1. Women’s Health Behaviours Following Referral to 3 Different
Cardiac Rehabilitation Program Models:
A Randomized Controlled Trial
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clinicaltrials.gov Registration #NCT
L Midence, MSc1; HM Arthur, PhD2; P Oh, MD3; S Brister, MD3; C Chessex, MD3; DE Stewart, MD3; SL Grace, PhD1, 3
1York University, 2Hamilton Health Sciences Centre, 3University Health Network - Ontario, Canada
BACKGROUND
CVD is the leading cause of death globally
Cardiac rehabilitation (CR) participation is associated with significantly lower morbidity and mortality,
Benefits are due to, among other factors, adherence to a heart-healthy lifestyle
New models of CR have been developed, such as women-only programs, to better meet their needs
OBJECTIVE
To test whether participation in women-only CR results in significantly better health behaviours when compared to participation in co-ed or home-based CR.
RESULTS
Participant Characteristics by
Post-Program Survey Retention
Medication Adherence
by Randomized Model
Excluded n=1847 (91.6%)
Declined n=739 (40.0%)
INELIGIBLE:
Lives and works too far from CR sites n=375 (20.3%)
Does not speak/read English n=196 (10.6%)
No cardiac diagnosis or procedure meeting inclusion criteria n=162 (8.8%)
Referral to CR program prior to randomization n=100 (5.4%)
Musculoskeletal, neuromuscular, vision, cognitive or non-dysphoric psychiatric condition/too ill n=86 (4.6%)
Not eligible for home-based CR n=68 (3.7%)
Recent participation in CR n=25 (1.4%)
Planning to leave the province n=23 (1.2%)
Did not consent to randomization n=20 (1.1%)
Discharged to long-term care n=17 (1.0%)
Enrolled in other study with behavioral intervention n=8 (0.4%)
Patient passed away n=5 (0.3%)
Physician clearance not received n=5 (0.3%)
Other n=18 (1.0%)
Allocation
Enrollment
Randomized n=169 (8.4%)
Assessed for eligibility
n= 2016
Analysis
Returned T2 survey=38 (69.1%)
Returned T2 pedometer=21 (38.2%)
Returned T2 survey=36 (65.5%)
Returned T2 pedometer=19 (34.5%)
Follow-Up
Returned T2 survey=42 (71.2%)
Returned T2 pedometer=15 (25.4%)
Women-only n=55 (32.5%)
Received allocated intervention n=35 (63.6%)
Did not receive allocated intervention n= 14 (25.4%)
Did not attend n=5 (9.1%)
Home-based n=55 (32.5%)
Received allocated intervention n=24 (43.6%)
Did not receive allocated intervention n= 25 (45.5%)
Did not attend n=6 (10.9%)
Mixed-sex n=59 (34.9%)
Received allocated intervention n=39 (66.1%)
Did not receive allocated intervention n=6 (10.2%)
Did not attend n=14 (23.7%)
Analysed survey n=38
(4 excluded due to no T1 survey)
Analysed pedometer n=11
(4 excluded due to no T1 pedometer)
Analysed survey n=32
Analysed pedometer n=12
(7 excluded due to no T1 pedometer)
Analysed survey n=35
(3 excluded due to no T1 survey)
Analysed pedometer n=15
(6 excluded due to no T1 pedometer)
Characteristics
Returned T2 survey
Lost to follow-up
Total
n=116
(68.6%)
n=53
(31.4%)
n = 169
Sociodemographic
Age, years (mean ± SD)
64.79 ± 9.57
61.10 ± 11.80
63.64 ± 10.42*
Marital Status, n (% married)
50 (47.6%)
22 (56.4%)
72 (50.0%)
Work Status, n (% retired)
56 (53.3%)
16 (41.0%)
Ethnicity, n (% white)
65 (61.9%)
25 (64.1%)
90 (62.5%)
Education, n (% post-secondary)
40 (38.1%)
14 (35.9%)
54 (37.5%)
Gross Annual Family Income (% <$50,000 CDN)
58 (55.2%)
28 (71.8%)
86 (59.7%)
Provide care to someone in household, n (% yes)
6 (9.1%)
10 (37%)
16 (17.2%)**
Have children, n (% yes)
88 (85.4%)
32 (84.2%)
120 (85.1%)
Clinical
Indication for CR
PCI (% yes)
56 (49.1%)
25 (49.0%)
81 (49.1%)
Angina/ACS/CAD (% yes)
37 (33.0%)
