NCT03110731

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

April 1, 2017

Last Update Submit

April 11, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • sleep quality

    improvement in Pittsburgh Sleep Quality Index (PSQI)

    12 weeks

  • Daytime sleepiness

    improvement Epworth Sleepiness Scale (ESE)

    12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Physical training (2x / week) was performed for 12 weeks

Behavioral: Physical training

Control Group

NO INTERVENTION

no intervention

Interventions

Physical training (2x / week) was performed for 12 weeks

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Institutionalized adolescents (14 to 19 years of age)

You may not qualify if:

  • refuse to participate,
  • incomplete evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Adolescent BehaviorSleep Wake Disorders

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

BehaviorNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Sleep and Heart Laboratory

Study Record Dates

First Submitted

April 1, 2017

First Posted

April 12, 2017

Study Start

January 1, 2016

Primary Completion

December 24, 2016

Study Completion

December 29, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share