Clinical trial NCT06667193: Cold Water Exposure's Effects on Physical and Mental Health
Official title: Cold-Water Immersion's Effects on Physical and Mental Health: a 4-Week Randomized Trial Comparing Cold Tub Versus Cold Shower
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cold Exposure
Keywords: Cold Water Immersion
Cold Tub
Cold Shower
Lead sponsor: University of Northern Colorado
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, randomized design, matched for biological age
Primary purpose: OTHER

Brief summary: An interest in cold-water immersion (CWI) to elicit diverse physiological effects has been prevalent for centuries. CWI typically consists of bodily exposure to water at temperatures ranging from 5-10º C for various durations. CWI has profound cultural significance in different areas of the world, such as in Scandinavian countries, and has emerged as a popular modality for its purported health-promoting effects. Individuals on social media have repeatedly advocated for CWI as a method to improve muscular recovery, enhance sleep, and increase immune and cognitive function. Because of this, companies that specialize in cold tub production have become popularized; however, individuals who are seeking a more cost-effective option are drawn toward cold showers for their preferred method of cold exposure. Despite the scarcity of rigorous research investigating the difference in effects of cold tub versus cold shower CWI, individuals on social media promoting CWI via a shower continue to praise its comparable benefits to that of a tub. Therefore, investigations of chronic CWI (utilizing both a cold tub and a cold shower) is vital.

Thus, the purpose of the proposed study is to explore the varying effects of chronic CWI on neural and cognitive function using a cold tub and a cold shower. Further, the study aims to investigate performance measures and immune measures to create a comprehensive understanding of CWI's implications on human physiology over time. The investigators hypothesize measures relating to mental performance and health will improve after 4-weeks of CWI, and there will be no difference between tub and shower immersion groups.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged 18-45

Exclusion Criteria:

* Current holds a cold water exposure routine (≥3 sessions in the last month, consisting of ≥4 minutes per immersion)
* Currently pregnant of planning to become pregnant
* Chronic use of anti-inflammatory medication
* Prior history of chronic disease conditions: Cardiovascular Disease, Diabetes, Cancer, Raynaud's Disease, or severe/untreated anxiety or depression

Primary outcomes:
measure: Sustained Attention to Response Task (SART)
timeFrame: Visit 1B (Week 1) and Visit 2B (Week 4)
measure: Alternate Use Task (AUT)
timeFrame: Visit 1B (Week 1) and Visit 2B (Week 4)
measure: Piper Fatigue Scale (PFS)
timeFrame: Visit 1B (Week 1) and Visit 2B (Week 4)
measure: Perceived Stress Scale (PSS)
timeFrame: Visit 1B (Week 1) and Visit 2B (Week 4)
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Visit 1B (Week 1) and Visit 2B (Week 4)
measure: Heart Rate Variability (HRV)
timeFrame: Visit 1B (Week 1) and Visit 2B (Week 4)
measure: Handgrip Dynamometry
timeFrame: Visit 1B (Week 1) and Visit 2B (Week 4)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Serum Analysis - Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Serum Analysis - Cortisol
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Serum Analysis - Nerve Growth Factor (NGF)
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
Secondary outcomes:
measure: Anthropometric Measures - Height
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Anthropometric Measures - Weight
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Anthropometric Measures - Lean Body Mass
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Anthropometric Measures - Body Fat Percentage
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Hydration
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Qualitative Assessment
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4)
measure: Visual Analogue Scale (VAS) of Discomfort
timeFrame: Every water immersion visit (days 1-12; 3 days per week for 4 weeks)
Other outcomes:
Locations:
city: Greeley
country: United States
facility: University of Northern Colorado
state: Colorado
Study officials:
References: