Trial Outcomes & Findings for Exercise Intolerance in Elderly Patients With Diastolic Heart Failure (NCT NCT00959660)
NCT ID: NCT00959660
Last Updated: 2019-02-15
Results Overview
Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
20 weeks
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Exercise Training
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Exercise: walking, treadmill and bicycle exercise
|
Dietary Intervention
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.
Dietary Intervention: Subjects will be provided meals and instructions for individual food selections.
|
Attention Control
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Attention Control: control group- continue their previously randomized life style
|
Diet and Exercise
The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Intolerance in Elderly Patients With Diastolic Heart Failure
Baseline characteristics by cohort
| Measure |
Exercise Training
n=26 Participants
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Exercise: walking, treadmill and bicycle exercise
|
Dietary Intervention
n=24 Participants
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.
Dietary Intervention: Subjects will be provided meals and instructions for individual food selections.
|
Attention Control
n=25 Participants
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Attention Control: control group- continue their previously randomized life style
|
Diet and Exercise
n=25 Participants
The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
65.6 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
66.5 years
STANDARD_DEVIATION 5.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 20 weeksExercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.
Outcome measures
| Measure |
Exercise Training
n=24 Participants
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Exercise: walking, treadmill and bicycle exercise
|
Dietary Intervention
n=24 Participants
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.
Dietary Intervention: Subjects will be provided meals and instructions for individual food selections.
|
Attention Control
n=22 Participants
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Attention Control: control group- continue their previously randomized life style
|
Diet and Exercise
n=22 Participants
The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described.
|
|---|---|---|---|---|
|
Exercise Capacity
|
15.5 ml/kg/min
Interval 15.1 to 15.9
|
15.5 ml/kg/min
Interval 15.1 to 15.9
|
14.1 ml/kg/min
Interval 13.5 to 14.7
|
16.6 ml/kg/min
Interval 16.0 to 17.2
|
SECONDARY outcome
Timeframe: 20 weeksHeart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life.
Outcome measures
| Measure |
Exercise Training
n=24 Participants
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Exercise: walking, treadmill and bicycle exercise
|
Dietary Intervention
n=24 Participants
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.
Dietary Intervention: Subjects will be provided meals and instructions for individual food selections.
|
Attention Control
n=22 Participants
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Attention Control: control group- continue their previously randomized life style
|
Diet and Exercise
n=22 Participants
The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described.
|
|---|---|---|---|---|
|
Quality of Life
|
71 units on a scale
Interval 67.0 to 75.0
|
77 units on a scale
Interval 73.0 to 81.0
|
69 units on a scale
Interval 63.0 to 75.0
|
79 units on a scale
Interval 75.0 to 84.0
|
SECONDARY outcome
Timeframe: 20 weeksTotal Body Fat Mass and Total Non-bone Lean Mass via DEXA
Outcome measures
| Measure |
Exercise Training
n=24 Participants
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Exercise: walking, treadmill and bicycle exercise
|
Dietary Intervention
n=24 Participants
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.
Dietary Intervention: Subjects will be provided meals and instructions for individual food selections.
|
Attention Control
n=22 Participants
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Attention Control: control group- continue their previously randomized life style
|
Diet and Exercise
n=22 Participants
The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described.
|
|---|---|---|---|---|
|
Body Composition
Total Fat
|
45 kg
Interval 43.0 to 47.0
|
42 kg
Interval 40.0 to 44.0
|
47 kg
Interval 45.0 to 49.0
|
40 kg
Interval 38.0 to 42.0
|
|
Body Composition
Total Non-Bone Lean
|
52 kg
Interval 50.0 to 54.0
|
50 kg
Interval 50.0 to 50.0
|
53 kg
Interval 53.0 to 53.0
|
50 kg
Interval 48.0 to 52.0
|
SECONDARY outcome
Timeframe: 20 weeksThigh Skeletal Muscle and Subcutaneous Fat via MRI
Outcome measures
| Measure |
Exercise Training
n=24 Participants
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Exercise: walking, treadmill and bicycle exercise
|
Dietary Intervention
n=24 Participants
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.
Dietary Intervention: Subjects will be provided meals and instructions for individual food selections.
|
Attention Control
n=22 Participants
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Attention Control: control group- continue their previously randomized life style
|
Diet and Exercise
n=22 Participants
The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described.
|
|---|---|---|---|---|
|
Thigh Muscle Composition
Thigh Subcutaneous Fat
|
155 cm^2
Interval 149.0 to 161.0
|
143 cm^2
Interval 137.0 to 149.0
|
164 cm^2
Interval 158.0 to 170.0
|
144 cm^2
Interval 138.0 to 150.0
|
|
Thigh Muscle Composition
Thigh Skeletal Muscle
|
120 cm^2
Interval 118.0 to 122.0
|
115 cm^2
Interval 113.0 to 117.0
|
121 cm^2
Interval 117.0 to 125.0
|
114 cm^2
Interval 112.0 to 116.0
|
Adverse Events
Exercise Training
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Dietary Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Attention Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Diet and Exercise
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise Training
n=26 participants at risk
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Exercise: walking, treadmill and bicycle exercise
|
Dietary Intervention
n=24 participants at risk
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.
Dietary Intervention: Subjects will be provided meals and instructions for individual food selections.
|
Attention Control
n=25 participants at risk
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Attention Control: control group- continue their previously randomized life style
|
Diet and Exercise
n=25 participants at risk
The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described.
|
|---|---|---|---|---|
|
Cardiac disorders
Heart failure exacerbation
|
0.00%
0/26 • 20 weeks
|
0.00%
0/24 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
4.0%
1/25 • Number of events 3 • 20 weeks
|
|
Endocrine disorders
Pancreatitis
|
3.8%
1/26 • Number of events 1 • 20 weeks
|
0.00%
0/24 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
|
Blood and lymphatic system disorders
Leg edema
|
0.00%
0/26 • 20 weeks
|
0.00%
0/24 • 20 weeks
|
4.0%
1/25 • Number of events 2 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
Other adverse events
| Measure |
Exercise Training
n=26 participants at risk
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Exercise: walking, treadmill and bicycle exercise
|
Dietary Intervention
n=24 participants at risk
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.
Dietary Intervention: Subjects will be provided meals and instructions for individual food selections.
|
Attention Control
n=25 participants at risk
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Attention Control: control group- continue their previously randomized life style
|
Diet and Exercise
n=25 participants at risk
The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described.
|
|---|---|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/26 • 20 weeks
|
4.2%
1/24 • Number of events 1 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
4.0%
1/25 • Number of events 1 • 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • 20 weeks
|
0.00%
0/24 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Stress fracture
|
3.8%
1/26 • Number of events 1 • 20 weeks
|
0.00%
0/24 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendon tear
|
0.00%
0/26 • 20 weeks
|
0.00%
0/24 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
4.0%
1/25 • 20 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place