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Comparing Two Methods of Rehabilitation for Risk Factor Modification After a Cardiac Event (CE)
Because fewer than half of cardiac patients in the United States enroll in cardiac rehabilitation (CR) programs, there is a critical need to test alternative strategies of delivering CR services. This study tested whether a home-based CR (home-CR) program was at least as effective as traditional-CR (trad-CR) in the modification of coronary heart disease risk factors from the beginning of CR (baseline) to 2 and 4 months later. A repeated measures non-inferiority quasi-experimental design was used to examine changes in risk factors. Participants selected which CR program, traditional versus home-based, in which to participate: 37 patients chose trad-CR and 24 patients chose home-CR. The following indicators of risk factors were measured: smoking, blood pressure, frequency of aerobic exercise, cholesterol, amount of dietary fat, frequency of anger, body mass index (BMI), and waist circumference. Home-CR was found to be as effective as trad-CR in modification of cardiac risk factors including BMI, waist circumference, blood pressure, frequency of aerobic exercise, total cholesterol, and a low fat diet. Home-CR was not as effective as trad-CR in reducing the frequency of anger. These findings provide support for an alternative method of delivering cardiac rehabilitation services.
The current standard of practice guidelines from the American College of Cardiology and the American Heart Association for promoting secondary prevention of coronary heart disease (CHD) after a cardiac event is referral of patients to a Phase II cardiac rehabilitation (CR) program (Eagle et al., 2004; Smith et al., 2001). CR programs are designed not only to involve patients in a prescribed exercise and risk factor modification program, but also to provide education and counseling to limit the physiologic and psychological effects of cardiac illness and enhance the psychosocial and vocational status of patients (Wenger et al., 1995). The efficacy of traditional cardiac rehabilitation is well established. Pooled data from clinical trials and meta-analyses of patients at low risk for cardiac complications during exercise indicated that exercise training after myocardial infarction results in (a) 20%–25% improvement in functional capacity, (b) fewer anginal symptoms, (c) 24% reduction in all-cause mortality, (d) 25% reduction in cardiovascular mortality (Jolliffe et al., 2004; O’Connor, et al., 1989; Oldridge, Guyatt, Fischer, & Rimm, 1988; Oldridge et al., 1991; Taylor et al., 2004), and (e) enhanced quality of life (Arthur, Smith, Kodis, & McKelvie, 2002). The Cardiac Rehabilitation Guidelines (Wenger et al., 1995) called for universal application of medically supervised exercise for the more than 12 million patients with established CHD. Despite the well-established benefits and safety of CR, only about 11%–20% of eligible patients actually participate (Mark et al., 1994; Wenger et al.). Although more recent studies (Blackburn et al., 2000; Evenson, Rosamond, & Luepker, 1998) have found slightly higher enrollment rates of up to 50%, CR services are still significantly underutilized. Thus, alternative methods of delivering CR are needed that can reach more patients yet are comparable in their effectiveness.
A growing body of literature has documented the potential for similar effects of programs consisting of either home-based exercise programs (Ades et al., 2000; DeBusk et al., 1985; Hands et al., 1987; Heath, Maloney, & Fure, 1987; Miller, Haskell, Berra, & DeBusk, 1984; Sparks, Shaw, Eddy, Hanigosky, & Vantrese, 1993; Squires, Miller, Harn, Micheels, & Palma, 1991; Stevens & Hanson, 1984) or multifactorial risk reduction programs (Arthur et al., 2002; Carlson, Johnson, Franklin, & VanderLaan, 2000; DeBusk et al., 1994; Haskell et al., 1994; Taylor, Miller, Smith, & DeBusk, 1997) in delivering CR services. Seven studies yielded the findings of no significant differences between home-based and group-based programs in increasing functional capacity (Arthur et al.; DeBusk et al., 1985; Hands et al.; Heath et al.; Miller et al.; Sparks et al.; Stevens & Hanson). In addition, no group differences were found in exercise-related ischemia, arrhythmias and training-related complications (Ades et al.; DeBusk et al., 1985). Only one study (Heath et al.) found that patients in structured CR improved significantly more than the home-based exercise group.
