The Added Value of a Behavioral Medicine Intervention in Physiotherapy on Adherence and Physical Fitness in Exercise-Based Cardiac Rehabilitation (ECRA): A Randomised, Controlled Trial

Figures & data

Figure 1 Flowchart of study participants.

Figure 2 Overview of the timeline of the behavioral medicine intervention.

Table 1 Baseline Demographics for Participants in the ECRA-Study, n=170

	Whole Group	Behavioral Medicine	Routine Care
	n=170	n=86	n=84
Age (years), mean (SD)	62.3 (7.9)	62.7 (7.8)	61.8 (8.0)
BMI (kg/m^2), mean (SD)	27.2 (4.1)	27.2 (4.3)	27.1 (4.0)
Sex, n (%)
Men	136 (80)	72 (83.7)	64 (76.2)
Women	34 (20)	14 (16.3)	20 (23.8)
Country born, n (%)
Sweden	165 (99.4)	86 (100.0)	79 (98.8)
Other	1 (0.6)	0 (0.0)	1 (1.3)
Relationship status, n (%)
Married/partner	135 (79.4)	69 (80.2)	66 (78.6)
Living alone	35 (20.6)	17 (19.8)	18 (21.4)
Educational level, n (%)
Elementary school	11 (6.5)	8 (9.3)	3 (3.6)
High school	32 (18.9)	13 (15.1)	19 (22.9)
Vocational school	44 (26.0)	20 (23.3)	24 (28.9)
University	82 (48,5)	45 (52.3)	37 (44.6)
Occupational status, n (%)
Employed	89 (54.6)	43 (51.2)	46 (58.2)
Retired	71 (43.6)	40 (47.6)	31 (39.2)
Sick leave	2 (1.2)	0 (0.0)	2 (2.5)
Unemployed, student, other	1 (0.6)	1 (1.2)	0 (0.0)
On sick leave at time for baseline, n (%)	41(44.6)	16 (36.4)	25 (52.1)
Smoking status, n (%)
Never smoked	73 (42.9)	36 (41.9)	37 (44.0)
Ex- smoker > 1month	83 (48.8)	45 (52.3)	38 (45.2)
Smoker	14 (8.2)	5 (5.8)	9 (10.7)
Previous diseases, n (%)
AMI	13 (7.6)	5 (5.8)	8 (9.5)
PCI	18 (10.6)	8 (9.3)	10 (11.9)
CABG	6 (3.5)	3 (3.5)	3 (3.6)
Diabetes	17 (10.0)	11 (12.8)	6 (7.1)
Hypertension	80 (47.1)	45 (52.3)	35 (41.7)
Chronic heart failure	1 (0.6)	0 (0.0)	1 (1.2)
Stroke	5 (2.9)	2 (2.3)	3 (3.6)
Type of index cardiac event, n (%)
STEMI	47 (27.6)	25 (29.1)	22 (26.2)
NSTEMI	53 (31.2)	20 (23.3)	33 (39.3)
Unstable angina	30 (17.6)	22 (25.6)	8 (9.5)
Stable angina	40 (23.5)	19 (22.1)	21 (25.0)
Type of index cardiac intervention, n (%)
PCI	163 (95.9)	83 (96.5)	80 (95.2)
Left ventricular function, n (%)
Normal (EF >50%)	93 (68.9)	53 (73.6)	40 (63.5)
Lightly reduced (EF 40–49%)	28 (20.7)	13 (18.1)	15 (23.8)
Moderate/severely reduced (EF <39%)	14 (10.4)	6 (8.3)	8 (12.7)
Medication, n (%)
ACE	63 (37.5)	34 (39.5)	29 (35.4)
ARB	47 (27.6)	27 (31.4)	20 (23.8)
Calcium inhibitors	25 (14.7)	11 (12.8)	14 (16.7)
Anticoagulants	11 (6.5)	6 (7.0)	5 (6.0)
Other platelet inhibitors	169 (99.4)	86 (100.0)	83 (98.8)
ASA	165 (97.1)	84 (97.7)	81 (96.4
Betablockers	107 (62.9)	57 (66.3)	50 (59.5)
Statins	170 (100.0)	86 (100.0)	84 (100.0)
Diuretics	9 (5.3)	3 (3.5)	6 (7.2)
Experience of exCR, n (%)	14 (8,2)	6 (7.0)	8 (9.5)

Abbreviations: BMI, body mass index; AMI, Acute Myocardial infarction; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; STEMI, ST elevation myocardial infarction; NSTEMI, Non ST elevation myocardial infarction; EF, ejection fraction; ACE, Angiotensin converting enzyme; ARB, Angiotensin receptor blocker; ASA, Acetyl salicylic acid; exCR, exercise-based cardiac rehabilitation.

