Cardiac rehabilitation designed for patients with obesity: OPTICARE XL RCT results on health-related quality of life and psychosocial well-being

Figures & data

Table 1. Characteristics of OPTICARE XL CR and standard CR.

	OPTICARE XL CR	Standard CR
Duration of program	Part I: 12 weeks Part II: 9-month after-care program	6-12 weeks No after-care program
Participating patients	Only patients with obesity Group size: 6-8 patients	Patients with and without obesity Group size 10-25 patients
Exercise program	60-90 min supervised exercise sessions Combination of endurance and resistance training Designed for patients with obesity	60-90 min supervised exercise sessions Mainly endurance training Designed for patients of all BMI classes
Counselling sessions	General group information sessions on lifestyle and risk factors Facultative counselling in smoking cessation, stress management or healthy diet coaching on indication Additional intensive coaching during part I by means of two modules (in total 16 sessions), focussing on (1) healthy diet and (2) active lifestyle. Behavioural change techniques were applied, such as self-monitoring, goal setting Six booster sessions during part II	General group information sessions on lifestyle and risk factors Facultative counselling in smoking cessation, stress management or healthy diet coaching on indication No additional coaching
Technology	An activity tracker was provided to promote an active lifestyle during part I and part II Voluntary participation in a group chat in part II	No use of additional technologies

Figure 1. Flow diagram. Primary end point in red.

Included patients were randomized into one of two groups: OPTICARE XL CR (n = 102) or standard CR (n = 99). Six months post CR (primary study end point), 26 patients in the OPTICARE XL CR group and 12 patients in the standard CR group were lost to follow-up. Reasons for lost to follow-up were motivational problems, not answering calls or e-mails, and lack of time.

Table 2. Baseline characteristics study population (n = 201).

	OPTICARE XL CR (n = 102)	Standard CR (n = 99)
Males, n (%)	68 (66.7)	78 (78.8)
Age (years)^a	59.0 ± 10.0	59.2 ± 8.8
BMI (kg/m^2)^b	34.4 ± 4.7	34.1 ± 4.6
Reason for referral to CR and treatment, n (%)
• CAD	62 (60.8)	71 (71.7)
– Percutaneous coronary intervention	45 (72.6)	53 (74.6)
– Coronary artery bypass graft	9 (14.5)	10 (14.1)
– No revascularization	8 (12.9)	8 (11.3)
• AF	40 (39.2)	28 (28.3)
– without ablation	33 (82.5)	24 (85.7)
– with ablation	7 (17.5)	4 (14.3)
Marital status, n (%)
• Partnered	71 (74.7)	69 (77.5)
• Unpartnered	24 (25.3)	20 (22.5)
Missing	7	10
Educational level, n (%)
• Low	8 (8.5)	5 (5.7)
• Intermediate	58 (61.7)	65 (73.9)
• High	28 (29.8)	18 (20.5)
Missing	8	11
Work status, n (%)
• Employed	50 (53.2)	56 (66.7)
• Unemployed	44 (46.8)	28 (33.3)
Missing	8	15
Risk factors, n (%)
• Family history of CVD	48 (47.1)	50 (50.5)
• Diabetes	29 (28.4)	28 (28.3)
• Hypertension	57 (55.9)	57 (57.6)
• Dyslipidaemia	33 (32.4)	49 (49.5)
• Smoking before CR	33 (32.4)	25 (25.3)

CR: cardiac rehabilitation; CAD: coronary artery disease; AF: atrial fibrillation; CVD: cardiovascular disease.

^aNormally distributed: mean ± SD.

^bNot normally distributed: mean ± IQR.

Table 3. Mean health-related quality of life at the start of CR, at six months post CR, and mean change for OPTICARE XL CR and standard CR group separately, as well as difference in change between groups.

