Heart disease is the leading cause of mortality in women worldwide, and is responsible for one-third (8.6 million) of the world's deaths among women each year.1 It is well established that women who attend conventional exercise-based cardiac rehabilitation (CR) programs have better outcomes.2–4 However, even though women have increased heart disease morbidity, they are less likely to participate in secondary as opposed to primary prevention programs,1,5 and completion rates among women who do attend CR are low.6 Identifying the best possible gender-specific secondary preventative strategies is essential to facilitate and encourage engagement in programs that mediate cardiovascular risk.
The gender bias that exists in providing CR services is multifaceted at the patient, provider, and health system levels.7,8 Women are under-referred to CR9 (39.6% vs 49.4% for men)10 and fewer women participate in CR programs (38% vs 45% for men) overall.7 Under-referral of women to CR programs is problematic given that physician support and/or automatic referral7 has been identified as vital to women's participation.11 The mortality rate of women who participate in preventative heart disease clinical trials is also disproportionately high compared with their representation, which is significant given that these clinical trials are used to inform national guidelines for CR implementation.12
Awareness of the impact of heart disease is low among women, with only half of Caucasian women and one-third of ethnic minorities identifying heart disease as their leading cause of death.13 Women in minority populations have identified lack of confidence, cultural misconceptions, such as limited knowledge of anatomy and physiology, association of heart disease with disability, perceived risk of greater harm,12 restriction of physical activity, and language barriers as inhibitors to participation in CR programs.14 For these reasons, tailored and targeted preventive education programs, such as the “Go Red for Women” and “Making the Invisible Visible” campaigns, have been implemented to increase community awareness and empower women to identify and address their cardiovascular risk.1
Women have different baseline clinical profiles compared with men, which presents additional barriers to participation in traditional exercise-based programs and achieving optimal CR outcomes.11 Women are generally 10-y older when they experience their first cardiac event,15,16 more likely to be from culturally and linguistically diverse populations, unemployed, hypertensive, diabetic,11,17 have greater shortness of breath, more chronic illnesses,15,17 lower levels of physical function, and self-efficacy.8 Decision-making around CR utilization disproportionately affects older women compared with men, as older adults are given lower priority in access to CR programs.18 Older women are more likely to be reliant on others, or public transportation, further hindering their participation in CR programs.15
The American Heart Association guidelines19 recommend integration of novel strategies to address secondary prevention outcomes for women, including depression11,12 and other psychosocial risk factors. However, implementation of comprehensive gender-specific strategies20 within conventional CR programs is slow.17,18 Women have specific educational needs and respond to group-based collaborative approaches such as mutual aid.20 Women may also have preferences for CR program features or components that are not always included in traditional exercise-based CR, such as exercise monitoring, nutritional counseling, staff contact, and accessibility,11 and may benefit from different rehabilitation strategies.16 To date, research comparing benefits of different CR approaches for women is minimal. Therefore, the purpose of this literature review was to (1) determine the effectiveness of interventions designed specifically for women with heart disease, or modifiable risk factors for heart disease, delivered in outpatient CR programs; and (2) classify key elements of effective CR interventions designed to improve outcomes for women with heart disease or modifiable risk factors for heart disease.
Studies were included if they recruited women with modifiable cardiovascular risk factors for heart disease; coronary heart disease; valvular disease; heart failure; had undergone a coronary artery bypass or heart valve surgery; pacemaker or defibrillator insertion or pericardial window or a diagnostic/interventional procedure (coronary angiogram, percutaneous coronary intervention, ablation, or other procedure); or had been referred for outpatient CR (phase 2 OCR). Outpatient CR is defined by the American Association of Cardiovascular and Pulmonary Rehabilitation, American College of Cardiology, and American Heart Association as “a program that delivers preventive and rehabilitative services to patients in the outpatient setting early after a cardiovascular disease (CVD) event, generally within the first 3 to 6 mo after the event but continuing for as long as 1 year after the event.”21 The interventions that offered enhanced CR approaches as alternatives or adjuncts to OCR were included. These enhanced models included physical activity, health education, counseling, behavior modification strategies, and/or support for self-management. Control groups were defined as no intervention. Comparison groups included usual care, defined as conventional phase 2 CR programs offered in outpatient health care settings, and other similar models. All outcomes were considered. Exclusion criteria were interventions involving men or pediatric populations, and phase 1 CR interventions that were entirely inpatient-based. Articles not in English and dissertations were excluded.
