Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Obesity Weight Loss, Pulmonary, Pulmonary |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/3/2019 |
| Start Date: | April 1, 2016 |
| End Date: | March 31, 2020 |
Obstructive sleep apnea (OSA) is highly prevalent among Veterans, and is associated with
significant mortality and multiple morbidities. Available treatments have had limited
effectiveness in treating OSA and alleviating associated morbidity. The investigators'
previous research found a reduction in OSA severity of approximately 25% following modest
exercise training. That this effect occurred independent of weight loss raises the exciting
possibility that exercise combined with weight loss could reduce OSA by at least 50% and have
unique health benefits for OSA patients. Following screening and baseline assessments, 90
overweight Veterans ages 18-60 years with OSA will be randomized to one of three 16-week
treatments: (1) exercise training; (2) 10 % weight loss; and 3) exercise + weight loss.
Changes in OSA and related morbidity will be compared between treatments.
significant mortality and multiple morbidities. Available treatments have had limited
effectiveness in treating OSA and alleviating associated morbidity. The investigators'
previous research found a reduction in OSA severity of approximately 25% following modest
exercise training. That this effect occurred independent of weight loss raises the exciting
possibility that exercise combined with weight loss could reduce OSA by at least 50% and have
unique health benefits for OSA patients. Following screening and baseline assessments, 90
overweight Veterans ages 18-60 years with OSA will be randomized to one of three 16-week
treatments: (1) exercise training; (2) 10 % weight loss; and 3) exercise + weight loss.
Changes in OSA and related morbidity will be compared between treatments.
Rationale: Approximately 15-20% of adults have obstructive sleep apnea (OSA), and evidence
indicates that the prevalence of OSA is perhaps twice as high among Veterans. OSA has been
clearly linked to increased mortality and multiple morbidities, and undoubtedly contributes
to the high prevalence of health problems among Veterans. Current treatments for OSA are not
well tolerated, often have limited efficacy, and often do not result in improvements in
health. The investigators' recent research demonstrated that 12 weeks of moderate exercise
training elicited a reduction of OSA of ~25%, as well as significant improvement in mood,
fatigue, quality of life, and cardiovascular health. Interestingly, as with other health
benefits of exercise, the investigators' research is consistent with other research showing
that exercise can reduce OSA independent of changes in body weight. These studies raise the
exciting possibility that exercise training combined with modest weight loss could elicit a
chronic reduction in OSA of 50% or more.
Objectives: The investigators' Objective is to compare the effects of 16 weeks of exercise
training alone, weight loss alone, and exercise + weight loss on OSA severity and associated
morbidity.
Methods: Following extensive screening and baseline assessment, N=90 overweight/obese
Veterans (ages 18-60 years) with mild to severe OSA will be randomized to one of three
16-week treatments. (1) Exercise Alone (n=30) will involve training 4 days per week under
supervision of a clinical exercise physiologist. It will include aerobic exercise (treadmill,
cycling, elliptical) that will gradually increase to 30-45 min on 4 days/wk, as well as
resistance exercise (15 min) on 2 days/week. (2) Weight Loss Alone (n=30) will involve a
structured meal plan (including some meal replacement with shakes or bars), and weekly
counseling designed to elicit a reduction in body weight of 10%. (3) Exercise + Weight Loss
(n=30) will involve the same exercise and weight loss interventions as in the other
treatments. Outside of the interventions, participants will be asked to maintain their usual
exercise and diet habits, as verified, respectively, with actigraphic recording and a 24-hr
food recall. Before and after the treatments, participants will undergo 5 days/nights of
home-based actigraphic and diary-assessed sleep, and one night of laboratory polysomnographic
recording of sleep, including OSA severity. Comorbidity measures will include pre- to
post-treatment changes in blood pressure, glucose, insulin, lipids, hemoglobin a1c, body
weight/composition, and inflammation (e.g., CRP, IL-6). Also measured will be monthly changes
in self-reports of sleep quality, functional outcomes of sleepiness (FOSQ), and snoring
symptoms. A 3-month follow-up will include home assessment of OSA, as well as sleep quality,
FOSQ, and snoring. Mediation analysis will explore whether improvements in OSA are mediated
by changes in percent of deep sleep, body weight, trunk body fat percent, trunk total mass,
respiratory muscle strength, and upper airway obstruction assessed in the laboratory.
