Trial Outcomes & Findings for Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study (NCT NCT00926848)
NCT ID: NCT00926848
Last Updated: 2023-09-25
Results Overview
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
6 months post enrollment/baseline
Results posted on
2023-09-25
Participant Flow
158 couples were assessed for eligibility; 87 couples did not meet inclusion criteria. Of the 72 eligible, 37 declined to participate. Of the 34 couples who consented, 17 couples (17 patients and 17 partners) were randomly allocated to the PaTH group and 17 couples (17 patients and 17 partners) to the usual care group = 68 individual participants.
One patient in the PaTH intervention group did not tolerate the baseline (T1) exercise treadmill test due to orthopedic problems. Thus, this couple was ineligible to continue in the study.
Participant milestones
| Measure |
Usual Care Group
In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
|
PaTH Intervention Group
Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks. These CR components were: prescribed exercise, education about cardiac risk factor modification, and counseling about self-efficacy strategies that may be effective in assisting with initial lifestyle changes and in preventing and managing relapse. All patients and partners in CR will be provided with a comprehensive, individualized, multidisciplinary risk factor modification program focused on all of the person's risk factors for coronary heart disease.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study
Baseline characteristics by cohort
| Measure |
PaTH Intervention Group
n=34 Participants
Patients and partners participated in 18-36 exercise and 18 educational sessions.
|
Usual Care Group
n=34 Participants
Only patients participated in 18-36 exercise and 18 educational sessions. Partners only participated in educational sessions.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post enrollment/baselinePhysical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Outcome measures
| Measure |
PaTH Intervention Group (Patients Only, n=17)
n=17 Participants
Patients in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
|
Usual Care Group (Patients Only, n=17)
n=17 Participants
In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
|
|---|---|---|
|
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients
|
25.8 minutes per day
Standard Deviation 3.3
|
21.8 minutes per day
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: 6 months post enrollment/baselinePhysical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Outcome measures
| Measure |
PaTH Intervention Group (Patients Only, n=17)
n=17 Participants
Patients in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
|
Usual Care Group (Patients Only, n=17)
n=17 Participants
In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
|
|---|---|---|
|
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners
|
45.0 minutes per day
Standard Deviation 4.6
|
38.4 minutes per day
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: 6 months post baselineEating behavior (% saturated fat) was measured using a 3-day food record.
Outcome measures
| Measure |
PaTH Intervention Group (Patients Only, n=17)
n=17 Participants
Patients in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
|
Usual Care Group (Patients Only, n=17)
n=17 Participants
In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
|
|---|---|---|
|
Eating Behavior (% Saturated Fat) in Patients
|
10.0 percent saturated fat per day
Standard Deviation 2.4
|
10.3 percent saturated fat per day
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: 6 months post baselineEating behavior (% saturated fat) was measured using a 3-day food record.
Outcome measures
| Measure |
PaTH Intervention Group (Patients Only, n=17)
n=17 Participants
Patients in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
|
Usual Care Group (Patients Only, n=17)
n=17 Participants
In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
|
|---|---|---|
|
Eating Behavior (% Saturated Fat) in Partners
|
10.6 percent saturated fat per day
Standard Deviation 2.3
|
11.2 percent saturated fat per day
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 6 months post baselineExercise tolerance test using a treadmill
Outcome measures
| Measure |
PaTH Intervention Group (Patients Only, n=17)
n=17 Participants
Patients in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
|
Usual Care Group (Patients Only, n=17)
n=17 Participants
In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
|
|---|---|---|
|
Functional Capacity in Patients
|
9.8 Metabolic equivalents (METs)
Standard Deviation 1.7
|
9.5 Metabolic equivalents (METs)
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 6 months post baselineExercise tolerance test using a treadmill
Outcome measures
| Measure |
PaTH Intervention Group (Patients Only, n=17)
n=17 Participants
Patients in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
|
Usual Care Group (Patients Only, n=17)
n=17 Participants
In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
|
|---|---|---|
|
Functional Capacity in Partners
|
10.3 Metabolic equivalents (METs)
Standard Deviation 1.8
|
9.5 Metabolic equivalents (METs)
Standard Deviation 2.0
|
Adverse Events
PaTH Intervention Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PaTH Intervention Group
n=32 participants at risk
Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks.
|
Usual Care Group
n=32 participants at risk
In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
orthopedic pain
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place