Trial Outcomes & Findings for Effects of Cardiac Rehabilitation (CR) on Functional Capacity and Cardiovascular Risk Factors (NCT NCT02575976)
NCT ID: NCT02575976
Last Updated: 2022-04-28
Results Overview
The Incremental Shuttle Walk Test (ISWT). The ISWT consists of an incremental, walking test where participants are required to walk up and down a 10-meter course. The speed of walking, which is increased by a small increment every minute (0.17 ms-l), is externally paced and controlled by audio signals played from a tape recorder19. There are 12 levels in total, beginning with 0.5 ms-1, and each level lasts for one minute. At the end of each minute, exercise heart rate (HR) and rating of perceived exertion (RPE) scores will be recorded. For this test, the higher the number of meters, the higher the functional capacity.
COMPLETED
NA
115 participants
Functional capacity measured by walked distance in the ISWT at 6 months
2022-04-28
Participant Flow
Participant milestones
| Measure |
Comprehensive CR
education and exercise-based cardiac rehabilitation
comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
|
Exercise-based CR
Exercise-based cardiac rehabilitation
exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions.
|
Wait List Control
no cardiac rehabilitation
wait list control: No cardiac rehabilitation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
39
|
39
|
|
Overall Study
COMPLETED
|
32
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Comprehensive CR
n=37 Participants
education and exercise-based cardiac rehabilitation
comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
|
Exercise-based CR
n=39 Participants
Exercise-based cardiac rehabilitation
exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions.
|
Wait List Control
n=39 Participants
no cardiac rehabilitation
wait list control: No cardiac rehabilitation.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 8.8 • n=37 Participants
|
59.0 years
STANDARD_DEVIATION 9.9 • n=39 Participants
|
58.7 years
STANDARD_DEVIATION 9.6 • n=39 Participants
|
59.5 years
STANDARD_DEVIATION 9.4 • n=115 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=37 Participants
|
11 Participants
n=39 Participants
|
12 Participants
n=39 Participants
|
33 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=37 Participants
|
28 Participants
n=39 Participants
|
27 Participants
n=39 Participants
|
82 Participants
n=115 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Low Education
|
21 Participants
n=37 Participants
|
33 Participants
n=39 Participants
|
28 Participants
n=39 Participants
|
82 Participants
n=115 Participants
|
|
Marital status - Married
|
20 Participants
n=37 Participants
|
27 Participants
n=39 Participants
|
27 Participants
n=39 Participants
|
74 Participants
n=115 Participants
|
|
Work status - employed
|
15 Participants
n=37 Participants
|
14 Participants
n=39 Participants
|
17 Participants
n=39 Participants
|
46 Participants
n=115 Participants
|
|
Low Monthly income
|
31 Participants
n=37 Participants
|
34 Participants
n=39 Participants
|
35 Participants
n=39 Participants
|
100 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Functional capacity measured by walked distance in the ISWT at 6 monthsPopulation: The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers.
The Incremental Shuttle Walk Test (ISWT). The ISWT consists of an incremental, walking test where participants are required to walk up and down a 10-meter course. The speed of walking, which is increased by a small increment every minute (0.17 ms-l), is externally paced and controlled by audio signals played from a tape recorder19. There are 12 levels in total, beginning with 0.5 ms-1, and each level lasts for one minute. At the end of each minute, exercise heart rate (HR) and rating of perceived exertion (RPE) scores will be recorded. For this test, the higher the number of meters, the higher the functional capacity.
Outcome measures
| Measure |
Comprehensive CR
n=26 Participants
education and exercise-based cardiac rehabilitation
comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
|
Exercise-based CR
n=25 Participants
Exercise-based cardiac rehabilitation
exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions.
|
Wait List Control
n=30 Participants
no cardiac rehabilitation
wait list control: No cardiac rehabilitation.
|
|---|---|---|---|
|
Functional Capacity Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test
|
488.1 meters
Standard Deviation 106.3
|
464.8 meters
Standard Deviation 121.6
|
394.0 meters
Standard Deviation 171.9
|
SECONDARY outcome
Timeframe: Systolic blood pressure measured at 6 monthsPopulation: The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers.
