The experimental group undergoes the same intervention as described above for the control group. In addition, the experimental intervention consists of a physical exercise training component and a psycho-educational component.
The physical exercise component
The CopenHeart intervention has been developed and partly tested in a clinical rehabilitation trial, the COPE-ICD trial [
47], including patients with implantable cardioverter defibrillator. We observed a significant impact of the intervention on peak VO
2, physical capacity and self-assessed mental health. The intervention has been modified for patients with heart valve surgery as described below.
The CopenHeart physical exercise intervention meets European [
48] and Danish guidelines [
49] for physical exercise in patients with heart disease, and complies with The National Danish Board of Health recommendations for physical exercise in daily living for heart patients [
50].
The physical exercise starts 1 month post surgery after the first cardiopulmonary exercise testing, and comprises the following three elements:
Individual planning of the physical exercise. A specially trained physiotherapist conducts a patient consultation of up to 30 min, integrating detailed information concerning the specific heart valve disease, co-morbidity, hospitalisation, activities of daily living, level of physical activity prior to heart valve surgery, and results from initial testing including cardiopulmonary exercise test 1 month post surgery, a 6-minute walk test, and a ‘sit and stand’ test. The level of physical activity prior to heart valve surgery is also monitored by a self-assessed questionnaire [
51]. For all patients, a rehabilitation plan is prepared as an individual training diary based on results from the cardiopulmonary exercise test 1 month post surgery, and the patients are instructed in the use of a heart rate monitor (Polar Watch). The exercise diary and the heart rate monitor recordings are essential in monitoring and in assuring adherence to the intervention. At the end of the intervention the diary and the heart rate monitor are returned and compliance and intensity level are coded independently.
Intensive physical exercise regimen. Physical exercise is initiated at a physiotherapist supervised setting at the Heart Centre, Rigshospitalet, 4 weeks after surgery to ensure optimal healing and decrease the risk of unstable sternum. Using wireless electrodes integrated into t-shirts (Corus-Fit, CardioCardio and Corus Exercise Assistant, version 2.0.16, Finland) potential cardiac arrhythmias, electrocardiographic abnormalities such as ST segment changes, T-wave alterations, atrial or ventricular arrhythmias, and training intensity level are monitored. The training is initiated with one to three mandatory exercise sessions in the primary investigating hospital, Rigshospitalet. Subsequently, the patients can choose to continue the intensive physical exercise regimen either in hospital at Rigshospitalet, at a local CopenHeart-certified facility, supervised by physiotherapists, or as supervised home-based training. Supervised home-based physical training has previously shown similar results to hospital-based training [
52]. This finding has been confirmed in a Danish setting [
53]. An exercise bicycle at home is required for the patient to perform home-based exercise training.
The training programme continues for 12 weeks, comprising three sessions weekly of 60 min, 36 sessions in total. The training protocol consists of cardiovascular training and strength exercises due to the fact that decreased exercise intolerance in heart valve patients has been suggested to depend on decreased muscular strength [
54].
One session consists of 10 min warm-up bicycling, 20 min bicycling with increased intensity (cardiovascular training), 20 min strength exercises, and 10 min stretching and cool-down period. The warm-up session is performed at the intensity of 11–12 on the Borg scale [
55]. The 20-min cardiovascular training is performed as interval training. Each session is divided into three sections. Each section contains intensity 13–17 on the Borg scale and time limit (2–15 min) varying between each section; the second section with longest and highest intensity. A cool down period of 5 min is included after the 20 min of cardiovascular training.
The strength and strength-related exercises primarily target lower body muscles, and comprise the following four exercises: (1) Heel rise performed by repetitions of maximal flexion from standing position; (2) Step-up by using a step bench of 27 cm; (3) Leg press standardised, starting with 90 degrees flexion, hyperextension not accepted; (4) 90 degrees pull-down performed in a cable machine to target abdominal muscles. For step-ups and heel-rises, weight load is calculated as a percentage of body weight (5-20%) and increased throughout the 12 weeks. Load for leg press is estimated from repetition maximum (RM) testing and increases from 60% of 1 RM to 70% of 1 RM during the 12 weeks of training. Load for 90 degree pull-downs is decided individually by the physiotherapist assessed from the stabilisation of truncus. All exercises are initiated by 2x12 repetitions and increased through the program according to standard guidelines for strength training [
56]. For home-based training two exercises are modified (leg press and abdominal crunch).
