Early rehabilitation in CABG patients
in the protocol were analysed with no adjustment of p-values
due to multiplicity. Instead, the interpretation of each secondary
outcome measure was assessed in the light of multiple testing.
The pre-specified per-protocol level of intervention adherence
was defined (14) as completing at least 75% of the exercise ses-
sions and consultations and using one of the mindfulness tools
on 75% of the days. However, only one participant reached that
level. Therefore, it was decided before the start of analysis to
change the per-protocol level to participation in at least 50%
of the exercise sessions and psycho-educational consultations.
Adherence to the exercise intervention was assessed using the
patient-reported exercise diary, and the recordings made for the
psycho-educational intervention at each visit.
Statistical analyses were conducted in SPSS V.22 (SPSS Inc.
IBM), R version 3.1.2 (R Foundation for Statistical Computing,
Vienna Austria) and SAS V.9.3 (SAS Institute, Cary, NC, USA).
RESULTS
Between November 2014 and June 2016, 717 patients
were identified and screened. A total of 277 patients
were excluded and 114 of the remaining 440 parti-
cipants (26%) declined to participate. A total of 326
patients were randomized (Fig. 2).
Baseline characteristics
The sex ratio was equal among those patients who
declined to participate and the included patients. In
the randomized group 11 patients dropped out from the
experimental group and 5 from the usual care group
(control group). Of the 310 remaining patients, 87%
were men, with a mean age of 65 years (range 33–83
years). NYHA class ranged from I to IV (Table I).
Outcomes
Primary outcome. There was no statistically significant
difference between the experimental and control groups
at 4 weeks after CABG on 6MWT (16.2 m (95% confi-
dence interval (CI): –13.0 to 45.4 m), p = 0.27) and no
significant interaction between intervention and time
was observed (p = 0.55). Cohen’s d was 0.14 (Table II).
Secondary outcomes. Testing the secondary outcomes
no p-value less than 0.05 was observed, except a dif-
ference in favour of the experimental intervention de-
tected on HADS-D ≥ 8 (odds ratio = 0.46 (95% CI: 0.22
to 0.97), p = 0.04) (Tables II and III). The secondary
outcomes showed a tendency toward better scores in
the experimental group on all outcomes except SF-12
PCS (Physical Component Scale).
Adherence
In the intervention group, 110/152 (72%) patients par-
ticipated in the exercise training programme with the
139
Table I. Baseline characteristics: experimental group and control
group
Age, years, mean (SD)
Male, n (%)
Female, n (%)
Marital status, n (%)
Single/divorced/widowed
Married/domestic partner
Occupational status, n (%)
Active employment
Retired
Early retirement
Person on job release scheme
Educational level, n (%)
Vocational level
College
University
None
Undisclosed
Body mass index (kg/m 2 ), n (%)
< 18.5
≥ 18.5 < 25
≥ 25 < 30
> 30
Undisclosed
Type of heart disease, n (%)
Ischaemic heart disease
Others
Undisclosed
NYHA class, n (%)
NYHA class I
NYHA class II
NYHA class III
NYHA class IV
Undisclosed
LVEF, n (%)
Normal (50–70)
Reduced (36–49)
Low (< 35)
Undisclosed
Smoker, n (%)
Current smoker
Previous smoker
Undisclosed
Diabetes mellitus, n (%)
Type I
Type II
Undisclosed
Prescribed medication, n (%)
Blood pressure-lowering drugs
ACE inhibitor
Beta-blocker
Calcium antagonist
Antiarrhythmic drugs
Antiplatelet drugs
Diuretic
Anti-diabetic
Statin
Antidepressant
Pain reliever
Sleeping pills
Experimental group
(n = 152) Control group
(n = 158)
65.0 (9.1)
132 (87)
20 (13) 65.1 (8.4)
136 (86)
22 (14)
32 (21)
120 (79) 37 (23)
121 (77)
61 (40)
86 (56)
4 (3)
1 (1) 80 (51)
76 (48)
1 (1)
1 (1)
68 (45)
37 (24)
34 (22)
2 (1)
11 (7) 90 (57)
31 (20)
22 (14)
2 (1)
13 (8)
1 (1)
39 (26)
65 (42)
46 (30)
1 (1) 1 (0.6)
35 (22)
77 (49)
40 (25)
5 (3)
102 (67)
3 (2)
46 (37) 106 (67)
5 (3)
47 (30)
44 (29)
51 (34)
30 (20)
2 (1)
22 (14) 41 (26)
60 (38)
31 (20)
5 (3)
21 (13)
112 (74)
29 (19)
9 (6)
2 (1) 106 (67)
28 (17)
20 (13)
4 (3)
20 (13)
79 (52)
2 (1) 26 (16)
86 (54)
2 (1)
6 (4)
29 (19)
1 (0.7) 7 (4)
40 (25)
0
90 (59)
26 (17)
42 (28)
33 (22)
3 (2)
126 (83)
27 (18)
24 (16)
126 (83)
9 (6)
21 (14)
12 (8)
87 (57)
32 (20)
42 (27)
37 (23)
2 (1)
134 (84)
43 (27)
0 (0)
131 ((83)
10 (6)
29 (18)
5 (3)
LVEF: left ventricular ejection fraction; NYHA: New York Heart Association
Functional Classification.
number of sessions completed depending on length of
hospitalization. Sixteen (15%) participants conducted
≥ 75% of the training programme, 35 patients (32%)
50–74%, and 59 (54%) patients carried out < 50% of
J Rehabil Med 51, 2019