Trial Outcomes & Findings for Technological Platforms and Telerehabilitation in Heart Surgery (NCT NCT02653326)
NCT ID: NCT02653326
Last Updated: 2019-01-28
Results Overview
Ergospirometric assessment of oxygen consumption (VO2) among study participants.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
4 weeks after randomisation
Results posted on
2019-01-28
Participant Flow
Participant milestones
| Measure |
Telerehabilitation
In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.
Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
|
Routine Care
Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:
Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
22
|
27
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Telerehabilitation
In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.
Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
|
Routine Care
Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:
Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
Baseline Characteristics
Technological Platforms and Telerehabilitation in Heart Surgery
Baseline characteristics by cohort
| Measure |
Telerehabilitation
n=32 Participants
In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.
Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
|
Routine Care
n=34 Participants
Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:
Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
60.9 years
STANDARD_DEVIATION 17.1 • n=107 Participants
|
61.4 years
STANDARD_DEVIATION 14.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Body mass index
|
28.2 kg/m^2
STANDARD_DEVIATION 3.1 • n=99 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 3.4 • n=107 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 3.3 • n=206 Participants
|
|
Smoker
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Diabetes mellitus
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Dyslipidemia
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Hypertension
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sleep apnea
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Peripheral vascular disease
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Alcoholism
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Cancer
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Chronic obstructive lung disease
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Heart rate at rest
|
80.9 beats per minute
STANDARD_DEVIATION 13.2 • n=99 Participants
|
83.0 beats per minute
STANDARD_DEVIATION 13.6 • n=107 Participants
|
81.9 beats per minute
STANDARD_DEVIATION 13.3 • n=206 Participants
|
|
Heart rate at anaerobic threshold
|
117.1 beats per minute
STANDARD_DEVIATION 21.8 • n=99 Participants
|
116.4 beats per minute
STANDARD_DEVIATION 18.1 • n=107 Participants
|
116.7 beats per minute
STANDARD_DEVIATION 19.8 • n=206 Participants
|
|
Heart rate during maximum intensity exercises
|
127.0 beats per minute
STANDARD_DEVIATION 23.8 • n=99 Participants
|
126 beats per minute
STANDARD_DEVIATION 22.0 • n=107 Participants
|
126.4 beats per minute
STANDARD_DEVIATION 22.7 • n=206 Participants
|
|
Mechanic load at anaerobic threshold
|
62.6 watts
STANDARD_DEVIATION 23.2 • n=99 Participants
|
65.5 watts
STANDARD_DEVIATION 29.6 • n=107 Participants
|
64.1 watts
STANDARD_DEVIATION 26.4 • n=206 Participants
|
|
Mechanic load during maximum intensity exercises
|
80.6 watts
STANDARD_DEVIATION 48 • n=99 Participants
|
81.1 watts
STANDARD_DEVIATION 34.2 • n=107 Participants
|
80.9 watts
STANDARD_DEVIATION 41.4 • n=206 Participants
|
|
Oxygen consumption at rest
|
0.23 mL/Kg/minute
STANDARD_DEVIATION 0.82 • n=99 Participants
|
0.24 mL/Kg/minute
STANDARD_DEVIATION 0.80 • n=107 Participants
|
0.23 mL/Kg/minute
STANDARD_DEVIATION 0.8 • n=206 Participants
|
|
Oxygen consumption during training
|
0.84 mL/Kg/minute
STANDARD_DEVIATION 0.36 • n=99 Participants
|
0.78 mL/Kg/minute
STANDARD_DEVIATION 0.25 • n=107 Participants
|
0.81 mL/Kg/minute
STANDARD_DEVIATION 0.30 • n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after randomisationPopulation: Ergospirometric evaluations were conducted after the initial physiotherapy phase was completed amongst study participants.
Ergospirometric assessment of oxygen consumption (VO2) among study participants.
Outcome measures
| Measure |
Telerehabilitation
n=32 Participants
In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.
Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
|
Routine Care
n=34 Participants
Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:
Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
|
|---|---|---|
|
Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation
|
0.92 mL/Kg/minute
Standard Deviation 0.39
|
0.87 mL/Kg/minute
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: 8 weeks after randomisationPopulation: Outcome assessment after telerehabilitation phase was completed. These are complete-case analyses only. Results using multiple imputation techniques for missing data are given below.
Exercise Capacity Assessed as Peak Oxygen Consumption at 8 weeks after randomisation
Outcome measures
| Measure |
Telerehabilitation
n=22 Participants
In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.
Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
|
Routine Care
n=27 Participants
Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:
Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
|
|---|---|---|
|
Exercise Capacity
|
1.0 mL/Kg/minute
Standard Deviation 0.4
|
0.91 mL/Kg/minute
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 4 weeks after randomisationDevelopment of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias.
Outcome measures
| Measure |
Telerehabilitation
n=32 Participants
In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.
Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
|
Routine Care
n=34 Participants
Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:
Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
|
|---|---|---|
|
Number of Participants With Adverse Events at 4 Weeks
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeks after randomisationDevelopment of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias.
Outcome measures
| Measure |
Telerehabilitation
n=22 Participants
In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.
Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
|
Routine Care
n=27 Participants
Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:
Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
|
|---|---|---|
|
Number of Participants With Adverse Events at 8 Weeks
|
0 Participants
|
0 Participants
|
Adverse Events
Telerehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine 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