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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02721251
Enrollment
52
Registered
2016-03-29
Start date
2016-04-01
Completion date
2019-09-30
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Overweight

Keywords

exercise, weight loss, sleep apnea

Brief 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.

Detailed 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.

Interventions

BEHAVIORALExercise

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)

BEHAVIORALWeight Loss

16 week. the goal is 10% weight loss.

BEHAVIORALExercise + Weight Loss

Combined exercise and weight loss components of the other arms

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Apnea-hypopnea Index (AHI)Change from baseline to the end of the study (16-week intervention)Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.

Secondary

MeasureTime frameDescription
Snoring Severity ScaleChange from baseline to the end of the study (16-week intervention)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
Pittsburgh Sleep Quality Index (PSQI)Change from baseline to the end of the study (16-week intervention)Commonly used metric of sleep quality. Baseline minus end of study. Positive value indicates improvement. Minimum score: 0 Maximum score: 21
Blood PressureChange from baseline to the end of the study (16-week intervention)Blood pressure
Functional Outcomes of Sleepiness Questionnaire (FOSQ)Change from baseline to the end of the study (16-week intervention)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
Percent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)Change from baseline to the end of the study (16-week intervention)Percent body fat assessed with DEXA. Change in percent body fat - positive value represents a decrease.
C-reactive Protein (CRP)Change from baseline to the end of the study (16-week intervention)Measure of inflammation
Body WeightChange from baseline to the end of the study (16-week intervention)Fasting body weight. Weight change (kg) beginning to end of study (positive valuate = decrease)

Countries

United States

Participant flow

Recruitment details

83 signed consent. Of these, 31 did not pass screening for various reasons, and 5 participants were not able to complete screening procedures after the study was stopped. Thus, 47 participants were randomized to one of the three treatments

Pre-assignment details

Reasons for not passing screening procedures for various reasons, including insufficiently severe sleep apnea. Of the 47 participants who started one of the treatments, 24 dropped out during the study, for various reasons, including burden of the intervention, transportation difficulties, going to jail. Six other participants were excluded for non-adherence. Thus, 17 participants completed the study.

Participants by arm

ArmCount
Weight Loss
16 week intervention with a goal weight loss of 10%, accomplished with caloric and fat restriction, weekly sessions with a nutritionist, and some meal replacement Weight Loss: 16 week. the goal is 10% weight loss.
14
Exercise
16 week intervention, building up to 30-45 minutes of aerobic exercise 4 days per week, and 15 min of resistance exercise 2 days per week 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)
16
Exercise + Weight Loss
Combined components of the exercise and weight loss treatments Exercise + Weight Loss: Combined exercise and weight loss components of the other arms
17
Total47

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall Studypoor adherence222
Overall StudyWithdrawal by Subject879

Baseline characteristics

CharacteristicWeight LossExerciseExercise + Weight LossTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
14 Participants16 Participants17 Participants47 Participants
Age, Continuous50.2 years
STANDARD_DEVIATION 10.3
49.1 years
STANDARD_DEVIATION 9.7
48.2 years
STANDARD_DEVIATION 8.5
49.2 years
STANDARD_DEVIATION 9.8
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants2 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants13 Participants15 Participants41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants1 Participants2 Participants5 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants3 Participants2 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
9 Participants10 Participants13 Participants32 Participants
Region of Enrollment
United States
14 Participants16 Participants17 Participants47 Participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants4 Participants
Sex: Female, Male
Male
13 Participants15 Participants15 Participants43 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 160 / 17
other
Total, other adverse events
0 / 140 / 160 / 17
serious
Total, serious adverse events
0 / 140 / 160 / 17

Outcome results

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.

Time frame: Change from baseline to the end of the study (16-week intervention)

Population: Data on the final AHI are missing for one participants in the exercise + weight loss treatment.

ArmMeasureValue (MEAN)Dispersion
Weight LossApnea-hypopnea Index (AHI)17.8 events per hourStandard Deviation 26.9
ExerciseApnea-hypopnea Index (AHI)-4.3 events per hourStandard Deviation 8.7
Exercise + Weight LossApnea-hypopnea Index (AHI)-10.7 events per hourStandard Deviation 7
Secondary

Blood Pressure

Blood pressure

Time frame: Change from baseline to the end of the study (16-week intervention)

Population: Data missing

Secondary

Body Weight

Fasting body weight. Weight change (kg) beginning to end of study (positive valuate = decrease)

Time frame: Change from baseline to the end of the study (16-week intervention)

Population: Final body weight data are missing on n=1, 3, and 2 participants in the weight loss, exercise, and exercise + weight loss treatment, respectively.

ArmMeasureValue (MEAN)Dispersion
Weight LossBody Weight5.0 kgStandard Deviation 6.9
ExerciseBody Weight0.2 kgStandard Deviation 4.7
Exercise + Weight LossBody Weight8.0 kgStandard Deviation 10.3
Secondary

C-reactive Protein (CRP)

Measure of inflammation

Time frame: Change from baseline to the end of the study (16-week intervention)

Population: Unable to locate data

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

Time frame: Change from baseline to the end of the study (16-week intervention)

ArmMeasureValue (MEAN)Dispersion
Weight LossFunctional Outcomes of Sleepiness Questionnaire (FOSQ)-22.7 units on a scaleStandard Deviation 14.1
ExerciseFunctional Outcomes of Sleepiness Questionnaire (FOSQ)-13.6 units on a scaleStandard Deviation 19.1
Exercise + Weight LossFunctional Outcomes of Sleepiness Questionnaire (FOSQ)-0.33 units on a scaleStandard Deviation 41
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.

Time frame: Change from baseline to the end of the study (16-week intervention)

Population: Data are missing for n=2, 3, and 2 participants in the weight loss, exercise, and exercise + weight loss treatments, respectively.

ArmMeasureValue (MEAN)Dispersion
Weight LossPercent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)0.6 change in % body fatStandard Deviation 0.4
ExercisePercent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)0.8 change in % body fatStandard Deviation 0.9
Exercise + Weight LossPercent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)1.6 change in % body fatStandard Deviation 0.3
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

Time frame: Change from baseline to the end of the study (16-week intervention)

ArmMeasureValue (MEAN)Dispersion
Weight LossPittsburgh Sleep Quality Index (PSQI)0.9 units on a scaleStandard Deviation 0.6
ExercisePittsburgh Sleep Quality Index (PSQI)-0.7 units on a scaleStandard Deviation 0.6
Exercise + Weight LossPittsburgh Sleep Quality Index (PSQI)1.0 units on a scaleStandard Deviation 2.6
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

Time frame: Change from baseline to the end of the study (16-week intervention)

ArmMeasureValue (MEAN)Dispersion
Weight LossSnoring Severity Scale2.3 units on a scaleStandard Deviation 3.9
ExerciseSnoring Severity Scale1.0 units on a scaleStandard Deviation 2.2
Exercise + Weight LossSnoring Severity Scale0.3 units on a scaleStandard Deviation 2.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026