Due to the fact of patients having had a sternotomy, upper body strength training is not initiated before the patient is pain free and at least 6 weeks post surgery to avoid complications such as unstable sternum. To achieve cardiovascular adjustment and reduce risk of malignant cardiac arrhythmias, the training sessions are initiated and terminated with a warm-up and cool-down period, with a gradual decrease in training intensity. Training is mainly performed in the upright position to reduce left ventricle preload (diastolic volume).
Sustained moderate physical exercise daily. Patients are guided individually to continue sustained moderate physical exercise daily, and are instructed in maintaining daily moderate physical exercise for at least 30 min during the intervention period and afterwards throughout their lives, for example, bicycling, walking, garden work, jogging or ordinary exercise, and encouraged to use a pedometer [
57].
The psycho-educational component
The patients receive five consecutive nurse consultations every 4 to 6 weeks during the first 6 months after discharge, initiated within the first month. The consultations take place in a quiet setting at the outpatient clinic or by telephone if the patient is unable to visit the hospital, and are performed by cardiology nurses with specific knowledge of patients with heart valve diseases, after a special training module in the psycho-educational intervention. Using a holistic patient view, the aim of the consultation is to improve patients’ coping strategies, disease management, provide information, and help resume daily life after heart valve surgery. The information given is based on national guidelines and standard treatment of patients after heart valve surgery, and will cover disease management including psychological challenges, and the treatment such as technical and medical questions.
The intervention is inspired by R.R. Parse’s
Human Becoming Practice Methodologies three dimensions [
58] interpreted as: (1) discuss and give meaning to the past, present and future; (2) explore and discuss events and possibilities; and (3) move along with envisioned possibilities. According to the theory, three ways of changing health are possible: (1) creative imaging; that is see, hear and feel what a situation might be like if lived in a different way; (2) affirming personal patterns and value priorities; and (3) shedding light on paradoxes, that is, looking at the incongruence in a situation and changing the view held of something. The nurse is present in the process through discussions, silent immersion and reflection, and is able to facilitate contact to or seek advice from a physician if needed. The method of R.R. Parse was chosen to apply a holistic patient approach centred on the individual person’s themes for the consultations. Furthermore, at The Heart Centre at Rigshospitalet, the method is already extensively used in the outpatient heart clinic, such as for patients with inherited heart diseases and adults with congenital heart disease, and fully documented in the COPE-ICD trial [
59]. A consultation guide is used to support the consultation (Table
2). Reported issues for patients after heart valve surgery can be: perceiving fragility, sleeping disturbances, body perception, experiencing an information gap after hospital discharge, and for some, symptoms of depression, anxiety and post-traumatic stress disorder, which will all be covered when relevant [
17,
18].
Table 2
The psycho-educational intervention: consultation guide
Discuss the events leading to heart valve surgery. Experiences before, during and after hospital admission. | x | | | | |
Address present thoughts and questions. | x | x | x | x | x |
How have you been? What has happened since you were here last time? | | x | x | x | x |
How did you having heart valve surgery affect your life? Are there things/activities you avoid? Do you in any ways feel impaired after having heart valve surgery? | | x | | x | x |
Have you initiated exercise training? How is training going? | | x | x | x | |
Discuss social network/family. How do they handle the situation? Has anything changed in your social relationships? | x | x | | x | x |
Has having heart valve surgery affected your work situation? Has it had financial consequences? | | | | x | |
Have you had a changed view/perception of your body and its functions? | | | | x | x |
How is your health in relation to fatigue, dyspnea, pain, appetite, gastrointestinal function, sleep, sexual functioning, other? | | | x | x | x |
Symptom handling and degree of dyspnea. | x | x | x | x | x |
Information/recommendations in relation to discussed issues/problems according to guidelines or if lacking to usual practice. | x | x | x | x | x |