Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea

Overweight Clinical Trial

Official title:

Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02721251
• Other study ID #: CLNB-012-14S
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: April 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Overweight
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Weight Loss

Intervention

Behavioral:
• Exercise
16 weeks. 4 days per week of aerobic exercise; 45 min for 2 days and for 30 min for two days. 2 days per week of resistance exercise for 15 min (coinciding with the days involving 30 min of aerobic exercise)
• Weight Loss
16 week. the goal is 10% weight loss.
• Exercise + Weight Loss
Combined exercise and weight loss components of the other arms

Locations

Country	Name	City	State
United States	Phoenix VA Health Care System, Phoenix, AZ	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea Index (AHI)	Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.	Change from baseline to the end of the study (16-week intervention)
Secondary	Functional Outcomes of Sleepiness Questionnaire (FOSQ)	Measures impairments in functioning associated with sleepiness. Baseline minus end of study value. Positive value indicates improvement; negative value indicates worsening.; Minimum score on scale: 0 Maximum score: 120	Change from baseline to the end of the study (16-week intervention)
Secondary	Snoring Severity Scale	Questionnaire that measures severity of snoring with a questionnaire. A positive value indicates improvement; a negative value indicates worsening.; Minimum score: 0 Maximum score: 9	Change from baseline to the end of the study (16-week intervention)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Commonly used metric of sleep quality. Baseline minus end of study. Positive value indicates improvement.; Minimum score: 0 Maximum score: 21	Change from baseline to the end of the study (16-week intervention)
Secondary	Blood Pressure	Blood pressure	Change from baseline to the end of the study (16-week intervention)
Secondary	Body Weight	Fasting body weight. Weight change (kg) beginning to end of study (positive valuate = decrease)	Change from baseline to the end of the study (16-week intervention)
Secondary	Percent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)	Percent body fat assessed with DEXA. Change in percent body fat - positive value represents a decrease.	Change from baseline to the end of the study (16-week intervention)
Secondary	C-reactive Protein (CRP)	Measure of inflammation	Change from baseline to the end of the study (16-week intervention)