- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05401396
Swimming Immediately After Having a Meal
Swimming Immediately After Having a Meal: a Randomized Controlled Study
Many believe that it is unsafe to swim immediately after having a meal and that it is preferable to wait at least 30 minutes. The fear is that swimming can cause stomach cramps and muscle cramps with discomfort and potentially drowning.
With this randomized controlled trial, the aim was to investigate whether there was any hold in this belief and what could potentially happen by swimming with the stomach full immediately after a meal.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All volunteers will be adults. Participants will receive both oral and written information about the trial prior to giving consent for participation.
Participants will act as their own control over two days. On the first day, participants will be randomized to either swim immediately after they have eaten their usual lunch or 30 minutes after the last bite. They will do the opposite on the second day. The randomization will be done by throwing a dice.
Prior to swimming, participants will fill out the following:
- Visual analogue scale (VAS) about their well-being
- Questionnaire about their mood state
After swimming, participants will fill out the following:
- Visual analogue scale (VAS) about their well-being
- Questionnaire about their mood state
- Adverse events
Prior to swimming and afterwards, the participants' blood pressure, pulse, and blood oxygen levels will be measured.
Sample size: Convenience sample.
Withdrawal and dropout criteria: All participants will be informed that they can withdraw their consent at any point during the trial without having to explain any reasons.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Herlev, Denmark, 2730
- Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥18 years
- Healthy volunteers
- Otherwise, no restriction since each participant acts as their own control
Exclusion Criteria:
- Smoking one hour prior to swimming
- Participants who cannot swim
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Swimming immediately after eating
Two arms but all participants are performing both the intervention and the comparison.
|
After having the last bite of lunch, the participants will swim in the pool with a specific distance.
|
No Intervention: Swimming 30 minutes after eating
Two arms but all participants are performing both the intervention and the comparison.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of mortality
Time Frame: During swimming
|
Any adverse events leading to death
|
During swimming
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swimming time
Time Frame: During swimming
|
Measured by seconds
|
During swimming
|
Number of patients with any adverse events
Time Frame: During and immediately after swimming is completed
|
Any adverse events other than already mentioned outcomes
|
During and immediately after swimming is completed
|
Discomfort
Time Frame: During the actual swimming and immediately after swimming is completed
|
Self-reported assessment of discomfort on a visual analogue scale.
Minimum: 0. To Maximum: 100mm.
Ranging from no discomfort to the worse imaginable discomfort.
|
During the actual swimming and immediately after swimming is completed
|
Mood changes
Time Frame: Baseline and immediately after swimming
|
Measured by the Profile of mood states.
A five-point scale indicating the level of affection.
Minimum: 1.
To Maximum: 5.
|
Baseline and immediately after swimming
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 052022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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