NCT02742792

Brief Summary

The objective of the study is to evaluate the impact of strength training on sleep apneas in the elderly. Individuals aged between 65 and 80 years and that presenting apnea-hypopnea index between 20 and 50 events per hour, measured by out-of-center portable polysomnography, will be recruited. Those included will be randomized to two groups: Intervention: consisted of 12 weeks, twice a week, of strength training; or control: consisted of lifestyle recommendations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

April 1, 2016

Last Update Submit

October 19, 2017

Conditions

Sleep Apnea

Keywords

sleep apneaelderlyexercise

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index

    Measured by out-of-center polysomnography

    12 weeks

Secondary Outcomes (6)

  • Muscle strength

    12 weeks

  • Muscle thickness

    12 weeks

  • Muscle quality

    12 weeks

  • Muscle strength of legs

    12 weeks

  • Mobility

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Resistance training

EXPERIMENTAL

Resistance training, twice a week during 12 weeks.

Other: Resistance training

Advice on lifestyle

OTHER

Patients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital.

Other: Advice on Lifestyle

Interventions

Resistance trainingOTHER

Twenty-four strength training sessions consisted in exercises of extension and flexion knees, lat pull-down, elbow extension and flexion, sitting bench press and hip abduction.

Resistance training
Advice on LifestyleOTHER

Patients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital.

Advice on lifestyle

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age between 65 and 80 years
  • Both genders
  • Not being engaged in regular structured resistance exercise
  • Apnea-hypopnea index between 20 and 50 events per hour
  • Time availability to include physical activity in routine
  • Consenting to participate in the survey

You may not qualify if:

  • Being in treatment for sleep apnea
  • Osteoarticular problems that compromise the exercises included in the project
  • Neuromuscular Problems
  • Serious illness
  • Uncontrolled hypertension
  • Acute myocardial infarction in the last year
  • Recent trauma of the upper airway
  • Other chronic diseases in treatment for over a month in the last year
  • Drugs with effect on the central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de ClĂ­nicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (2)

  • da Silva RP, Martinez D, Uribe Ramos JM, Martins EF, Tedesco-Silva LM, Lopez P, Cadore EL. The effects of resistance exercise on obstructive sleep apnea severity and body water content in older adults: A randomized controlled trial. Sleep Med. 2022 Jul;95:37-46. doi: 10.1016/j.sleep.2022.04.014. Epub 2022 Apr 22.

    PMID: 35561473DERIVED

  • da Silva RP, Martinez D, Lopez P, Cadore EL. Effect of strength training on sleep apnea severity in the elderly: study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):489. doi: 10.1186/s13063-017-2238-3.

    PMID: 29058628DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Denis Martinez, PhD

    Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil; Cardiology Unit, Hospital de Clinicas de Porto Alegre (HCPA - UFRGS), Porto Alegre, RS, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 19, 2016

Study Start

April 1, 2016

Primary Completion

November 30, 2017

Study Completion

December 31, 2017

Last Updated

October 23, 2017

Record last verified: 2017-10

Locations

BR(1)