		OPTICARE XL CR (mean and 95% CI)	Standard CR (mean and 95% CI)	Difference in change between OPTICARE XL CR and standard CR (p-value)
HRQOL global (n = 191)	Start of CR	4.96 (4.72, 5.19)	4.92 (4.66, 5.18)	0.907
	Six months post CR	5.45 (5.19, 5.71)	5.40 (5.12, 5.67)
	Δ	0.49 (0.29, 0.70)^b	0.48 (0.28, 0.67)^b
HRQOL physical function (n = 191)	Start of CR	4.60 (4.34, 4.87)	4.63 (4.34, 4.93)	0.614
	Six months post CR	5.30 (5.00, 5.59)	5.24 (4.93, 5.55)
	Δ	0.69 (0.46, 0.92)^b	0.61 (0.39, 0.83)^b
HRQOL emotions (n = 192)	Start of CR	4.92 (4.67, 5.18)	4.77 (4.49, 5.06)	0.546
	Six months post CR	5.23 (4.95, 5.52)	5.18 (4.88, 5.47)
	Δ	0.31 (0.08, 0.53)^a	0.40 (0.19, 0.62)^a
HRQOL social participation (n = 190)	Start of CR	5.45 (5.19, 5.72)	5.45 (5.15, 5.74)	0.435
	Six months post CR	6.04 (5.74, 6.33)	5.90 (5.59, 6.21)
	Δ	0.58 (0.35, 0.82)^b	0.45 (0.22, 0.68)^a

Results are based on multivariable linear mixed-effect modelling. Patients were included in the analysis if at least one measurement (baseline or follow-up) was available.

CR: cardiac rehabilitation; HRQOL: health-related quality of life.

^aSignificant (within group) change over time (p < 0.05).

^bSignificant (within group) change over time (p < 0.0001).

Table 4. Mean scores on anxiety, depression, fatigue and participation in society at the start of CR, at six months post CR, and mean change for OPTICARE XL CR and standard CR group separately, as well as difference in change between groups.

		OPTICARE XL CR (mean and 95% CI)	Standard CR (mean and 95% CI)	Difference in change between OPTICARE XL CR and standard CR (p-value)
Anxiety (HADS-A score) (n = 184)	Start of CR	5.8 (4.9, 6.7)	6.4 (5.4, 7.4)	0.274
	Six months post CR	5.1 (4.1, 6.0)	5.1 (4.1, 6.1)
	Δ	−0.7 (−1.4, 0.0)^a	−1.3 (−2.0, −0.6)^a
Depression (HADS-D score) (n = 187)	Start of CR	4.3 (3.3, 5.2)	5.0 (4.0, 6.0)	0.429
	Six months post CR	3.5 (2.5, 4.5)	3.8 (2.8, 4.9)
	Δ	−0.7 (−1.5, 0.0)	−1.2 (−2.0, −0.4)^a
Fatigue (FSS score) (n = 181)	Start of CR	4.3 (3.9, 4.6)	4.3 (3.9, 4.7)	0.464
	Six months post CR	3.8 (3.4, 4.2)	3.6 (3.2, 4.0)
	Δ	−0.5 (−0.9, −0.1)^a	−0.7 (−1.1, −0.3)^a
Participation in society (satisfaction score) (n = 188)	Start of CR	67.0 (62.8, 71.3)	66.0 (61.2, 70.7)	0.312
	Six months post CR	77.5 (72.7, 82.4)	73.2 (68.1, 78.2)
	Δ	10.5 (6.0, 15.0)^b	7.2 (2.8, 11.7)^a
Participation in society (perceived restrictions score) (n = 191)	Start of CR	83.3 (79.8, 86.8)	83.2 (79.3, 87.1)	0.886
	Six months post CR	88.6 (84.7, 92.6)	88.9 (84.8, 93.0)
	Δ	5.3 (1.9, 8.7)^a	5.7 (2.4, 9.0)^a

Results are based on multivariable linear mixed-effect modelling. Patients were included in the analysis if at least one measurement (baseline or follow-up) was available.

CR: cardiac rehabilitation; HADS: hospital and depression scale; FSS: fatigue severity scale.

^aSignificant (within group) change over time (p < 0.05).

^bSignificant (within group) change over time (p < 0.0001).

Table 5. Mean health-related quality of life at the start of CR, at three months after start of CR, and mean change for OPTICARE XL CR and standard CR group separately, as well as difference in change between groups.

