Effect of Strength Training on the Quality and Duration o... | NCT03110731

Studies
Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents

NCT03110731

Sponsor

University of Pernambuco

Status

Completed

Last Update Posted

Apr 13, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Adolescent Behavior
Sleep Disorder

Interventions

Physical training

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 24, 2016Actual

Completion Date

Dec 29, 2016Actual

First Submitted Date

Apr 1, 2017

First Submission Date that Met QC Criteria

Apr 5, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2017

Last Update Posted Date

Apr 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rodrigo Pinto Pedrosa, Director of Sleep and Heart Laboratory, University of PernambucoPrincipal Investigator

Lead Sponsor

University of PernambucoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Physical training (2x / week) was performed for 12 weeks	Behavioral: Physical training
Control Group	No Intervention	no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical training	Behavioral	Physical training (2x / week) was performed for 12 weeks	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sleep quality	improvement in Pittsburgh Sleep Quality Index (PSQI)	12 weeks
Daytime sleepiness	improvement Epworth Sleepiness Scale (ESE)	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Institutionalized adolescents (14 to 19 years of age)

Exclusion Criteria:

refuse to participate,
incomplete evaluation

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32379244	Derived	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.

ID	Term
D000294	Adolescent Behavior
D012893	Sleep Wake Disorders

ID	Term
D001519	Behavior
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D015444	Exercise
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena