Adolescent BehaviorNCT03110731
Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents
A study testing Physical training in people with Adolescent Behavior and Sleep Disorder, run by University of Pernambuco.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adolescent Behavior, Sleep Disorder
- What is being tested?
- Physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 29 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Institutionalized adolescents (14 to 19 years of age)
Who cannot join
- refuse to participate,
- incomplete evaluation
About this study
Official title: 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.
- Conditions
- Adolescent Behavior, Sleep Disorder
- Being tested
- Physical training
- Medical subject headings
- Adolescent Behavior, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingBehavioural
Physical training (2x / week) was performed for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Physical training (2x / week) was performed for 12 weeks Receives: Behavioral: Physical training |
| Control Group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
improvement in Pittsburgh Sleep Quality Index (PSQI)
Measured: 12 weeks
Daytime sleepiness
improvement Epworth Sleepiness Scale (ESE)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Jan 2016
- Primary completion24 Dec 2016
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Pinto Pedrosa, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110731
- Sponsor's protocol ID
- STRENGTH trial
- Status last verified
- Apr 2017
- First submitted
- 1 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santiago LCS, Lyra MJ, Germano-Soares AH, Lins-Filho OL, Queiroz DR, Prazeres TMP, Mello MT, Pedrosa RP, Falcao APST, Santos MAM. Effects of Strength Training on Sleep Parameters of Adolescents: A Randomized Controlled Trial. J Strength Cond Res. 2022 May 1;36(5):1222-1227. doi: 10.1519/JSC.0000000000003629. Epub 2020 Apr 29.
PubMed 32379244
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents: A Randomized Study
- ClinicalTrials.gov ID
- NCT03110731
- Acronym / sponsor ID
- STRENGTH trial
- Conditions
- Adolescent Behavior, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 24 Dec 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical trainingPhysical training (2x / week) was performed for 12 weeks |
| Control Group | No intervention | –no intervention |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Institutionalized adolescents (14 to 19 years of age)
Key exclusion criteria (2 listed)
- refuse to participate,
- incomplete evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical trainingPhysical training (2x / week) was performed for 12 weeks | Behavioural | Intervention group |
Primary outcome
sleep quality
Time frame: 12 weeks
improvement in Pittsburgh Sleep Quality Index (PSQI)
Daytime sleepiness
Time frame: 12 weeks
improvement Epworth Sleepiness Scale (ESE)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Derived from this study: PubMed 32379244Santiago LCS, Lyra MJ, Germano-Soares AH, Lins-Filho OL, Queiroz DR, Prazeres TMP, Mello MT, Pedrosa RP, Falcao APST, Santos MAM. Effects of Strength Training on Sleep Parameters of Adolescents: A Randomized Controlled Trial. J Strength Cond Res. 2022 May 1;36(5):1222-1227. doi: 10.1519/JSC.0000000000003629. Epub 2020 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Adolescent Behavior and Sleep Disorder, run by University of Pernambuco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03110731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.