Trial Outcomes & Findings for Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation (NCT NCT01732419)
NCT ID: NCT01732419
Last Updated: 2019-08-29
Results Overview
Changes in peak oxygen uptake (VO2max) in mL O2/kg/min
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Measured after 12 weeks and after one year
Results posted on
2019-08-29
Participant Flow
Participant milestones
| Measure |
Home-based Training
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Home-based training: Home-based exercise training for cardiac patients.
|
Centre-based Training
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
Centre-based training: Usual exercise training in an outpatient setting.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
37
|
41
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
Baseline characteristics by cohort
| Measure |
Home-based Training
n=45 Participants
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Home-based training: Home-based exercise training for cardiac patients.
|
Centre-based Training
n=45 Participants
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
Centre-based training: Usual exercise training in an outpatient setting.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured after 12 weeks and after one yearPopulation: patients finished the study
Changes in peak oxygen uptake (VO2max) in mL O2/kg/min
Outcome measures
| Measure |
Home-based Training
n=37 Participants
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Home-based training: Home-based exercise training for cardiac patients.
|
Centre-based Training
n=41 Participants
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
Centre-based training: Usual exercise training in an outpatient setting.
|
|---|---|---|
|
Physical Fitness
Baseline
|
24.4 ml O2/kg/min
Standard Deviation 6.7
|
24.0 ml O2/kg/min
Standard Deviation 5.6
|
|
Physical Fitness
Discharge CR (12 weeks)
|
27.9 ml O2/kg/min
Standard Deviation 7.5
|
26.5 ml O2/kg/min
Standard Deviation 7.1
|
|
Physical Fitness
Follow up (1 year)
|
27.7 ml O2/kg/min
Standard Deviation 6.9
|
27.5 ml O2/kg/min
Standard Deviation 8.1
|
PRIMARY outcome
Timeframe: measured after 12 weeks and after one yearPopulation: Patients finished the study
PAL is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously. To determine PAL, physical activity energy expenditure is divided by resting metabolic rate, calculated by the Harris-Benedict equation. PAL expressed a person's daily energy expenditure. When PAL is used to classify the intensity of an activity, PAL\<3, PAL\<6 and PAL\>6 are characterized as light, moderate and vigorous intensity activities respectively. An average daily PAL of 1.2 represents the activity level of a bed-bound subject, while the average PAL for the adult population is 1.7.
Outcome measures
| Measure |
Home-based Training
n=37 Participants
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Home-based training: Home-based exercise training for cardiac patients.
|
Centre-based Training
n=41 Participants
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
Centre-based training: Usual exercise training in an outpatient setting.
|
|---|---|---|
|
Physical Activity Level (PAL)
Follow up (1 year)
|
2.14 PAL
Standard Deviation 1.06
|
2.13 PAL
Standard Deviation 1
|
|
Physical Activity Level (PAL)
Baseline
|
2.09 PAL
Standard Deviation 0.92
|
1.95 PAL
Standard Deviation 0.86
|
|
Physical Activity Level (PAL)
Discharge CR (12 weeks)
|
2.22 PAL
Standard Deviation 0.99
|
2.38 PAL
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients finished the CR program
Provides information on the average amount of training sessions were performed during the 12 week cardiac rehabilitation program. Both groups received the advice to train at least 2 times a week for 12 weeks (thus 24 sessions).
Outcome measures
| Measure |
Home-based Training
n=40 Participants
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Home-based training: Home-based exercise training for cardiac patients.
|
Centre-based Training
n=37 Participants
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
Centre-based training: Usual exercise training in an outpatient setting.
|
|---|---|---|
|
Training Adherence
|
22.0 Exercise sessions completed
Standard Deviation 6.8
|
20.6 Exercise sessions completed
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: measured at baseline, at discharge (12 weeks), and follow-up (one year)Population: Patients finished the study
Health-related quality of life will be assessed by the MacNew questionnaire. The items and scale are scored from 1 (low health-related Quality of Life) to 7 (High health-related Quality of Life).
Outcome measures
| Measure |
Home-based Training
n=37 Participants
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Home-based training: Home-based exercise training for cardiac patients.
|
Centre-based Training
n=41 Participants
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
Centre-based training: Usual exercise training in an outpatient setting.
|
|---|---|---|
|
Health Related Quality of Life
Discharge CR (12 weeks)
|
6.00 Units of a scale
Standard Deviation 0.13
|
5.90 Units of a scale
Standard Deviation 0.13
|
|
Health Related Quality of Life
Baseline
|
5.62 Units of a scale
Standard Deviation 0.20
|
5.45 Units of a scale
Standard Deviation 0.14
|
|
Health Related Quality of Life
Follow up (one year)
|
5.75 Units of a scale
Standard Deviation 0.10
|
5.43 Units of a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Measured at CR discharge (12 weeks)Population: Patients finished the CR program (12 weeks)
Patient satisfaction is measured directly after CR discharge (12 weeks) using the Consumer Quality Index, a standardized survey method combining the inventory of patient experiences with an assessment of their priority. Results are provided on a scale of 1 (very low satisfaction) to 10 (very high satisfaction).
Outcome measures
| Measure |
Home-based Training
n=40 Participants
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Home-based training: Home-based exercise training for cardiac patients.
|
Centre-based Training
n=43 Participants
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
Centre-based training: Usual exercise training in an outpatient setting.
|
|---|---|---|
|
Patient Satisfaction
|
8.7 units on a scale
Standard Deviation 1.0
|
8.1 units on a scale
Standard Deviation 1.2
|
Adverse Events
Home-based Training
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Centre-based Training
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home-based Training
n=45 participants at risk
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate.
Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Home-based training: Home-based exercise training for cardiac patients.
|
Centre-based Training
n=45 participants at risk
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
Centre-based training: Usual exercise training in an outpatient setting.
|
|---|---|---|
|
Vascular disorders
Death
|
2.2%
1/45 • Number of events 1 • During the study period (1 year)
The definition of adverse events did not differ from the clinicaltrials.gov definition.
|
0.00%
0/45 • During the study period (1 year)
The definition of adverse events did not differ from the clinicaltrials.gov definition.
|
|
Cardiac disorders
Heart attack
|
0.00%
0/45 • During the study period (1 year)
The definition of adverse events did not differ from the clinicaltrials.gov definition.
|
2.2%
1/45 • Number of events 1 • During the study period (1 year)
The definition of adverse events did not differ from the clinicaltrials.gov definition.
|
|
Cardiac disorders
Rehospitalization due to cardiac reasons
|
4.4%
2/45 • Number of events 2 • During the study period (1 year)
The definition of adverse events did not differ from the clinicaltrials.gov definition.
|
17.8%
8/45 • Number of events 8 • During the study period (1 year)
The definition of adverse events did not differ from the clinicaltrials.gov definition.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place