Trial Outcomes & Findings for Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea (NCT NCT02721251)
NCT ID: NCT02721251
Last Updated: 2021-05-06
Results Overview
Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Change from baseline to the end of the study (16-week intervention)
Results posted on
2021-05-06
Participant Flow
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
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.
Participant milestones
| Measure |
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.
|
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)
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
17
|
|
Overall Study
COMPLETED
|
4
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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)
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
9
|
|
Overall Study
poor adherence
|
2
|
2
|
2
|
Baseline Characteristics
Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea
Baseline characteristics by cohort
| Measure |
Weight Loss
n=14 Participants
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.
|
Exercise
n=16 Participants
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)
|
Exercise + Weight Loss
n=17 Participants
Combined components of the exercise and weight loss treatments
Exercise + Weight Loss: Combined exercise and weight loss components of the other arms
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
47 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 10.3 • n=39 Participants
|
49.1 years
STANDARD_DEVIATION 9.7 • n=41 Participants
|
48.2 years
STANDARD_DEVIATION 8.5 • n=35 Participants
|
49.2 years
STANDARD_DEVIATION 9.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
43 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
41 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
32 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
47 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 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.
Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.
Outcome measures
| Measure |
Weight Loss
n=4 Participants
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.
|
Exercise
n=7 Participants
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)
|
Exercise + Weight Loss
n=5 Participants
Combined components of the exercise and weight loss treatments
Exercise + Weight Loss: Combined exercise and weight loss components of the other arms
|
|---|---|---|---|
|
Apnea-hypopnea Index (AHI)
|
17.8 events per hour
Standard Deviation 26.9
|
-4.3 events per hour
Standard Deviation 8.7
|
-10.7 events per hour
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Weight Loss
n=4 Participants
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.
|
Exercise
n=7 Participants
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)
|
Exercise + Weight Loss
n=6 Participants
Combined components of the exercise and weight loss treatments
Exercise + Weight Loss: Combined exercise and weight loss components of the other arms
|
|---|---|---|---|
|
Functional Outcomes of Sleepiness Questionnaire (FOSQ)
|
-22.7 units on a scale
Standard Deviation 14.1
|
-13.6 units on a scale
Standard Deviation 19.1
|
-0.33 units on a scale
Standard Deviation 41.0
|
SECONDARY outcome
Timeframe: Change 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
Outcome measures
| Measure |
Weight Loss
n=4 Participants
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.
|
Exercise
n=7 Participants
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)
|
Exercise + Weight Loss
n=6 Participants
Combined components of the exercise and weight loss treatments
Exercise + Weight Loss: Combined exercise and weight loss components of the other arms
|
|---|---|---|---|
|
Snoring Severity Scale
|
2.3 units on a scale
Standard Deviation 3.9
|
1.0 units on a scale
Standard Deviation 2.2
|
0.3 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Weight Loss
n=4 Participants
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.
|
Exercise
n=7 Participants
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)
|
Exercise + Weight Loss
n=6 Participants
Combined components of the exercise and weight loss treatments
Exercise + Weight Loss: Combined exercise and weight loss components of the other arms
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
|
0.9 units on a scale
Standard Deviation 0.6
|
-0.7 units on a scale
Standard Deviation 0.6
|
1.0 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Change from baseline to the end of the study (16-week intervention)Population: Data missing
Blood pressure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Fasting body weight. Weight change (kg) beginning to end of study (positive valuate = decrease)
Outcome measures
| Measure |
Weight Loss
n=3 Participants
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.
|
Exercise
n=4 Participants
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)
|
Exercise + Weight Loss
n=4 Participants
Combined components of the exercise and weight loss treatments
Exercise + Weight Loss: Combined exercise and weight loss components of the other arms
|
|---|---|---|---|
|
Body Weight
|
5.0 kg
Standard Deviation 6.9
|
0.2 kg
Standard Deviation 4.7
|
8.0 kg
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 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.
Percent body fat assessed with DEXA. Change in percent body fat - positive value represents a decrease.
Outcome measures
| Measure |
Weight Loss
n=2 Participants
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.
|
Exercise
n=4 Participants
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)
|
Exercise + Weight Loss
n=4 Participants
Combined components of the exercise and weight loss treatments
Exercise + Weight Loss: Combined exercise and weight loss components of the other arms
|
|---|---|---|---|
|
Percent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)
|
0.6 change in % body fat
Standard Deviation 0.4
|
0.8 change in % body fat
Standard Deviation 0.9
|
1.6 change in % body fat
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Change from baseline to the end of the study (16-week intervention)Population: Unable to locate data
Measure of inflammation
Outcome measures
Outcome data not reported
Adverse Events
Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise + Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place