Blood pressure was assessed using the validated 7670-06 mobile stand (Welch Allyn Inc., Skaneateles Falls, NY, USA). Mean systolic blood pressure value was recorded, and hypertension was considered where values exceed 140/90 mmHg and/or participant was taking a blood pressure-lowering medication
Outcome measures
| Measure |
Comprehensive CR
n=26 Participants
education and exercise-based cardiac rehabilitation
comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
|
Exercise-based CR
n=25 Participants
Exercise-based cardiac rehabilitation
exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions.
|
Wait List Control
n=30 Participants
no cardiac rehabilitation
wait list control: No cardiac rehabilitation.
|
|---|---|---|---|
|
Risk Factors Measurement of Systolic Blood Pressure
|
114.6 mmHg
Standard Deviation 19.2
|
114.4 mmHg
Standard Deviation 16.3
|
120.0 mmHg
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: Waist circumference measured at 6 monthsPopulation: The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers.
Waist circumference was assessed at the superior border of the iliac crest. Values greater than 102 cm in men and 88 cm in women were considered indicative of central obesity.
Outcome measures
| Measure |
Comprehensive CR
n=25 Participants
education and exercise-based cardiac rehabilitation
comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
|
Exercise-based CR
n=24 Participants
Exercise-based cardiac rehabilitation
exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions.
|
Wait List Control
n=28 Participants
no cardiac rehabilitation
wait list control: No cardiac rehabilitation.
|
|---|---|---|---|
|
Risk Factors Measurement of Waist Circumference.
|
95.5 centimeters
Standard Deviation 13.4
|
93.0 centimeters
Standard Deviation 10.0
|
94.9 centimeters
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Glycaemia measured at 6 monthsPopulation: The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers. Sample size reduced because difficult to obtain the results in a reasonable time frame.
Fasting blood glucose values were extracted from center charts. Dysglycemia was considered present where fasting blood glucose exceeded 126 mg/dl and/or participant was taking a glucose-lowering medication
Outcome measures
| Measure |
Comprehensive CR
n=6 Participants
education and exercise-based cardiac rehabilitation
comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
|
Exercise-based CR
n=5 Participants
Exercise-based cardiac rehabilitation
exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions.
|
Wait List Control
n=6 Participants
no cardiac rehabilitation
wait list control: No cardiac rehabilitation.
|
|---|---|---|---|
|
Risk Factors Measurement of Fasting Blood Glucose Values
|
99.8 mg/dl
Standard Deviation 20.9
|
98.8 mg/dl
Standard Deviation 27.3
|
94.2 mg/dl
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Cholesterol measured at 6 months.Population: The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers. Sample size reduced because difficult to obtain the results in a reasonable time frame.
Total cholesterol values were extracted from center charts and dyslipidemia was considered present where total cholesterol values exceeded 240 mg/dl and/or participant was on a lipid-lowering agent.
Outcome measures
| Measure |
Comprehensive CR
n=7 Participants
education and exercise-based cardiac rehabilitation
comprehensive CR: In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
|
Exercise-based CR
n=7 Participants
Exercise-based cardiac rehabilitation
exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions.
|
Wait List Control
n=7 Participants
no cardiac rehabilitation
wait list control: No cardiac rehabilitation.
|
|---|---|---|---|
|
Risk Factors Measurement of Total Cholesterol Values.
|
150.6 mg/dl
Standard Deviation 25.4
|
169.3 mg/dl
Standard Deviation 51.0
|
153.1 mg/dl
Standard Deviation 29.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 6 months.Assessed by questionnaires.
Outcome measures
Outcome data not reported
Adverse Events
Comprehensive CR
Exercise-based CR
Wait List Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Raquel Britto
Federal University of Minas Gerais
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place