Sleep ApneaNCT02742792
Effect of Strength Training on Sleep Apnea in the Elderly
A study testing Resistance training and Advice on Lifestyle in people with Sleep Apnea, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Resistance training and Advice on Lifestyle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea
- Being tested
- Resistance training, Advice on Lifestyle
- Keywords
- sleep apnea, elderly, exercise
- Medical subject headings
- Sleep Apnea Syndromes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Resistance training, twice a week during 12 weeks. Receives: 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. Receives: Other: Advice on Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index
Measured by out-of-center polysomnography
Measured: 12 weeks
Secondary outcomes (6)
Muscle strength
Measured by 1-repetition maximum strength test
Measured: 12 weeks
Muscle thickness
Measured by ultrasound
Measured: 12 weeks
Muscle quality
Measured by ultrasound
Measured: 12 weeks
Muscle strength of legs
Measured by Sit-to-stand test
Measured: 12 weeks
Mobility
Measured by Timed up and go test
Measured: 12 weeks
Grip strength
Measured by Handgrip strength test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion30 Nov 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Martinez, PhD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742792
- Sponsor's protocol ID
- 15-0613
- Status last verified
- Oct 2017
- First submitted
- 1 Apr 2016
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35561473da 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.
PubMed 29058628
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength Training on Sleep Apnea in the Elderly
- ClinicalTrials.gov ID
- NCT02742792
- Acronym / sponsor ID
- 15-0613
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, elderly, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance trainingResistance training, twice a week during 12 weeks. |
| Advice on lifestyle | Other | Other: Advice on LifestylePatients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Being in treatment for sleep apnea
- Osteoarticular problems that compromise the exercises included in the project
- Neuromuscular Problems
- Serious illness
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingTwenty-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 | Resistance training |
| Advice on LifestylePatients 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 |
Primary outcome
Apnea-hypopnea index
Time frame: 12 weeks
Measured by out-of-center polysomnography
6 secondary outcomes
Muscle strength
Time frame: 12 weeks
Muscle thickness
Time frame: 12 weeks
Muscle quality
Time frame: 12 weeks
Muscle strength of legs
Time frame: 12 weeks
Mobility
Time frame: 12 weeks
Grip strength
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Derived from this study: PubMed 35561473da 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.
- Derived from this study: PubMed 29058628da 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Martinez, PhD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Advice on Lifestyle in people with Sleep Apnea, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742792, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017.