Early rehabilitation in CABG patients
and physical functional capacity, after CABG (9, 10).
Trials targeting psychological and psycho-educational
interventions in patients undergoing rehabilitation
have shown improvements in symptoms of depression
and anxiety (11); however, no published randomized
controlled trial using phase 1 rehabilitation for CABG
patients has had an adequate sample size (12). A pilot
trial was conducted to evaluate acceptability of inclu-
sion, feasibility and intervention compliance, which
showed high inclusion, feasibility and safety, but
moderate compliance with the physical and the psycho-
educational interventions (13). It was hypothesized that
comprehensive cardiac rehabilitation would increase
physical functioning and improve mental health.
The aim of the trial was to assess the impact of phase
1 rehabilitation and early phase 2 rehabilitation, pro-
spectively named early rehabilitation, compared with
usual care, in patients undergoing CABG based on the
primary outcome of physical function and on secon-
dary outcomes of physical and mental health, anxiety,
depression, sleep, pain and health-related quality of life.
METHODS
The SheppHeartCABG trial (“Shaping outcomes by Exercise
training and Psychoeducation in Phase 1 for Heart patients”) is
an investigator-initiated randomized controlled trial (RCT) (14).
The trial followed the principles of the Declaration of Helsinki
and was approved by the Regional Ethics Committee (H-4-
2014-109) and the Danish Data Protection Agency (30-1309).
The trial was registered at ClinicalTrials.gov (NCT02290262)
and reported according to the Con-
solidated Standards of Reporting
Trials (CONSORT).
137
sequence computer-generated using blocks varying between
4, 6, 8, 10, 12, and 14, stratified according to site and sex, and
concealed from the investigators, as allocation was done through
a web-based system. Full blinding of clinicians and participants
is impossible in a rehabilitation trial, but data collection, out-
come assessment, data management, statistical analyses, and
conclusions were blinded to the allocation group.
Intervention group
An outline of the trial interventions (14) is shown in Fig. 1
including the intervention components, the timeline for the 2
groups, and the outcome measures.
Physical exercise component
The aim of the physical intervention was to improve physical
functioning 4 weeks after CABG. The physical rehabilitation
programme was initiated the day before surgery. Patient-repor-
ted diaries and a heart-rate monitor were used to monitor. The
physical interventions were administrated by physiotherapists
and included an exercise programme starting at admission and
continued for 4 weeks after CABG. The physical intervention
was divided into respiratory physiotherapy and aerobic training.
After hospital discharge, until 4 weeks after CABG, exercise
included continuous daily walking and muscle and endurance
exercises (Fig. 1).
Psycho-educational component
The aim of the psycho-educative intervention was to improve
disease coping by applying a patient-centred approach. The
conceptual foundation for dialogue with patients was based on
the Human Becoming Practice Methodologies by Parse (15).
The consultations were performed by 6 trained nurses and
most participants met the same nurse at all consultations. A
Participants, setting and
recruitment
The settings were thoracic clinics at
2 university hospitals in Denmark:
Odense and Copenhagen. Patients
were screened consecutively for in-
clusion. First-time elective patients
undergoing CABG who provided
informed consent were included.
Patients younger than 18 years
of age, patients diagnosed with a
musculoskeletal or neurological
disease precluding exercise testing
and training, and patients who did
not speak Danish were excluded.
Potential participants received
verbal and written information at
admission and were recruited over
a period of 19 months.
Randomization and blinding
Randomization was 1:1 by central
randomization, with the allocation
Fig. 1. Trial design.
J Rehabil Med 51, 2019