Table 2 Intention-to-Treat Analysis of Change in Outcomes Within and Between Groups

Variables	Routine Care	Behavioral Medicine	Between Groups (1–2)
	n=84	n=86
Change in submaximal bicycle ergometer test (Watt)
Baseline	104.90	107.52
Mean change between baseline-16 weeks	10.40	10.76	−0.36
(CI)	(6.26 to 14.54) (p=<0.001)	(6.77 to 14.75) (p=<0.001)	(−6.14 to 5.42) (p=0.902)
16 weeks	115.30	118.28
Mean change between 16 weeks-1 year	−3.68	1.72	−5.40
(CI)	(−7.97 to 0.61) (p=0.095)	(−1.76 to 5.19) (p=0.333)	(−10.97 to 0.17) (p=0.060)
Change in unilateral isotonic heel lift (repetitions)
Baseline	12.5	13.1
Mean change between baseline-16 weeks	3.24	2.23	1.01
(CI)	(1.03 to 5.45) (p=0.004)	(0.60 to 3.86) (p=0.008)	(−1,64 to 3.66) (p=0.455)
16 weeks	15.7	15.3
Mean change between 16 weeks-1 year	−0.50	1.60	−2.10
(CI)	(−2.79 to 1.79) (p=0.666)	(−0.38 to 3.58) (p=0.113)	(−5.00 to 0.80) (p=0.157)
Change in unilateral isotonic shoulder flexion (repetitions)
Baseline	24.6	29.0
Mean change between baseline-16 weeks	8.99	8.30	0.69
(CI)	(5.21 to 12.77) (p=<0.001)	(5.03 to 11.56) (p=<0.001)	(−4.29 to 5.68) (p=0.785)
16 weeks	33.6	37.3
Mean change between 16 weeks-1 year	0.90	1.69	−0.79
(CI)	(−2.91 to 4.71) (p=0.642)	(−1.94 to 5.32) (p=0.361)	(−5.80 to 4.23) (p=0.758)
Change in the BHW PA questions (activity minutes)
Baseline	243.8	302.1
Mean change between baseline-16 weeks	101.71	65.21	36.51
(CI)	(72.39 to 131.04) (p=<0.001)	(34.95 to 95.47) (p=<0.001)	(−6.06 to 79.07) (p=0.093)
16 weeks	345.5	367.3
Mean change between 16 weeks-1 year	−29.06	−28.45	−0.61
(CI)	(−62.49 to 4.37) (p=0.093)	(−58.77 to 1.86) (p=0.068)	(−44.59 to 43.38) (p=0.978)
Change in VAS physical capacity (millimeter)
16 weeks	70.0	72.2
Mean change between 16 weeks-1 year	0.34	−2.33	2.67
(CI)	(−3.40 to 4.08) (p=0.858)	(0.95 to −5.61) (p=0.165)	(−2.34 to 7.68) (p=0.297)

Notes: Headings and significant differences are presented in bold.

Abbreviations: CI, confidence interval; BHW PA, The Swedish National Board of Health and Welfare physical activity; VAS, visual analogue scale.

Table 3 Per-Protocol Analysis of Change in Outcomes Within and Between Groups

Variables	Routine Care	Behavioral Medicine	Between Groups (1–2)
	n=13	n=23
Change in submaximal bicycle ergometer test (Watt)
Baseline	109.03	115.18
Mean change between baseline-16 weeks	17.74	10.95	6.80
(CI)	(10.15 to 25.34)(p=<0.001)	(6.52 to 15.37) (p=<0.001)	(−1.39 to 14.98) (p=0.103)
16 weeks	126.78	126.12
Mean change between 16 weeks-1 year	−0.22	3.65	−3.87
(CI)	(−6.71 to 6.27) (p=0.948)	(−1.50 to 8.80) (p=0.165)	(−12.27 to 4.54) (p=0.367)
Change in unilateral isotonic heel lift (repetitions)
Baseline	9.8	13.1
Mean change between baseline-16 weeks	7.45	4.22	3.23
(CI)	(2.68 to 12.21) (p=0.002)	(1.76 to 6.68) (p=0.001)	(−1.66 to 8.18) (p=0.196)
16 weeks	17.2	17.4
Mean change between 16 weeks-1 year	−0.89	0.03	−0.92
(CI)	(−5.25 to 3.48) (p=0.691)	(−2.13 to 2.20) (p=0.978)	(−5.37 to 3.54) (p=0.687)
Change in unilateral isotonic shoulder flexion (repetitions)
Baseline	21.2	31.4
Mean change between baseline-16 weeks	10.00	9.96	0.04
(CI)	(0.56 to 19.44) (p=0.038)	(4.37 to 15.54) (p=<0.001)	(−11.62 to 11.70) (p=0.994)
16 weeks	31.2	41.3
Mean change between 16 weeks-1 year	2.85	−0.84	3.69
(CI)	(−6.71 to 12.40) (p=0.559)	(−7.07 to 5.39)(p=0.792)	(−7.26 to 14.63)(p=0.509)
Change in the BHW PA questions (activity minutes)
Baseline	267.7	347.6
Mean change between baseline-16 weeks	151.62	99.98	51.64
(CI)	(80.83 to 222.40) (p=<0.001)	(49.96 to 150.00) (p=<0.001)	(34.61 to 137.89) (p=0.241)
16 weeks	419.3	447.6
Mean change between 16 weeks-1 year	−61.64	−63.15	1.61
(CI)	(−144.70 to 21.62) (p=0.148)	(−112.48 to −13.83) (p=0.014)	(−84.76 to 87.98) (p=0.971)
Change in VAS physical capacity (millimeter)
16 weeks	74.1	74.1
Mean change between 16 weeks-1 year	2.24	−0.41	2.65
(CI)	(−3.75 to 8.23)(p=0.462)	(−8.71 to 7.89) (p=0.922)	(−9.62 to 14.92) (p=0.672)

Notes: Headings and significant differences are presented in bold.

Abbreviations: CI, confidence interval; BHW PA, The Swedish National Board of Health and Welfare physical activity; VAS, visual analogue scale.