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Effect of Strength Training on Sleep Apnea in the Elderly

Primary Purpose

Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance training
Advice on Lifestyle
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea, elderly, exercise

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Resistance training

Advice on lifestyle

Arm Description

Resistance training, twice a week during 12 weeks.

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

Outcomes

Primary Outcome Measures

Apnea-hypopnea index
Measured by out-of-center polysomnography

Secondary Outcome Measures

Muscle strength
Measured by 1-repetition maximum strength test
Muscle thickness
Measured by ultrasound
Muscle quality
Measured by ultrasound
Muscle strength of legs
Measured by Sit-to-stand test
Mobility
Measured by Timed up and go test
Grip strength
Measured by Handgrip strength test

Full Information

First Posted
April 1, 2016
Last Updated
October 19, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02742792
Brief Title
Effect of Strength Training on Sleep Apnea in the Elderly
Official Title
Effect of Strength Training on Sleep Apnea in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
sleep apnea, elderly, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance training
Arm Type
Experimental
Arm Description
Resistance training, twice a week during 12 weeks.
Arm Title
Advice on lifestyle
Arm Type
Other
Arm Description
Patients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital.
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Advice on Lifestyle
Intervention Description
Patients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital.
Primary Outcome Measure Information:
Title
Apnea-hypopnea index
Description
Measured by out-of-center polysomnography
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Measured by 1-repetition maximum strength test
Time Frame
12 weeks
Title
Muscle thickness
Description
Measured by ultrasound
Time Frame
12 weeks
Title
Muscle quality
Description
Measured by ultrasound
Time Frame
12 weeks
Title
Muscle strength of legs
Description
Measured by Sit-to-stand test
Time Frame
12 weeks
Title
Mobility
Description
Measured by Timed up and go test
Time Frame
12 weeks
Title
Grip strength
Description
Measured by Handgrip strength test
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Martinez, PhD
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35561473
Citation
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.
Results Reference
derived
PubMed Identifier
29058628
Citation
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.
Results Reference
derived

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Effect of Strength Training on Sleep Apnea in the Elderly

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