Trial Outcomes & Findings for Physical Activity and Pacemaker Study (NCT NCT03052829)
NCT ID: NCT03052829
Last Updated: 2024-09-19
Results Overview
This is the daily measured active hours in the device
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
6 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Physical Activity Counseling
Subjects will be given counseling on the benefits of increasing activity, instructions on how to slowly increase their activity over 12 weeks with walking, record their daily step counts, and have bi-weekly phone calls with study staff to reinforce the training and help them overcome barriers to being physically active.
Physical activity counseling: Subjects in this arm will receive counseling on how to increase their physical activity level.
|
Patient Usual Care
Subjects will undergo usual care without intervention in this study arm
Usual care: Subjects will undergo their usual care without intervention
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Activity and Pacemaker Study
Baseline characteristics by cohort
| Measure |
Physical Activity Counseling
n=7 Participants
Subjects will be given counseling on the benefits of increasing activity, instructions on how to slowly increase their activity over 12 weeks with walking, record their daily step counts, and have bi-weekly phone calls with study staff to reinforce the training and help them overcome barriers to being physically active.
Physical activity counseling: Subjects in this arm will receive counseling on how to increase their physical activity level.
|
Patient Usual Care
n=6 Participants
Subjects will undergo usual care without intervention in this study arm
Usual care: Subjects will undergo their usual care without intervention
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Continuous
|
84 years
STANDARD_DEVIATION 5 • n=99 Participants
|
75 years
STANDARD_DEVIATION 5 • n=107 Participants
|
80 years
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Body Mass Index
|
30.0 kg/m2
STANDARD_DEVIATION 5.0 • n=99 Participants
|
32.5 kg/m2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
31.2 kg/m2
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
History of Sustained Ventricular Tachycardia
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
History of Non-Sustained Ventricular Tachycardia
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sick Sinus Syndrome
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
High Degree AV Block
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Creatinine Clearance < 60 mL/min/1.73 m2
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Hypertension
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Hyperlipidemia
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Diabetes
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Heart Failure
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Coronary Stent
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Prior CABG
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Prior CVA
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Atrial Fibrillation
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
LVEF%
|
62 %
STANDARD_DEVIATION 3 • n=99 Participants
|
57 %
STANDARD_DEVIATION 4 • n=107 Participants
|
60 %
STANDARD_DEVIATION 4 • n=206 Participants
|
|
LV End Diastolic Dimension
|
43 mm
STANDARD_DEVIATION 3 • n=99 Participants
|
44 mm
STANDARD_DEVIATION 6 • n=107 Participants
|
44 mm
STANDARD_DEVIATION 5 • n=206 Participants
|
|
LV End Systolic Dimension
|
26 mm
STANDARD_DEVIATION 2 • n=99 Participants
|
30 mm
STANDARD_DEVIATION 9 • n=107 Participants
|
28 mm
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Percent Atrial Pacing
|
66 %
STANDARD_DEVIATION 31 • n=99 Participants
|
53 %
STANDARD_DEVIATION 38 • n=107 Participants
|
61 %
STANDARD_DEVIATION 34 • n=206 Participants
|
|
Percent Ventricular Pacing
|
12 %
STANDARD_DEVIATION 21 • n=99 Participants
|
34 %
STANDARD_DEVIATION 51 • n=107 Participants
|
22 %
STANDARD_DEVIATION 38 • n=206 Participants
|
|
Moderate or Greater Mitral Regurgitation
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Current Smoker
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
ACEI or ARB Therapy
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Beta Blocker Therapy
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
HMG CoA Reductase Therapy
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
SBP
|
131 mmHg
STANDARD_DEVIATION 27 • n=99 Participants
|
121 mmHg
STANDARD_DEVIATION 14 • n=107 Participants
|
126 mmHg
STANDARD_DEVIATION 22 • n=206 Participants
|
|
DBP
|
70 mmHg
STANDARD_DEVIATION 9 • n=99 Participants
|
77 mmHg
STANDARD_DEVIATION 18 • n=107 Participants
|
73 mmHg
STANDARD_DEVIATION 14 • n=206 Participants
|
|
HR
|
66 bpm
STANDARD_DEVIATION 4 • n=99 Participants
|
70 bpm
STANDARD_DEVIATION 7 • n=107 Participants
|
68 bpm
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Calculated Gait Speed
|
0.84 m/sec
STANDARD_DEVIATION 0.14 • n=99 Participants
|
0.86 m/sec
STANDARD_DEVIATION 0.18 • n=107 Participants
|
0.85 m/sec
STANDARD_DEVIATION 0.16 • n=206 Participants
|
|
Pacemaker detected active minutes
|
1.59 hours/day
STANDARD_DEVIATION 0.44 • n=99 Participants
|
1.62 hours/day
STANDARD_DEVIATION 0.18 • n=107 Participants
|
1.60 hours/day
STANDARD_DEVIATION 0.33 • n=206 Participants
|
|
Pedometer-Based Daily Step Count
|
2827 steps/day
STANDARD_DEVIATION 1641 • n=99 Participants
|
2474 steps/day
STANDARD_DEVIATION 1623 • n=107 Participants
|
2618 steps/day
STANDARD_DEVIATION 1594 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThis is the daily measured active hours in the device
Outcome measures
| Measure |
Physical Activity Counseling
n=7 Participants
Subjects will be given counseling on the benefits of increasing activity, instructions on how to slowly increase their activity over 12 weeks with walking, record their daily step counts, and have bi-weekly phone calls with study staff to reinforce the training and help them overcome barriers to being physically active.
Physical activity counseling: Subjects in this arm will receive counseling on how to increase their physical activity level.
|
Patient Usual Care
n=6 Participants
Subjects will undergo usual care without intervention in this study arm
Usual care: Subjects will undergo their usual care without intervention
|
|---|---|---|
|
Physical Activity Level as Measured by Embedded Accelerometer
|
1.97 active hours/day
Standard Deviation 0.56
|
1.77 active hours/day
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 6 monthsthis is a daily step count (one week average)
Outcome measures
| Measure |
Physical Activity Counseling
n=7 Participants
Subjects will be given counseling on the benefits of increasing activity, instructions on how to slowly increase their activity over 12 weeks with walking, record their daily step counts, and have bi-weekly phone calls with study staff to reinforce the training and help them overcome barriers to being physically active.
Physical activity counseling: Subjects in this arm will receive counseling on how to increase their physical activity level.
|
Patient Usual Care
n=6 Participants
Subjects will undergo usual care without intervention in this study arm
Usual care: Subjects will undergo their usual care without intervention
|
|---|---|---|
|
Physical Activity Level as Measured by External Pedometer
|
1769 steps/day
Standard Deviation 771
|
2487 steps/day
Standard Deviation 1800
|
Adverse Events
Physical Activity Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place