL of whole blood will be collected into serum separator tubes (Beckton Dickinson, East Rutherford, NJ, USA), allowed to clot for 30-min at room temperature, then centrifuged at 2000 RPM for 15 min. The serum will be pipetted into 1.5 mL microcentrifuge tubes (Eppendorf AG, Hamburg, Germany) and immediately stored in a -80 °C freezer. Serum concentrations of Zonulin will be determined with a commercially available enzyme-linked immunosorbent assay (Thermo Fisher Scientific, Waltham, MA, USA). Microplates will be read with an ELx800 BioTek microplate reader (BioTek Instruments, Inc., Winooski, VT, USA) at the recommended wavelength of 450 nanometers.
Interleukin-6 (IL-6) Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours. Approximately 60mL of whole blood will be collected into serum separator tubes (Beckton Dickinson, East Rutherford, NJ, USA), allowed to clot for 30-min at room temperature, then centrifuged at 2000 RPM for 15 min. The serum will be pipetted into 1.5 mL microcentrifuge tubes (Eppendorf AG, Hamburg, Germany) and immediately stored in a -80 °C freezer. Serum concentrations of IL-6 will be determined with a commercially available enzyme-linked immunosorbent assay (Thermo Fisher Scientific, Waltham, MA, USA). Microplates will be read with an ELx800 BioTek microplate reader (BioTek Instruments, Inc., Winooski, VT, USA) at the recommended wavelength of 450 nanometers.
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index (PSQI) Visit 1A (Week 1) and 2A (Week 4): 10 minutes each Participants will be asked to complete a paper version of the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-question self-reported sleep quality tool broken up into 7 subcategories for scoring, such as subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. There are also 5 additional questions directed to the respondent's roommate or bed partner not used in the scoring, but utilized for clinical purposes.
Depression Anxiety and Stress Scales (DASS-21) Visit 1A (Week 1) and 2A (Week 4): 10 minutes each Participants will be asked to complete a paper version of the 21-item Depression Anxiety and Stress Scale (DASS-21). The DASS-21 consists of 21 questions using a 0-3 Likert scale assessing the participant's subjective mental health and stress state with a "0" indicating "Did not apply to me at all" and "3" indicating "Applied to me very much or most of the time." The DASS-21 contains 3 sub scales assessing Depression, Anxiety, and Stress consisting of 7 questions for each sub scale, where a high score of 28+ indicates "Extremely Severe" levels of Depression, a high score of 20+ indicates "Extremely Severe" levels of Anxiety, and a high score of 34+ indicates "Extremely Severe" levels of Stress, while low scores of 0-9 indicates "Normal" levels of Depression, scores of 0-7 indicates "Normal" levels of Anxiety, and scores of 0-14 indicates "Normal" levels of Stress.
Handgrip Dynamometry Visit 1B (Week 1) and Visit 2B (Week 4): 10 minutes each Isometric grip strength will be measured by a Baseline 12-0286 Electronic Smedly Hand Dynamometer (Fabrication Enterprises, White Plains, NY). To begin the test, participants will stand upright in a relaxed position; their upper extremity peak isometric grip strength will be assessed with the shoulder in 180º of flexion, elbow at full extension, and wrist and forearm in a neutral position. When prompted, participants will squeeze the device with their dominant hand, delivering a maximal effort for 3-seconds, followed by relaxation. After 30-seconds, the test will be run again. Three sets are completed for this test, and the highest value (kg) will be recorded for analysis.
Gastrointestinal Symptoms Questionairre (GSQ) Completed During Visit 1A and 2A (10 minutes) Participants will be asked to complete an online version of the Gastrointestinal Symptoms Questionnaire (GSQ). The GSQ is a 29-question self-reported gastrointestinal (GI) screening tool broken up into two subcategories for scoring, one for their GI symptoms experienced today and the other for their GI symptoms experienced in the last 4 weeks. There are also two open-ended question at the end of the survey, one describing any other GI symptoms not addressed in the questionnaire and another addressing normal food consumption. The GSQ will be completed online during Visits 1A and 2A.
Trial Locations
- Locations (1)
University of Northern Colorado - Gunter Hall
🇺🇸Greeley, Colorado, United States