Trial Outcomes & Findings for Evaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease. (NCT NCT00265525)
NCT ID: NCT00265525
Last Updated: 2026-06-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
223 participants
Primary outcome timeframe
Baseline, 6 and 12 months
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
Cardio Fit
Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website.
|
Usual Care
Participants received activity guidance from their attending cardiologist and an education booklet.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
108
|
|
Overall Study
COMPLETED
|
79
|
74
|
|
Overall Study
NOT COMPLETED
|
36
|
34
|
Reasons for withdrawal
| Measure |
Cardio Fit
Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website.
|
Usual Care
Participants received activity guidance from their attending cardiologist and an education booklet.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
32
|
25
|
|
Overall Study
Health-related
|
4
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cardio Fit
n=115 Participants
Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website.
|
Usual Care
n=108 Participants
Participants received activity guidance from their attending cardiologist and an education booklet.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 Years
STANDARD_DEVIATION 9.0 • n=115 Participants
|
56.0 Years
STANDARD_DEVIATION 9.0 • n=108 Participants
|
56.4 Years
STANDARD_DEVIATION 9.0 • n=223 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=115 Participants
|
15 Participants
n=108 Participants
|
35 Participants
n=223 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=115 Participants
|
93 Participants
n=108 Participants
|
188 Participants
n=223 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Formal Education
|
14.2 Years of Formal Education
STANDARD_DEVIATION 3.2 • n=115 Participants
|
14.4 Years of Formal Education
STANDARD_DEVIATION 3.1 • n=108 Participants
|
14.3 Years of Formal Education
STANDARD_DEVIATION 3.2 • n=223 Participants
|
|
Current smokers
|
13 Participants
n=115 Participants
|
19 Participants
n=108 Participants
|
32 Participants
n=223 Participants
|
|
Body Mass Index
|
28.9 kg/m2
STANDARD_DEVIATION 4.4 • n=115 Participants
|
29.6 kg/m2
STANDARD_DEVIATION 5.2 • n=108 Participants
|
29.3 kg/m2
STANDARD_DEVIATION 4.8 • n=223 Participants
|
|
Diabetic
|
20 Participants
n=115 Participants
|
22 Participants
n=108 Participants
|
42 Participants
n=223 Participants
|
|
Acute Myocardial Infarction this admission
|
34 Participants
n=115 Participants
|
31 Participants
n=108 Participants
|
65 Participants
n=223 Participants
|
|
Percutaneous Coronary Intervention this admission
|
114 Participants
n=115 Participants
|
105 Participants
n=108 Participants
|
219 Participants
n=223 Participants
|
|
Experiencing first cardiac event
|
79 Participants
n=115 Participants
|
65 Participants
n=108 Participants
|
144 Participants
n=223 Participants
|
|
Previous Acute Myocardial Infarction
|
18 Participants
n=115 Participants
|
24 Participants
n=108 Participants
|
42 Participants
n=223 Participants
|
|
Previous Percutaneous Intervention
|
29 Participants
n=115 Participants
|
32 Participants
n=108 Participants
|
61 Participants
n=223 Participants
|
|
Previous Coronary Artery Bypass Grafting
|
10 Participants
n=115 Participants
|
10 Participants
n=108 Participants
|
20 Participants
n=223 Participants
|
|
Pre-hospital physical activity level
|
15.6 Metabolic Equivalent of Tasks (METs)
STANDARD_DEVIATION 21.3 • n=115 Participants
|
14.4 Metabolic Equivalent of Tasks (METs)
STANDARD_DEVIATION 18.1 • n=108 Participants
|
15.0 Metabolic Equivalent of Tasks (METs)
STANDARD_DEVIATION 19.8 • n=223 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 and 12 monthsOutcome measures
| Measure |
Cardio Fit
n=115 Participants
Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website.
|
Usual Care
n=108 Participants
Participants received activity guidance from their attending cardiologist and an education booklet.
|
|---|---|---|
|
Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer
6 months
|
7079 Number of Steps per day over 7 days
Standard Deviation 3159
|
6186 Number of Steps per day over 7 days
Standard Deviation 3159
|
|
Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer
12 months
|
7392 Number of Steps per day over 7 days
Standard Deviation 3365
|
6750 Number of Steps per day over 7 days
Standard Deviation 3366
|
SECONDARY outcome
Timeframe: baseline to 12 monthsOutcome measures
| Measure |
Cardio Fit
n=115 Participants
Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website.
|
Usual Care
n=108 Participants
Participants received activity guidance from their attending cardiologist and an education booklet.
|
|---|---|---|
|
Moderate or Vigorous Physical Activity
6 months
|
201.0 Minutes per week
Standard Deviation 153.2
|
163.4 Minutes per week
Standard Deviation 151.3
|
|
Moderate or Vigorous Physical Activity
12 months
|
201.4 Minutes per week
Standard Deviation 179.8
|
169.6 Minutes per week
Standard Deviation 152.6
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsMeasured at 6months and 12months via MacNew instrument. Each subscale ranges from 1-7 (1 = worse quality of life, 7 = better quality of life), and is reported independently from each of the other subscales.
Outcome measures
| Measure |
Cardio Fit
n=115 Participants
Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website.
|
Usual Care
n=108 Participants
Participants received activity guidance from their attending cardiologist and an education booklet.
|
|---|---|---|
|
Heart Disease Health-related Quality of Life
Emotional subscale - 6 months
|
5.5 Scores on a scale
Standard Deviation 0.7
|
5.4 Scores on a scale
Standard Deviation 0.8
|
|
Heart Disease Health-related Quality of Life
Emotional subscale - 12 months
|
5.6 Scores on a scale
Standard Deviation 0.6
|
5.4 Scores on a scale
Standard Deviation 0.7
|
|
Heart Disease Health-related Quality of Life
Social subscale - 6 months
|
6.2 Scores on a scale
Standard Deviation 0.8
|
6.1 Scores on a scale
Standard Deviation 1.0
|
|
Heart Disease Health-related Quality of Life
Global Score - 6 months
|
5.8 Scores on a scale
Standard Deviation 0.7
|
5.7 Scores on a scale
Standard Deviation 0.8
|
|
Heart Disease Health-related Quality of Life
Global Score - 12 months
|
5.8 Scores on a scale
Standard Deviation 0.6
|
2.6 Scores on a scale
Standard Deviation 0.8
|
|
Heart Disease Health-related Quality of Life
Social subscale - 12 months
|
6.3 Scores on a scale
Standard Deviation 0.8
|
6.0 Scores on a scale
Standard Deviation 1.0
|
|
Heart Disease Health-related Quality of Life
Physical subscale - 6 months
|
5.9 Scores on a scale
Standard Deviation 0.9
|
5.7 Scores on a scale
Standard Deviation 1.1
|
|
Heart Disease Health-related Quality of Life
Physical subscale - 12 months
|
6.0 Scores on a scale
Standard Deviation 0.8
|
5.8 Scores on a scale
Standard Deviation 1.0
|
Adverse Events
Cardio Fit
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 7 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cardio Fit
n=115 participants at risk
Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website.
|
Usual Care
n=108 participants at risk
Participants received activity guidance from their attending cardiologist and an education booklet.
|
|---|---|---|
|
Cardiac disorders
Hospitalization for chest pain
|
3.5%
4/115 • Baseline to 12 months
|
5.6%
6/108 • Baseline to 12 months
|
|
Cardiac disorders
Coronary Artery Bypass Grafting
|
0.00%
0/115 • Baseline to 12 months
|
0.93%
1/108 • Baseline to 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place