Effect of Strength Training on Sleep Apnea in the Elderly

October 19, 2017 updated by: Hospital de Clinicas de Porto Alegre
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnea (OSA) is a disorder that exposes the individual to repeated periods of hypoxia and awakenings during sleep. OSA occurs in up to one third of the population, constituting a public health problem. The prevalence of sleep apnea increases with age, reaching up to 90%. Its consequences include sympathetic nervous system activation, increased blood pressure and heart rate, myocardial contractility overload, decline in parasympathetic activity, oxidative stress, systemic inflammation, platelet activation, and impaired vascular endothelial function. OSA is a risk factor for hypertension, coronary artery disease, peripheral artery disease, heart failure, and arrhythmias. The classical treatment options for OSA are the use of continuous positive airway pressure, oral appliances for mandibular advancement, surgery, weight reduction, and lifestyle change, including recommendation of regular practice of exercise.

Physical exercise is accepted culturally and scientifically as a non-pharmacological intervention beneficial to health. Aerobic and resistance exercises improve the quality of sleep. There is evidence of improvement in the general well-being and, particularly in sleep. Promote or improve sleep through exercise is healthy, safe, and simple. A sedentary lifestyle is linked with a higher incidence and severity of sleep apnea. Increase in the number of hours of exercise reduces these problems. Exercise has been used with consistent results to treat OSA. The effect size of exercise in treatment of OSA ranges between 0.4 and 1.5 standard deviations. In a meta-analysis, totaling 129 participants, the mean effect was the reduction of 7 events per hour. Although the results of randomized clinical trials and other studies pointing to the decrease in AHI after physical training, all studies involved adult populations with an average age between 42 and 54 years. The role of exercise in the elderly with OSA, the most affected population, remains uninvestigated.

The research question is: What is the effect of strength training on the apnea-hypopnea index (AHI) in elderly with OSA? The objective of the study is to evaluate the impact of strength training on OSA in the elderly.

The trial will recruit individuals aged 65 to 80 years ascribed to a primary care unit linked to the university hospital. Individuals that accept to participate in the study, will undergo out-of-center polysomnography in order to detect and quantify the severity of OSA. Individuals with AHI between 20 and 50 events per hour will be eligible, and will be randomly allocated to the intervention or the control group. Randomization will be performed by sequence numbers generated by computer at randomization.com.

Individuals allocated to the intervention group will hold two sessions per week of strength training consisted of exercises for legs, arms, chest, back, and abdomen in the university Physical Education High School, during 12 weeks. The individuals allocated to the control group will receive advice on lifestyle and will participate in the meetings of an elderly social group in the basic health unit. All individuals from both groups will perform an evaluation consisting of body composition by bioelectrical impedance, maximum dynamic force by 1-repetition maximum strength test, quality and muscle thickness by ultrasound, and physical function by Sit-to-stand test, Timed up and go test and Handgrip strength test. All evaluations will be repeated at the end of the 12-week period.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

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

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance training
Resistance training, twice a week during 12 weeks.
Other: Resistance training
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.
Other: Advice on lifestyle
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
Patients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-hypopnea index
Time Frame: 12 weeks
Measured by out-of-center polysomnography
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: 12 weeks
Measured by 1-repetition maximum strength test
12 weeks
Muscle thickness
Time Frame: 12 weeks
Measured by ultrasound
12 weeks
Muscle quality
Time Frame: 12 weeks
Measured by ultrasound
12 weeks
Muscle strength of legs
Time Frame: 12 weeks
Measured by Sit-to-stand test
12 weeks
Mobility
Time Frame: 12 weeks
Measured by Timed up and go test
12 weeks
Grip strength
Time Frame: 12 weeks
Measured by Handgrip strength test
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: 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

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.

General Publications

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

April 1, 2016

Primary Completion (Anticipated)

November 30, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 23, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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