Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000983505
Ethics application status
Approved
Date submitted
11/05/2015
Date registered
21/09/2015
Date last updated
21/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of phase II cardiac rehabilitation on lower limb function in patients after coronary artery bypass graft (CABG) surgery.
Scientific title
Effectiveness of phase II cardiac rehabilitation on lower limb function in patients after coronary artery bypass graft (CABG) surgery with collection of saphenous vein.
Secondary ID [1] 284811 0
216787 - National Science Centre
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 292194 0
Condition category
Condition code
Cardiovascular 292529 292529 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 292530 292530 0 0
Physiotherapy
Surgery 295645 295645 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be qualified to Phase II cardiac rehabilitation in accordance with the standards of cardiac rehabilitation which is up to 4 weeks after CABG surgery on the basis of an exercise test using the modified Bruce protocol. Participants will be randomised to two groups. One group will take part in the early hospital rehabilitation (3 weeks - this is the overall duration of the program), while the second group will take part in ambulatory rehabilitation (8 weeks).

For the group of patients undergoing 3-week early hospital rehabilitation, rehabilitation sessions will be carried out five times a week.

Cardiac rehabilitation is composed of:
a) aerobic exercise on a stationary cycle ergometer 3-5day/week, 30 minutes
b) resistance training - 3 days/week, 3 session, 6 different exercises, 15 repetitions at 70% HR, 25 minutes for session
c) general development exercises (exercise to increase physical performance) - 5 days/week, 20 different exercises, the intensity selected in accordance with the result of exercise testing (exercises for the upper limbs, lower limbs, breathing exercises), 30 minutes.

Physical activity will be carried out in the form of training on cycle ergometer each time to achieve the patient's submaximal heart rate (submaximal heart rate is 85% of maximum heart rate. Maximum heart is calculated using the formula: 220 - age).

Exercises take place in a group carried by a physiotherapist.
Intervention code [1] 289601 0
Rehabilitation
Intervention code [2] 292139 0
Treatment: Other
Comparator / control treatment
The second group will take part in ambulatory rehabilitation (8 weeks).

While in the group of patients undergoing 8-weeks ambulatory rehabilitation, rehabilitation sessions will be carried out 3 times a week.

Cardiac rehabilitation is composed of:
a) aerobic exercise on a stationary cycle ergometer 3 /week, 30 minutes
b) resistance training - 3 days/week, 3 sesion, 6 different exercises, 12-15 repetitions at 70% HR, 25 minutes for session
c) general development exercises (exercise to increase physical performance) - 3 days/week, 20 different exercises, the intensity selected in accordance with the result of exercise testing (exercises for the upper limbs, lower limbs, breathing exercises), 30 minutes.

Physical activity will be carried out in the form of training on cycle ergometer each time to achieve the patient's submaximal heart rate (submaximal heart rate is 85% of maximum heart rate. Maximum heart is calculated using the formula: 220 - age).

Exercises take place in a group carried by a physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 292392 0
- Temperature distribution in lower half of both lower limbs assessed using VarioCam thermal imaging camera;
Timepoint [1] 292392 0
1. measurement - one day before surgery (for I group),
2. measurement - after surgery (21 days) and simultaneously before the start of the Phase II of cardiac rehabilitation (one day before the start of the Phase II of cardiac rehabilitation - for I and II group)
3. measurement – after completing Phase II of cardiac rehabilitation – for Group I after 3 weeks (after 21 days), for Group II after 8 weeks of cardiac rehabilitation (on the last day rehabilitation).
Primary outcome [2] 295864 0
- Venous blood flow in lower limbs assessed by photoplethysmogram;
Timepoint [2] 295864 0
1. measurement - one day before surgery (for I group),
2. measurement - after surgery (21 days) and simultaneously before the start of the Phase II of cardiac rehabilitation (one day before the start of the Phase II of cardiac rehabilitation - for I and II group)
3. measurement – after completing Phase II of cardiac rehabilitation – for Group I after 3 weeks (after 21 days), for Group II after 8 weeks of cardiac rehabilitation (on the last day rehabilitation).
Primary outcome [3] 295865 0
- Composite measure of strength of dorsal and plantar flexors assessed by EMG of gastrocnemius and anterior tibial muscles;
Timepoint [3] 295865 0
1. measurement - one day before surgery (for I group),
2. measurement - after surgery (21 days) and simultaneously before the start of the Phase II of cardiac rehabilitation (one day before the start of the Phase II of cardiac rehabilitation - for I and II group)
3. measurement – after completing Phase II of cardiac rehabilitation – for Group I after 3 weeks (after 21 days), for Group II after 8 weeks of cardiac rehabilitation (on the last day rehabilitation).
Secondary outcome [1] 308861 0
- physical activity assessment using IPAQ (International Physical Activity Questionnaire)
Timepoint [1] 308861 0
All tests will be carried out:
1. measurement - one day before surgery (for Group I),
2. measurement – after completing Phase II of cardiac rehabilitation – for Group I after 3 weeks (after 21 days).
Secondary outcome [2] 316752 0
- Quality of life, assessed using SF-36 and WHOQOL-BREF
Timepoint [2] 316752 0
All tests will be carried out:
1. measurement - one day before surgery (for Group I),
2. measurement – after completing Phase II of cardiac rehabilitation – for Group I after 3 weeks (after 21 days).
Secondary outcome [3] 316753 0
- Exercise tolerance, assessed by 6MWT.
Timepoint [3] 316753 0
1. measurement - one day before surgery (for I group),
2. measurement - after surgery (21 days) and simultaneously before the start of the Phase II of cardiac rehabilitation (one day before the start of the Phase II of cardiac rehabilitation - for I and II group)
3. measurement – after completing Phase II of cardiac rehabilitation – for Group I after 3 weeks (after 21 days), for Group II after 8 weeks of cardiac rehabilitation (on the last day rehabilitation).