Implications for Future Research. Demonstration of a reduction of OSA by 50% would result in
extensive subsequent studies. These would likely include studies of dose-response effects;
comparisons of different modes of exercise; studies of the feasibility of telemedicine
approaches to the interventions; comparative efficacy studies vs. PAP; further mechanistic
studies, for example, of upper airway collapsibility and composition (e.g, via MRI); and
studies of other positive health outcomes, such as extensive heart imaging.
indicates that the prevalence of OSA is perhaps twice as high among Veterans. OSA has been
clearly linked to increased mortality and multiple morbidities, and undoubtedly contributes
to the high prevalence of health problems among Veterans. Current treatments for OSA are not
well tolerated, often have limited efficacy, and often do not result in improvements in
health. The investigators' recent research demonstrated that 12 weeks of moderate exercise
training elicited a reduction of OSA of ~25%, as well as significant improvement in mood,
fatigue, quality of life, and cardiovascular health. Interestingly, as with other health
benefits of exercise, the investigators' research is consistent with other research showing
that exercise can reduce OSA independent of changes in body weight. These studies raise the
exciting possibility that exercise training combined with modest weight loss could elicit a
chronic reduction in OSA of 50% or more.
Objectives: The investigators' Objective is to compare the effects of 16 weeks of exercise
training alone, weight loss alone, and exercise + weight loss on OSA severity and associated
morbidity.
Methods: Following extensive screening and baseline assessment, N=90 overweight/obese
Veterans (ages 18-60 years) with mild to severe OSA will be randomized to one of three
16-week treatments. (1) Exercise Alone (n=30) will involve training 4 days per week under
supervision of a clinical exercise physiologist. It will include aerobic exercise (treadmill,
cycling, elliptical) that will gradually increase to 30-45 min on 4 days/wk, as well as
resistance exercise (15 min) on 2 days/week. (2) Weight Loss Alone (n=30) will involve a
structured meal plan (including some meal replacement with shakes or bars), and weekly
counseling designed to elicit a reduction in body weight of 10%. (3) Exercise + Weight Loss
(n=30) will involve the same exercise and weight loss interventions as in the other
treatments. Outside of the interventions, participants will be asked to maintain their usual
exercise and diet habits, as verified, respectively, with actigraphic recording and a 24-hr
food recall. Before and after the treatments, participants will undergo 5 days/nights of
home-based actigraphic and diary-assessed sleep, and one night of laboratory polysomnographic
recording of sleep, including OSA severity. Comorbidity measures will include pre- to
post-treatment changes in blood pressure, glucose, insulin, lipids, hemoglobin a1c, body
weight/composition, and inflammation (e.g., CRP, IL-6). Also measured will be monthly changes
in self-reports of sleep quality, functional outcomes of sleepiness (FOSQ), and snoring
symptoms. A 3-month follow-up will include home assessment of OSA, as well as sleep quality,
FOSQ, and snoring. Mediation analysis will explore whether improvements in OSA are mediated
by changes in percent of deep sleep, body weight, trunk body fat percent, trunk total mass,
respiratory muscle strength, and upper airway obstruction assessed in the laboratory.
Implications for Future Research. Demonstration of a reduction of OSA by 50% would result in
extensive subsequent studies. These would likely include studies of dose-response effects;
comparisons of different modes of exercise; studies of the feasibility of telemedicine
approaches to the interventions; comparative efficacy studies vs. PAP; further mechanistic
studies, for example, of upper airway collapsibility and composition (e.g, via MRI); and
studies of other positive health outcomes, such as extensive heart imaging.
Inclusion Criteria:
- Veteran
- 18-65 years of age
- Moderate-severity OSA [[Apnea-hypopnea index (AHI) 15 at screening]
- Overweight/obese
- Physically inactive
- BMI 28
- Sedentary lifestyle (planned activity for purpose of health < 2 days/week)
- Stable weight Not engaged in weight loss study or program
- Stable medications Medications for thyroid, cholesterol, blood pressure, and other
conditions at same dose for 2 months
- Capable of signing consent and willing to provide informed consent and accept
randomization assignment
Exclusion Criteria:
- Current OSA treatment Current use of continuous positive airway pressure (PAP), dental
devices, etc. for OSA treatment. Past PAP or oral appliances are not exclusions if
discontinued 2 months before study
- Significant disease: known or signs/symptoms of cardiovascular, metabolic, or
pulmonary disease
- Uncontrolled hypertension: Blood pressure > 159/99 mmHg
- Unable to exercise: musculoskeletal, orthopedic, neuromuscular, or other conditions
that do not allow exercise or where exercise is contraindicated
- Any accident attributable to sleepiness in previous 3 years
- Current pregnancy/planning to become pregnant
- Clinically judged unsuitable as evaluated by supervising medical physician
We found this trial at
1
site
Phoenix, Arizona 85012
Principal Investigator: Shawn D. Youngstedt, PhD
Phone: 602-277-5551
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