Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT02721251
Status:
TERMINATED
Last Update Posted:
2021-05-06
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.thompson4@va.gov', 'phone': '602-496-0242', 'title': 'David Thompson', 'organization': 'VA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'VA procedures', 'eventGroups': [{'id': 'EG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Apnea-hypopnea Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': '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.'}, {'id': 'OG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'OG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '-10.7', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on the final AHI are missing for one participants in the exercise + weight loss treatment.'}, {'type': 'SECONDARY', 'title': 'Functional Outcomes of Sleepiness Questionnaire (FOSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'OG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'OG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.7', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '-13.6', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '41.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Measures impairments in functioning associated with sleepiness. Baseline minus end of study value. Positive value indicates improvement; negative value indicates worsening.\n\nMinimum score on scale: 0 Maximum score: 120', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Snoring Severity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'OG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'OG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Questionnaire that measures severity of snoring with a questionnaire. A positive value indicates improvement; a negative value indicates worsening.\n\nMinimum score: 0 Maximum score: 9', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'OG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'OG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Commonly used metric of sleep quality. Baseline minus end of study. Positive value indicates improvement.\n\nMinimum score: 0 Maximum score: 21', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'OG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'OG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Blood pressure', 'reportingStatus': 'POSTED', 'populationDescription': 'Data missing'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'OG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'OG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '10.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Fasting body weight. Weight change (kg) beginning to end of study (positive valuate = decrease)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Final body weight data are missing on n=1, 3, and 2 participants in the weight loss, exercise, and exercise + weight loss treatment, respectively.'}, {'type': 'SECONDARY', 'title': 'Percent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'OG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'OG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Percent body fat assessed with DEXA. Change in percent body fat - positive value represents a decrease.', 'unitOfMeasure': 'change in % body fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are missing for n=2, 3, and 2 participants in the weight loss, exercise, and exercise + weight loss treatments, respectively.'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'OG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'OG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Measure of inflammation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to locate data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'FG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'FG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'poor adherence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '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', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Weight Loss', 'description': '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\n\nWeight Loss: 16 week. the goal is 10% weight loss.'}, {'id': 'BG001', 'title': 'Exercise', 'description': '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\n\nExercise: 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)'}, {'id': 'BG002', 'title': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments\n\nExercise + Weight Loss: Combined exercise and weight loss components of the other arms'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '49.1', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '48.2', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '49.2', 'spread': '9.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Information on those who started the intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-04', 'size': 626418, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-01T17:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'Behind enrollment targets', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-09', 'studyFirstSubmitDate': '2016-02-17', 'resultsFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-09', 'studyFirstPostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-hypopnea Index (AHI)', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.'}], 'secondaryOutcomes': [{'measure': 'Functional Outcomes of Sleepiness Questionnaire (FOSQ)', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Measures impairments in functioning associated with sleepiness. Baseline minus end of study value. Positive value indicates improvement; negative value indicates worsening.\n\nMinimum score on scale: 0 Maximum score: 120'}, {'measure': 'Snoring Severity Scale', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Questionnaire that measures severity of snoring with a questionnaire. A positive value indicates improvement; a negative value indicates worsening.\n\nMinimum score: 0 Maximum score: 9'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Commonly used metric of sleep quality. Baseline minus end of study. Positive value indicates improvement.\n\nMinimum score: 0 Maximum score: 21'}, {'measure': 'Blood Pressure', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Blood pressure'}, {'measure': 'Body Weight', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Fasting body weight. Weight change (kg) beginning to end of study (positive valuate = decrease)'}, {'measure': 'Percent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Percent body fat assessed with DEXA. Change in percent body fat - positive value represents a decrease.'}, {'measure': 'C-reactive Protein (CRP)', 'timeFrame': 'Change from baseline to the end of the study (16-week intervention)', 'description': 'Measure of inflammation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'weight loss', 'sleep apnea'], 'conditions': ['Obstructive Sleep Apnea', 'Overweight']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nObjectives: 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.\n\nMethods: 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.\n\nImplications 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran\n* 18-65 years of age\n* Moderate-severity OSA \\[\\[Apnea-hypopnea index (AHI) 15 at screening\\]\n* Overweight/obese\n* Physically inactive\n* BMI 28\n* Sedentary lifestyle (planned activity for purpose of health \\< 2 days/week)\n* Stable weight Not engaged in weight loss study or program\n* Stable medications Medications for thyroid, cholesterol, blood pressure, and other conditions at same dose for 2 months\n* Capable of signing consent and willing to provide informed consent and accept randomization assignment\n\nExclusion Criteria:\n\n* 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\n* Significant disease: known or signs/symptoms of cardiovascular, metabolic, or pulmonary disease\n* Uncontrolled hypertension: Blood pressure \\> 159/99 mmHg\n* Unable to exercise: musculoskeletal, orthopedic, neuromuscular, or other conditions that do not allow exercise or where exercise is contraindicated\n* Any accident attributable to sleepiness in previous 3 years\n* Current pregnancy/planning to become pregnant\n* Clinically judged unsuitable as evaluated by supervising medical physician'}, 'identificationModule': {'nctId': 'NCT02721251', 'briefTitle': 'Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea', 'orgStudyIdInfo': {'id': 'CLNB-012-14S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': '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', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Weight Loss', 'description': '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', 'interventionNames': ['Behavioral: Weight Loss']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise + Weight Loss', 'description': 'Combined components of the exercise and weight loss treatments', 'interventionNames': ['Behavioral: Exercise + Weight Loss']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '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)', 'armGroupLabels': ['Exercise']}, {'name': 'Weight Loss', 'type': 'BEHAVIORAL', 'description': '16 week. the goal is 10% weight loss.', 'armGroupLabels': ['Weight Loss']}, {'name': 'Exercise + Weight Loss', 'type': 'BEHAVIORAL', 'description': 'Combined exercise and weight loss components of the other arms', 'armGroupLabels': ['Exercise + Weight Loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix VA Health Care System, Phoenix, AZ', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Shawn D. Youngstedt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Phoenix VA Health Care System, Phoenix, AZ'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}