Effectiveness of phase II cardiac rehabilitation on lower limb function in patients after coronary artery bypass graft (CABG) surgery.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000983505
• Date of registration: 21/09/2015
• Prospective Registration: Yes
• Primary sponsor: Aleksandra Skomudek
• 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.
• Date of first enrolment: 28/09/2015
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12615000983505.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Ms Aleksandra Skomudek

• Name: Ms Aleksandra Skomudek

Key inclusion & exclusion criteria

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.
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.

Age minimum: 50 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Surgery - Other surgery

Physical Medicine / Rehabilitation - Physiotherapy

Cardiovascular - Coronary heart disease

Heart disease ;
Heart disease

Intervention(s)

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.

Primary Outcome(s)

- Venous blood flow in lower limbs assessed by photoplethysmogram;[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).]

- Temperature distribution in lower half of both lower limbs assessed using VarioCam thermal imaging camera;[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).]

- Composite measure of strength of dorsal and plantar flexors assessed by EMG of gastrocnemius and anterior tibial muscles;[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(s)

- Exercise tolerance, assessed by 6MWT.[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).]

- physical activity assessment using IPAQ (International Physical Activity Questionnaire)[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).]

- Quality of life, assessed using SF-36 and WHOQOL-BREF
[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 ID(s)

216787 - National Science Centre

Source(s) of Monetary Support

National Science Centre

Ethics review

Status: Approved
Approval date:
Contact:

Senate Committee Ethics of University School of Physical in Wroclaw