This systematic review was completed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 Checklist. Databases searched included MEDLINE, Excerpta Medica DataBASE (EMBASE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Cochrane Database of Systematic Reviews from 1974 to current, last searched on July 5, 2017. Reference lists were searched for additional articles. The search strategy for EMBASE is available in Supplemental Table 1 (see Supplemental Digital Content 1, available at: http://links.lww.com/JCRP/A70).
STUDY SELECTION AND DATA COLLECTION PROCESS
All randomized controlled trials (RCTs) of OCR programs tailored for women were included. The title and the abstract were screened for eligibility and all duplicates were removed by 1 of the authors (A.R.). The process was repeated independently by a second author (P.N.). Discrepancies regarding articles for inclusion were resolved by consensus (P.N. and A.R.). Heterogeneity between interventions precluded the use of a meta-analysis and results were synthesized in narrative form. To classify the elements of included interventions, each line of text describing the interventions was coded by 1 investigator22 (A.R.). Each element was listed in a table until all were included. Common elements of positive studies were then identified and tallied across interventions.
RISK OF BIAS
Assessment of risk of bias within and across studies was reported in accordance with the Cochrane tool for assessing the risk of bias.23
The initial search generated 2166 articles. After a process of review, elimination, and hand searching, 3 RCTs—reported across 11 peer-reviewed journal articles—were identified and included in the review (Figure).
Two-thirds of the included RCTs involving women referred to CR programs were conducted in the United States (n = 2), with the other conducted in Canada (n = 1). Interventions included women-only CR exercise programs with gender-specific education on comorbidity self-management (1 study); combined exercise with motivational behavioral enhancement with interviews (1 study); and a multicomponent education-based intervention (1 study). The mean number ± standard deviation of participants across the RCT was 241 ± 68, and mean age was 63.4 y ± 0.3. Inclusion criteria were adult women with a history of diagnosed coronary heart disease including myocardial infarction (2 studies; n = 67), coronary artery bypass surgery (2 studies; n = 98), percutaneous coronary interventions (3 studies; n = 343), stable angina (1 study; n = 22), angina/acute coronary syndrome/coronary artery disease (2 studies; n = 428), and valve surgery (1 study; n = 32). The frequency of CR interventions ranged from weekly sessions for 8 wk to 3 times/wk for 12 wk (mean 24 ± 21 sessions). The women-only CR intervention duration was 1 hr, whereas the duration of 2 education-based programs ranged between 30 min and 1 hr.24,25 Primary outcomes, where clearly defined, included adherence to secondary prevention guidelines25 and CR program adherence.26 The primary outcome was not clearly defined in 1 study.27 Characteristics of included studies are described in the Table.
ASSESSMENT OF RISK OF BIAS
All 3 studies had a high risk of bias due to inability to blind participants and personnel, which is not practicable in complex interventions. Aside from this risk, the risk of bias was low in 1 study and unclear in 2 studies. An unclear risk of bias was assigned in these 2 studies for a possible selection bias due to unclear randomization (n = 1) and allocation concealment procedures (n = 1); and possible detection bias due to unclear blinding of outcome assessors for patient-reported outcomes (n = 1). Attrition and reporting bias was low across studies. A Cochrane risk of bias assessment detailing the risk assigned to interventions is available in Supplemental Table 2 (see Supplemental Digital Content 2, available at: http://links.lww.com/JCRP/A71).