22 (43.1%)
59 (36.2%)
MI (% yes)
40 (35.4%)
19 (36.5%)
59 (35.8%)
CABG (% yes)
29 (25.4%)
13 (25.5%)
42 (25.5%)
Valve (% yes)
26 (23.0%)
6 (11.5%)
32 (19.4%)
Risk Factors
Dyslipidemia (% yes)
70 (84.3%)
34 (81.0%)
104 (83.2%)
Hypertension (% yes)
68 (73.1%)
33 (80.5%)
101 (75.4%)
Obesity
35 (44.9%)
14 (36.8%)
49 (42.2%)
Diabetes
23 (28.8%)
15 (42.9%)
38 (33.0%)
Comorbidities
Musculoskeletal Impairment (% yes)
14 (15.9%)
6 (13.6%)
20 (15.2%)
Depression (% yes)
10 (11.4%)
5 (11.6%)
15 (11.5%)
Cancer (% yes)
6 (6.7%)
2 (4.9%)
8 (6.2%)
Hyperthyroid (% yes)
4 (4.5%)
2 (4.8%)
6 (4.6%)
Renal Disease (% yes)
2 (2.3%)
4 (3.1%)
PAD/PVD (% yes)
1 (1.1%)
1 (2.4%)
2 (1.5%)
Liver Disease (% yes)
0 (0.0%)
1 (0.8%)
Intake Assessment
Resting Heart Rate (BPM)
75.15 ± 14.80
76.38 ± 15.73
75.54 ± 15.06
Waist Circumference (cm)
92.53 ± 12.95
97.28 ± 16.42
94.15 ± 14.34
Peak METS
5.16 ± 2.08
4.73 ± 1.76
5.03 ± 1.99
Peak VO2 (mL/(kg•min)
18.10 ± 7.29
16.59 ± 6.17
17.62 ± 6.97
ANCOVA adjusted for baseline adherence, age and caregiving (p=.62); mean MMA score ± standard deviation where >2 indicates adherent patients
DESIGN
Single-blind, 3 parallel-arm ,pragmatic randomized controlled trial, with 1:1:1 allocation concealed.
Female patients were randomized to 1 of 3 CR models at closest of 3 sites
The randomization sequence was computer-generated, in blocks of 6, and stratified by cardiac condition.
METHODS
Low-risk female coronary artery disease patients were recruited from 6 inpatient and outpatient cardiac settings in the Greater Toronto Area of Ontario, Canada.
Consenting participants completed a pre-program survey assessing health behaviours:
Godin – self-reported physical activity
Diet Habit Survey – eating habits
Morisky – medication adherence
Investigator-generated item – smoking behaviour
Also wore a pedometer for 7 days
Six months later participants were mailed a follow-up survey, and again wore a pedometer
Pre-specified secondary objective of trial
FINDINGS
Patients walked over 6500 steps/day, were highly active, consumed low-fat diet, and were highly adherent to their medications (even pre- CR)
There were few smokers (n=8; 4.7%)
Overall there was a significant increase in self- reported PA pre to post CR (p<.001)
There was a trend towards improved overall diet pre to post-program (p=.09).
In the “intention-to-treat” analyses, there were no significant differences in any health behaviours by model (see Figs)
LIMITATIONS:
Potential selection bias – low-risk participants, interested in exercise
Generalizability – other health care systems
CONCLUSIONS
Women’s health behaviours were either excellent pre-CR or significantly improved during CR, no matter which program model they participated in.
19 (11.7%) participants did not enroll in CR, and 43 (25.4%) attended a different model than the program to which they were randomly-allocated.
*Denotes significant difference between pre and post-CR measures using t-tests or chi-squares p<.05; **p<.01; ***p<.001).
Pedometer Step Count
by Randomized Model
Self-Reported Physical Activity
by Randomized Model
Diet Score
by Randomized Model
ANCOVA adjusted for baseline diet, age and caregiving (p=.51); mean DHS score ± standard deviation where >6500 is equivalent to ≈ 25% fat diet
ANCOVA adjusted for baseline steps, age, incidence of valve surgery, and intake peak VO2 values (p=.98); mean steps± standard deviation, where >6500 is equivalent to ~150 min MVPA/week
ANCOVA adjusted for baseline Godin, age and caregiving (p=.42); mean Godin score ± standard deviation where >20 is equivalent to high PA