- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06606626
Sleep and Resistance Exercise
Relationship Between Sleep Time and Quality With the Production of Force, Power, and Muscular Endurance.
Introduction: Despite the awareness of the importance of sleep in our lives, especially for athletes, the consequences of poor rest on sports performance are not well understood. Furthermore, the interaction between complete and partial sleep deprivation over one night and sleeping the usual hours for each person remains unclear.
Objectives: The aim of this study is to evaluate the effects of sleep deprivation on the production of strength, power, and muscular endurance according to sex (men vs. women) and type of exercise (bench press vs. squat). Additionally, the study will analyze the effects of sleep deprivation on perceived fatigue, mood, dietary habits, electrical activity, resting metabolic rate (RMR), and maximal fat oxidation (MFO).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcalá de Henares, Madrid, Spain, 28805
- Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 35 years.
- Body Mass Index (BMI) < 25 kg/m².
- Resistance-trained individuals (more than 2 years of structured training).
- Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising.
- Participants must be able to perform the tests described in the following section.
Exclusion Criteria:
- History of neuromuscular diseases, heart disease, or conditions that may affect liver or muscle metabolism.
- Use of drugs, stimulants, or sports supplements that could interfere with the dietary supplement used in the study.
- Sedentary habits (less than 150 minutes/week of moderate exercise).
- Having undergone prolonged periods of physical inactivity in the 6 months prior to the study.
- Engaging in strenuous exercise within 48 hours prior to the tests.
- Failure to replicate the same food intake on both experimental days.
- Consumption of caffeine or any other stimulant the day before the tests.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 8h Sleep (at home)
Participants sleep 8h at home
|
8h sleep at home or in the laboratory
|
|
Experimental: 8h Sleep (Laboratory)
Participants sleep 8h in the lab
|
8h sleep at home or in the laboratory
Partial (4h) or total (0h) sleep deprivation
|
|
Experimental: 4h Sleep (Laboratory)
Participants sleep 4h in the laboratory
|
Partial (4h) or total (0h) sleep deprivation
|
|
Experimental: 0h Sleep (Laboratory)
Participants sleep 0h in the laboratory
|
Partial (4h) or total (0h) sleep deprivation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean velocity at different %1RM
Time Frame: Through study completion, an average of 4 weeks
|
Measuring bar mean velocity desplacement during bench press and back squat exercises.
|
Through study completion, an average of 4 weeks
|
|
Peak velocity at different %1RM
Time Frame: Through study completion, an average of 4 weeks
|
Measuring bar peak velocity and time to reach peak velocity of bar desplacement during bench press and back squat exercises.
|
Through study completion, an average of 4 weeks
|
|
Mean power output at different %1RM
Time Frame: Through study completion, an average of 4 weeks
|
Measuring during bench press and back squat exercises.
|
Through study completion, an average of 4 weeks
|
|
Peak power output and time to reach peak power output at different %1RM
Time Frame: Through study completion, an average of 4 weeks
|
Measuring during bench press and back squat exercises.
|
Through study completion, an average of 4 weeks
|
|
Bar velocity deplacement performed in 1 set at 65%1RM until task failure
Time Frame: Through study completion, an average of 4 weeks
|
In bench press and back squat exercises
|
Through study completion, an average of 4 weeks
|
|
Power output generated in 1 set at 65%1RM until task failure
Time Frame: Through study completion, an average of 4 weeks
|
In bench press and back squat exercise
|
Through study completion, an average of 4 weeks
|
|
Number of repetitions performed at 65%1RM until task failure
Time Frame: Through study completion, an average of 4 weeks
|
In bench press and back squat exercises
|
Through study completion, an average of 4 weeks
|
|
Resting Metabolic Rate (RMR)
Time Frame: Through study completion, an average of 4 weeks
|
Kcal at rest measuring a metabolic chart
|
Through study completion, an average of 4 weeks
|
|
Maximal Fat Oxidation Rate
Time Frame: Through study completion, an average of 4 weeks
|
g/min using a metabolic chart
|
Through study completion, an average of 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat mass
Time Frame: Through study completion, an average of 4 weeks
|
Using electrical bioimpedance (kg and % of body mass)
|
Through study completion, an average of 4 weeks
|
|
Fat-free mass
Time Frame: Through study completion, an average of 4 weeks
|
Using electrical bioimpedance (kg and % of body mass)
|
Through study completion, an average of 4 weeks
|
|
Physical activity (METs-min/wk)
Time Frame: Before each trial, during the 4 weeks
|
Using IPAQ
|
Before each trial, during the 4 weeks
|
|
Dietary habits (g/kg of macronutrients)
Time Frame: Before each trial, during the 4 weeks
|
Using a 24-total recall
|
Before each trial, during the 4 weeks
|
|
Mood state (tension, depression, anger, vigor, fatigue and confusion)
Time Frame: Through study completion, an average of 4 weeks
|
Participants graded a set of 29 items related to the mood on a Likert scale from 0 (not at all) to 4 (extremely) in reply to the question;How do you feel at this moment?; to assess six scales: tension, depression, anger, vigor, fatigue and confusion.
|
Through study completion, an average of 4 weeks
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEID/2023/6/119
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
product manufactured in and exported from the U.S.
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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