Effect of Strength Training on Sleep Apnea in the Elderly

Sleep Apnea Clinical Trial

Official title:

Effect of Strength Training on Sleep Apnea in the Elderly

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02742792
• Other study ID #: 15-0613
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 1, 2016
• Last updated: October 19, 2017
• Start date: April 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 26
• Est. completion date: December 31, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index	Measured by out-of-center polysomnography	12 weeks
Secondary	Muscle strength	Measured by 1-repetition maximum strength test	12 weeks
Secondary	Muscle thickness	Measured by ultrasound	12 weeks
Secondary	Muscle quality	Measured by ultrasound	12 weeks
Secondary	Muscle strength of legs	Measured by Sit-to-stand test	12 weeks
Secondary	Mobility	Measured by Timed up and go test	12 weeks
Secondary	Grip strength	Measured by Handgrip strength test	12 weeks