- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03110731
Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents
April 11, 2017 updated by: Rodrigo Pinto Pedrosa, University of Pernambuco
Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents: A Randomized Study
The aim of this study was to analyze the effects of strength training on sleep quality and daytime sleepiness in institutionalized adolescents (14 to 19 years of age).
Thirty-one adolescents were randomly assigned in two sample groups: intervention group (IG, n = 19) and control group (CG, n = 12).
Anthropometric measures were performed (height and body mass) and BMI was determined.
Sleep quality and daytime sleepiness were assessed using the questionnaires, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESE), and total sleep time by accelerometer.
Physical training (2x / week) was performed for 12 weeks.
The OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES) scale was used to control the effort intensity and the exercises followed an alternate pre-follow-up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Institutionalized adolescents (14 to 19 years of age)
Exclusion Criteria:
- refuse to participate,
- incomplete evaluation
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
no intervention
|
|
|
Experimental: Intervention group
Physical training (2x / week) was performed for 12 weeks
|
Physical training (2x / week) was performed for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep quality
Time Frame: 12 weeks
|
improvement in Pittsburgh Sleep Quality Index (PSQI)
|
12 weeks
|
|
Daytime sleepiness
Time Frame: 12 weeks
|
improvement Epworth Sleepiness Scale (ESE)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
January 1, 2016
Primary Completion (Actual)
December 24, 2016
Study Completion (Actual)
December 29, 2016
Study Registration Dates
First Submitted
April 1, 2017
First Submitted That Met QC Criteria
April 5, 2017
First Posted (Actual)
April 12, 2017
Study Record Updates
Last Update Posted (Actual)
April 13, 2017
Last Update Submitted That Met QC Criteria
April 11, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STRENGTH trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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