USUAL CARE OR COMPARISON GROUPS
Usual care or comparison groups were clearly defined in all 3 studies. They included encouragement to attend CR and exercise 3 times/wk,25 or a mixed gender exercise training program.26,28
Two out of 3 studies had clearly defined primary outcomes, such as adherence to secondary prevention guidelines,25 and program adherence.26 Secondary outcomes included statistically significant improvements in metabolic syndrome measures and inflammatory biomarkers,29 depression,30,31 anxiety,31 health perception,32 heart rate recovery,28 quality of life,31,33,34 exercise capacity,35 functional capacity,26 CR model adherence, satisfaction and preferences,36 heart health behaviors,31 and social support31 (further details can be found in the Table).
ELEMENTS OF CR INTERVENTIONS
Two studies encompassed comprehensive counseling and educational based strategies that addressed risk factors for heart disease (eg, smoking cessation, nutrition, and blood pressure control), exercise and medication management, of which 1 study demonstrated statistically significant improvements in general health perception, social functioning, vitality, mental health,32 quality of life,33 depression,30 blood pressure,35 and a metabolic syndrome biomarker.29 Common elements to both studies were the identification of secondary prevention goals by the participants, provision of feedback, and negotiation/agreement on achievable goals; a collaborative focus; and provision of an education booklet with information around cardiovascular risk factors and rationale and strategies for goal attainment.25,29,30,32,33,35 The successful phase 3 clinical trial by Beckie24 utilized educational material that was interactive with homework exercises to integrate strategies for change. This study also utilized motivational interviewing for risk factor modification, with an emphasis on a “stage-matched approach,” whereby women identified their own reasons and advantages for behavior change and readiness for change.24 Motivational interviewing also involved affirmation of self-directed goals and building confidence for women to cope with obstacles, thereby supporting successful change and adherence from giving advice without participant permission.24 These motivational interviewing counseling sessions were conducted by either a clinical psychologist or a clinical nurse specialist. Social support, group comment and reflection, and role-play techniques were a part of the intervention, and relaxation strategies such as progressive muscle relaxation, deep breathing, and guided imagery were used at the beginning of each session.
An alternative educational approach included advice from a prevention facilitator, who was an allied health professional, regarding tailored behavior change recommendations specific to participant needs.25 This study also utilized a problem-solving approach for practical considerations associated with nonparticipation, such as transportation; however, this study did not demonstrate statistically significant improvements in adherence to cardiovascular disease prevention guidelines. Anxiety was significantly improved in 1 study with women-only CR and education sessions, with additional focus on comorbidities specific to women.26
This review identified that there are limited data to support evidence-based tailored CR models for women to improve their cardiovascular risk. The findings are overall inconclusive due to the inability of these studies to reach recruitment targets of an adequately powered RCT. However, preliminary findings suggest that motivational interviewing and an educational intervention based on the Trans-theoretical Model for behavior change can generate statistically significant improvements in a range of physiological outcomes including general health, vitality, social functioning and mental health,32 depression,30 and quality of life.33 Reductions in depression, increased comfort in work attire and increased satisfaction with behavior change counseling are also tentatively supported using a gender-specific CR approach compared with mixed sex exercise and education sessions.26
The key common elements of positive CR models included (1) inclusion of a manual for participants to guide an exercise program or to provide theoretical knowledge of cardiovascular risk factors; (2) rationale for risk factor modification and goal development strategies; and (3) use of qualified health care personnel with specialized training in motivational interviewing to guide educational or counseling-based interventions.