		OPTICARE XL CR (mean and 95% CI)	Standard CR (mean and 95% CI)	Difference in change between OPTICARE XL CR and standard CR (p-value)
HRQOL Global (n = 194)	Start of CR	4.93 (4.70, 5.15)	4.90 (4.65, 5.15)	0.169
	Three months after start	5.55 (5.32, 5.78)	5.35 (5.10, 5.61)
	Δ	0.62 (0.45, 0.79)^b	0.45 (0.28, 0.63)^b
HRQOL physical function (n = 194)	Start of CR	4.56 (4.31, 4.82)	4.60 (4.32, 4.88)	0.238
	Three months after start	5.35 (5.09, 5.61)	5.22 (4.93, 5.50)
	Δ	0.79 (0.59, 0.99)^b	0.62 (0.41, 0.82)^b
HRQOL emotions (n = 194)	Start of CR	4.87 (4.63, 5.12)	4.74 (4.47, 5.02)	0.223
	Three months after start	5.40 (5.15, 5.66)	5.10 (4.82, 5.38)
	Δ	0.53 (0.34, 0.73)^b	0.36 (0.15, 0.56)^a
HRQOL social participation (n = 193)	Start of CR	5.47 (5.21, 5.73)	5.48 (5.19, 5.76)	0.181
	Three months after start	6.09 (5.83, 6.35)	5.90 (5.62, 6.19)
	Δ	0.62 (0.42, 0.82)^b	0.42 (0.22, 0.63)^a

Results are based on multivariable linear mixed-effect modelling. Patients were included in the analysis if at least one measurement (baseline or follow-up) was available.

CR: cardiac rehabilitation; HRQOL: health-related quality of life.

^aSignificant (within group) change over time (p < 0.05).

^bSignificant (within group) change over time (p < 0.0001).

Table 6. Mean scores on anxiety, depression, fatigue and participation in society at the start of CR, at three months after start of CR, and mean change for OPTICARE XL CR and standard CR group separately, as well as difference in change between groups.

		OPTICARE XL CR (mean and 95% CI)	Standard CR (mean and 95% CI)	Difference in change between OPTICARE XL CR and standard CR (p-value)
Anxiety (HADS-A score) (n = 185)	Start of CR	5.9 (5.0, 6.7)	6.3 (5.4, 7.3)	0.236
	Three months after start	5.0 (4.1, 5.8)	4.9 (3.9, 5.9)
	Δ	−0.9 (−1.5, −0.3)^a	−1.4 (−2.1, −0.8)^b
Depression (HADS-D score) (n = 188)	Start of CR	4.4 (3.5, 5.3)	5.1 (4.1, 6.1)	0.662
	Three months after start	3.5 (2.5, 4.4)	4.3 (3.3, 5.3)
	Δ	−1.0 (−1.5, −0.4)^a	−0.8 (−1.4, −0.2)^a
Fatigue (FSS score) (n = 186)	Start of CR	4.3 (3.9, 4.7)	4.3 (3.9, 4.7)	0.324
	Three months after start	3.6 (3.3, 4.0)	3.8 (3.4, 4.2)
	Δ	−0.7 (−1.0, −0.4)^b	−0.5 (−0.8, −0.2)^a
Participation in society (satisfaction score) (n = 187)	Start of CR	67.6 (63.3, 72.0)	67.1 (62.6, 72.0)	0.709
	Three months after start	73.7 (69.3, 78.2)	72.3 (67.2, 77.4)
	Δ	6.1 (2.8, 9.4)^a	5.2 (1.7, 8.7)^a
Participation in society (perceived restrictions score) (n = 191)	Start of CR	83.4 (79.9, 86.9)	83.4 (79.5, 87.3)	0.030^a
	Three months after start	90.5 (86.9, 94.0)	86.6 (82.6, 90.6)
	Δ	7.1 (4.7, 9.5)^b	3.2 (0.6, 5.7)^a

Results are based on multivariable linear mixed-effect modelling. Patients were included in the analysis if at least one measurement (baseline or follow-up) was available.

CR: cardiac rehabilitation; HADS: hospital and depression scale; FSS: fatigue severity scale.

^aSignificant (within group) change over time (p < 0.05).

^bSignificant (within group) change over time (p < 0.0001).

World Health Organization. Obesity and overweight fact sheet no 311 [cited 2020 May]. Available from: http://www.who.int/mediacentre/factsheets/fs311/en/

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Data availability statement

The data underlying this article are available in DANS, at https://easy.dans.knaw.nl/ui/datasets/id/easy-dataset:204552