Trial Outcomes & Findings for Exercise Intolerance in Elderly Patients With HFpEF(Heart Failure With Preserved Ejection Fraction) (NCT NCT02636439)
NCT ID: NCT02636439
Last Updated: 2022-07-15
Results Overview
Peak exercise oxygen consumption (VO2) pre and post intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
20 weeks
Results posted on
2022-07-15
Participant Flow
Participant milestones
| Measure |
Dietary, and Aerobic Exercise
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
COMPLETED
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Dietary, and Aerobic Exercise
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Non-compliance
|
1
|
1
|
|
Overall Study
Personal reasons
|
2
|
0
|
Baseline Characteristics
Exercise Intolerance in Elderly Patients With HFpEF(Heart Failure With Preserved Ejection Fraction)
Baseline characteristics by cohort
| Measure |
Dietary, and Aerobic Exercise
n=44 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic and Resistance Training
n=44 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Peak exercise oxygen consumption (VO2)
|
1529 ml/min
STANDARD_DEVIATION 375 • n=5 Participants
|
1530 ml/min
STANDARD_DEVIATION 366 • n=7 Participants
|
1530 ml/min
STANDARD_DEVIATION 368 • n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Analysis completed on all participants with peak VO2 obtained (n=77).
Peak exercise oxygen consumption (VO2) pre and post intervention
Outcome measures
| Measure |
Dietary, and Aerobic Exercise
n=38 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=39 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Peak Exercise Oxygen Consumption (VO2)
|
1609 ml/min
Standard Error 24
|
1653 ml/min
Standard Error 24
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Analysis completed on all participants with DEXA measurement (n=78).
Measure skeletal muscle mass in kg by DEXA analysis pre and post intervention.
Outcome measures
| Measure |
Dietary, and Aerobic Exercise
n=38 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=40 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Skeletal Muscle Mass
|
49.4 kg
Standard Error 0.3
|
49.4 kg
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Analysis completed on all participants with thigh MRI.
Measure skeletal muscle mass by MRI analysis pre and post intervention.
Outcome measures
| Measure |
Dietary, and Aerobic Exercise
n=39 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=40 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Thigh Skeletal Muscle Mass
|
108.5 cm^2
Standard Error 1.2
|
108.9 cm^2
Standard Error 1.1
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Analysis completed on all participants with MRI measurements.
MRI skeletal muscle to intermuscular fat ratio
Outcome measures
| Measure |
Dietary, and Aerobic Exercise
n=39 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=40 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Thigh Muscle Composition
|
4.0 ratio
Standard Error 0.1
|
4.0 ratio
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Analysis completed on all participants with Biodex measures.
maximal isokinetic knee extensor strength (Newton-meters, Nm) using an isokinetic dynamometer (Biodex®)
Outcome measures
| Measure |
Dietary, and Aerobic Exercise
n=25 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=28 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Muscle Strength
|
97.5 Nm
Standard Error 2.3
|
103.9 Nm
Standard Error 2.2
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Analysis completed on all participants with MRI and Biodex measurements.
knee extensor strength to thigh muscle area assessed by MRI (Nm/cm2).
Outcome measures
| Measure |
Dietary, and Aerobic Exercise
n=25 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=27 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Muscle Quality
|
0.90 Nm/cm^2
Standard Error 0.02
|
0.97 Nm/cm^2
Standard Error 0.02
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Analysis completed on all participants with KCCQ assessment.
The KCCQ Overall Summary Summary Score is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status.
Outcome measures
| Measure |
Dietary, and Aerobic Exercise
n=38 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=41 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
|
91 score on a scale
Standard Error 2
|
87 score on a scale
Standard Error 2
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Analysis completed on all participants with SF-36 assessment.
The SF-36 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status.
Outcome measures
| Measure |
Dietary, and Aerobic Exercise
n=37 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=40 Participants
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Quality of Life Measured by Short Form 36 Item Questionnaire (SF-36)
|
47.4 score on a scale
Standard Error 1.4
|
46.9 score on a scale
Standard Error 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 20 weeksPorin citrate synthase pre and post intervention.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 20 weeksrespiratory control ratio and mitofusin 2 concentration.pre and post intervention.
Outcome measures
Outcome data not reported
Adverse Events
Dietary, and Aerobic Exercise
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Dietary, Aerobic, and Resistance Training
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dietary, and Aerobic Exercise
n=44 participants at risk
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=44 participants at risk
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
4.5%
2/44 • Number of events 2 • 20 weeks
|
|
Infections and infestations
Cellulitis
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Cardiac disorders
Heart failure exacerbation
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 2 • 20 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
General disorders
Atypical chest pain
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Gastrointestinal disorders
Rectal bleeding
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Gastrointestinal disorders
Diverticulitis
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal surgery
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
Other adverse events
| Measure |
Dietary, and Aerobic Exercise
n=44 participants at risk
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
Dietary, Aerobic, and Resistance Training
n=44 participants at risk
Intervention for diet-A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb.) weight loss per week.
Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
dietary, aerobic and resistance training: hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
dietary, and aerobic exercise: hypocaloric diet individual prescription for aerobic training.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Abscess
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Gastrointestinal disorders
acute pancreatitis
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Cardiac disorders
atrial fibrillation
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
back pain
|
13.6%
6/44 • Number of events 7 • 20 weeks
|
6.8%
3/44 • Number of events 3 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
0.00%
0/44 • 20 weeks
|
4.5%
2/44 • Number of events 2 • 20 weeks
|
|
Injury, poisoning and procedural complications
broken tooth
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Cardiac disorders
chest pain
|
4.5%
2/44 • Number of events 3 • 20 weeks
|
6.8%
3/44 • Number of events 3 • 20 weeks
|
|
Cardiac disorders
heart failure exacerbation
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
diabetic ulcer
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Gastrointestinal disorders
diarrhea
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Eye disorders
elevated ocular pressure
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Gastrointestinal disorders
esophageal spasm
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Injury, poisoning and procedural complications
fall
|
13.6%
6/44 • Number of events 7 • 20 weeks
|
13.6%
6/44 • Number of events 7 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
foot pain
|
4.5%
2/44 • Number of events 2 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Nervous system disorders
headache
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Vascular disorders
hypertension
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 2 • 20 weeks
|
|
Vascular disorders
hypotension
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
13.6%
6/44 • Number of events 7 • 20 weeks
|
|
Injury, poisoning and procedural complications
finger laceration
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
2.3%
1/44 • Number of events 2 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle strain
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
General disorders
non-cardiac chest pain
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Reproductive system and breast disorders
post-menopausal bleeding
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Nervous system disorders
presyncope
|
9.1%
4/44 • Number of events 4 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
0.00%
0/44 • 20 weeks
|
4.5%
2/44 • Number of events 2 • 20 weeks
|
|
Infections and infestations
upper respiratory infection
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
2.3%
1/44 • Number of events 2 • 20 weeks
|
|
Renal and urinary disorders
urinary tract infections
|
0.00%
0/44 • 20 weeks
|
4.5%
2/44 • Number of events 2 • 20 weeks
|
|
Gastrointestinal disorders
vomitting
|
4.5%
2/44 • Number of events 2 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Nervous system disorders
dizziness
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/44 • 20 weeks
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
2.3%
1/44 • Number of events 1 • 20 weeks
|
0.00%
0/44 • 20 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place