Strategies to enhance group cohesion and social support37 among women are an effective educational approach to CR to improve behavior change and adherence to therapy.38 Favorable outcomes may predominate when the focus of the model for cardiovascular risk reduction is collaborative and participant-driven with intent to diminish resistance and communicate empathy and acceptance,24 as opposed to a goal, action, and outcome-driven focus. Motivational interviewing could enhance reframing processes required for women to integrate experiences of their cardiac event, and is a tailored approach that can identify individual differences in support needs of women.39 Facilitated group discussion and health education meetings have demonstrated improvements in physiological and psychological outcomes for women with pre-existing heart failure or heart disease in the home setting, supporting further research using these approaches within gender-specific CR programs.40–43
The need to identify different CR models that increase participation, reduce readmission rates, and improve quality of life and health-related outcomes has been recognized.44 Advice on how to implement recommendations received during CR exercise and education sessions is also currently lacking and an identified need among women enrolled in CR programs.39 A previous phase 3 RCT demonstrated that conventional CR was most cost-effective for women when programs were delivered over an extended 1-y period compared with the standard 12-wk duration.45 This may reflect the social and emotional support needs of women attending CR programs, with longer durations reflecting increased periods required for the development of supportive networks and relationships.46 It is also likely to enable women to regain a feeling of “everydayness,” which has no specified time frame, as well as the resumption of roles and responsibilities.39(p24) While none of the interventions identified in this review were longer than 12 wk, this duration could be incorporated in future CR study designs.19 CR models are more likely cost-effective when participants are accurately referred to the program of best fit, based on levels of cardiac risk, reason for referral and demographic characteristics including gender.45 Effective resource utilization within CR programs could include tailored women-only exercise and education sessions, particularly as some women do not feel comfortable in mixed groups to ask questions,39 and ethnic minority populations require gender and cultural sensitivity to enable participation.14
To enhance CR utilization by underserved populations, including women, integrated solutions that address patient, provider, and health system factors are required.47 Gender-specific CR programs for women that are tailored to address physiological and psychosocial factors, for example, by providing women with an opportunity to ask questions and seek reassurance about their symptoms, may be 1 way to enhance engagement between health care providers and participants.19,48 Such collaborative efforts in CR programs are required to shift perspectives toward the role of CR programs as an integrated component of the cardiac care model rather than an optional addition to standard cardiac care.47
This review is limited by the inability to conduct meta-analyses, given the heterogeneity of included studies and the small number of methodologically strong RCTs. The included studies were limited by small sample sizes, and some lacked sufficient details of interventions. These issues inhibit study replication and decrease the generalizability of the findings. Variation in methods of delivery and study settings also reduced generalizability.
IMPLICATIONS FOR PRACTICE
To increase the impact of CR programs for women, comprehensive multicomponent approaches that incorporate participant-driven collaborative models to adequately address psychosocial risk factors are required. However, elements of these approaches may not suit the needs of all women, particularly given that younger women attending CR are likely to have higher stress levels and may respond better to models that have more emphasis on stress reduction,24 while older women are more likely to exhibit higher rates of depression.49 The needs of women participating in CR programs differ from those of men due to competing demands such as employment and household responsibilities. These may reduce participation and undermine the relative importance of CR.20,50,51 Multicomponent strategies that are affirming for women, such as facilitated group discussion and social support, may be more likely to encourage participation and integration of practices that reduce cardiovascular risk. This is consistent with the findings of one multicomponent CR strategy tailored for women that increased educational attendance by 31% and exercise attendance by 4 sessions.51 Such strategies are also more likely to enhance physical, social, and symbolic safety that has been previously identified as important elements of the female CR environment.52 Determining preferences for home- or hospital-based CR models and referring accordingly has also been identified as an appropriate approach to enhance utilization and thereby decrease cardiovascular risk.53
IMPLICATIONS FOR RESEARCH
There is a significant lack of RCTs based on enhanced CR approaches specifically designed for women. To progress gender-specific CR research, adequately powered RCTs tailored to women that include multicomponent approaches are required to adequately identify the combination of strategies that demonstrate improvements in cardiovascular risk. Clear reporting of intervention designs and methodologies, including randomization, allocation concealment, and blinding procedures, is also required in future studies.
There is limited evidence available to better understand and provide evidence-based tailored CR models for women to improve their cardiovascular risk. Defining the optimal models for secondary prevention of heart disease within OCR programs tailored for women is essential to optimize physiological function and improve psychosocial risk. While results were inconclusive, multicomponent CR programs that incorporated participant-driven collaborative models resulted in improvements in psychosocial risk and quality of life among women with heart disease. Further large-scale RCTs are required to confirm positive findings and better understand what combination of strategies is most likely to improve adherence to CR guidelines and optimize functional independence and quality of life.
This research was supported by an Australian Research Council Discovery Grant (DP120101148).
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