Eligibility
Key inclusion criteria
1. eligible participants must have coronary heart disease and must have been scheduled to undergo CABG surgery
2. Participants written consent,
3. Age between 50-70 years,
4. Stable condition, without periods of exacerbations occurring during the 4 weeks from the surgery, before the start of the rehabilitation program,
5. Patients will be qualified to Phase II cardiac rehabilitation in accordance with the standards of cardiac rehabilitation which is up to 4 weeks after CABG surgery on the basis of an exercise test using the modified Bruce protocol
6. Not participating in rehabilitation programs within a year of the start of the study.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unstable angina,
2. Kidney failure,
3. Liver failure,
4. Inflammation,
5. Skin conditions in the assessment point,
6. Acute bronchitis, pneumonia, tuberculosis,
7. Asthma,
8. Uncontrolled high blood pressure (hypertension triggers and accelerates the formation of atherosclerotic in the coronary
arteries as well as coronary bypasses,
9. Mental handicap preventing cooperation,
10. Orthopaedic and neurological conditions, which reduce the efficiency of the motor function and the ability of the patient
to cooperate during the scheduled training,
11. Mental disorder preventing cooperation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The minimum number of patients for analysis participants needed to achieve study objectives was determined for 60 (30 patients for I group and 30 patients for II group).
The I Group - 30 patients with coronary heart disease in whom measurements will be performed before and after saphenous vein autograft CABG surgery and after 3 weeks of cardiac rehabilitation (Phase II early hospital).
The II Group - In those 30 patients tests will be carried out before and after 8 weeks of Phase II ambulatory cardiac rehabilitation. Test results will be compiled in an Excel spreadsheet, and then subjected to statistical analysis using STATISTICA PL. The basic descriptive characteristics measurable characteristics will be calculated the arithmetic mean, standard deviation, minimum and maximum value and the median of the upper and lower quartiles.
After checking the normality of the Shapiro-Wilk test, it will be decided on the type of statistical tests used:
* In the absence of evidence to reject the hypothesis of normal distribution is performed univariate analysis of variance with repeated measures and post-hoc test (NIR)
* rejecting the hypothesis of normal distribution effect of cardiac rehabilitation conducted (training) will be assessed Friedman ANOVA for significant relationships between the terms of the following will be used in post hoc test Friedman
* to demonstrate the connection will be used Pearson correlations simple or rank Spaermana (for the characteristics of the distribution is different from the normal).

The statistical tests used to the test values and the coefficients for the level of p <0.05 will be accepted as statistically significant.
The calculation of sample size were not performed. It was assumed that 30 participants is required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/09/2015
Actual
Date of last participant enrolment
Anticipated
21/03/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6153 0
Poland
State/province [1] 6153 0
Wroclaw

Funding & Sponsors
Funding source category [1] 291031 0
Government body
Name [1] 291031 0
National Science Centre
Country [1] 291031 0
Poland
Primary sponsor type
Individual
Name
Aleksandra Skomudek
Address
The Opole University of Technology 76 Proszkowska Street, 45-758 Opole
Country
Poland
Secondary sponsor category [1] 289712 0
None
Name [1] 289712 0
Address [1] 289712 0
Country [1] 289712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291183 0
Senate Committee Ethics of University School of Physical in Wroclaw
Ethics committee address [1] 291183 0
Ethics committee country [1] 291183 0
Poland
Date submitted for ethics approval [1] 291183 0
Approval date [1] 291183 0
27/05/2013
Ethics approval number [1] 291183 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49238 0
Ms Aleksandra Skomudek
Address 49238 0
The Opole University of Technology 76 Proszkowska Street, 45-758 Opole
Country 49238 0
Poland
Phone 49238 0
+48 663 266 278
Fax 49238 0
Email 49238 0
[email protected]
Contact person for public queries
Name 49239 0
Aleksandra Skomudek
Address 49239 0
The Opole University of Technology 76 Proszkowska Street, 45-758 Opole
Country 49239 0
Poland
Phone 49239 0
+48 663 266 278
Fax 49239 0
Email 49239 0
[email protected]
Contact person for scientific queries
Name 49240 0
Aleksandra Skomudek
Address 49240 0
The Opole University of Technology 76 Proszkowska Street, 45-758 Opole
Country 49240 0
Poland
Phone 49240 0
+48 663 266 278
Fax 49240 0
Email 49240 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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