Five studies were found that incorporated multiple risk factor modification as in the current study (Ades et al., 2000; Arthur et al., 2002; Carlson et al., 2000; DeBusk et al., 1994; Haskell et al., 1994). In two of these studies, the home-based risk reduction program, provided within a nurse-case-manager model, was more effective than usual medical care in reducing low density lipoprotein cholesterol, improving functional capacity, and increasing smoking cessation (DeBusk et al., 1994; Haskell et al.). Although landmark studies, the comparison group in these studies was usual medical care, which typically devotes minimal attention to secondary prevention strategies. In the other three studies, multiple risk reduction using a home-based or modified home-based protocol was compared with traditional-CR (trad-CR) efforts (Ades et al.; Arthur et al.) Carlson et al. (2000) found that patients in a modified protocol group had higher rates of exercise over the 6-month study period, lower program costs ($738 less on average), and no significant group differences in cardiovascular outcomes. However, these patients still attended 1 month of trad-CR. Ades et al. compared transtelephonically monitored home-based CR (home-CR) with trad-CR and found that patients in the home-based group increased peak aerobic capacity to a similar extent as patients in trad-CR. Arthur et al. (2002) compared 6 months of monitored, home-based exercise training, with traditional CR and found that peak VO2 improved significantly in both groups (36% in trad-CR and 31% in home-CR). In contrast, the home-CR group demonstrated better improvement in health-related quality of life by 6 months compared to the trad-CR group.
There is a critical need to test alternative methods of delivering CR services, using more appropriate research designs such as non-inferiority or equivalency designs. All of these earlier trials were designed as difference (or superiority) studies resulting in analytic techniques that were less than optimal for a goal of establishing non-inferiority of an alternate program. Non-inferiority clinical trials are used when there is an existing treatment that is considered the “gold” standard (trad-CR) and the investigator wants to compare a new intervention (in this case home-CR) with the gold standard. In addition, few studies examined the effects of alternative CR services that were delivered within the same timeframe as trad-CR, as proposed here. The study was designed as a non-inferiority study whereby the goal was to demonstrate whether a home-CR program was at least as effective as trad-CR in the modification of coronary heart disease risk factor indicators (body mass index [BMI], waist circumference, frequency of aerobic exercise, blood pressure, low fat diet, cholesterol, frequency of anger, and smoking) from the beginning of cardiac rehabilitation (baseline) to 2 and 4 months later.
Design and Sample
A repeated measures quasi-experimental design was used to compare risk-factor outcomes between home-CR and trad-CR groups. The setting for the study was a 157-bed hospital in a rural community in the Midwest. Hospital-based CR programs in two adjacent rural communities also served as clinical sites for participant recruitment. Included patients were: (1) older than 35 years of age, (2) able to speak and read English, and (3) without a history of psychiatric illness by self-report. All participants who were eligible for CR (diagnosed with myocardial infarction, undergoing percutaneous coronary intervention or coronary artery bypass graft surgery) and who met study criteria were invited to participate at the time of hospital discharge. Of the 74 who were initially enrolled, 12 persons withdrew during the course of the study, indicating a 16% attrition rate. The final sample consisted of 62 participants. No differences were found between participants who remained in the study and those who withdrew in sociodemographic, illness, and risk factor variables. Approximately the same proportion of participants in both programs dropped out of the study (12% in the trad-CR group and 11% in the home-CR group; χ2  = 0.010, p = .92). After obtaining informed consent, participants selected which type of cardiac rehabilitation to participate in, either home-CR or trad-CR programs. Because of fiscal constraints at the clinical sites, participants were unable to be randomly assigned to groups.
Both CR programs included the core components recommended by the American Association of Cardiovascular and Pulmonary Rehabilitation [AACVPR] (2004). In the trad-CR program, the exercise component consisted of 24 exercise training sessions, 3 times per week over 8 weeks. The exercise program was individualized for the patient based on the type of exercise they preferred, their exercise equipment at home, and any job-related needs (upper arm work) of the patient. They were also encouraged to exercise on their own outside of trad-CR up to 5–6 times per week. Patients were also provided with educational sessions on various topics such as benefits of exercise, creative cooking, and medications.
The home-CR intervention was based on social cognitive learning theory (Bandura, 1997). This theory proposes that greater self-efficacy is associated with a higher expectation that the person can produce the desired outcome. Beliefs about self-efficacy develop mainly from successful goal attainment and verbal persuasion, particularly by those in authority with special knowledge. In this framework, patients were taught how to (1) self-monitor the health habits they wanted to change, (2) set attainable subgoals to motivate and direct their efforts, and (3) focus on relapse management efforts needed to succeed. Participants in home-CR participated in two structured counseling/educational sessions in an outpatient setting but executed the program at home. The first session was 2–3 weeks after hospital discharge to coincide with the initiation of trad-CR and the second session 8 weeks later to correspond with the completion of trad-CR. Both sessions consisted of individualized counseling provided by a cardiac rehabilitation clinical nurse specialist about risk factor modification and medications (45 minutes), and a monitored exercise session followed by an exercise prescription with (30 minutes), and a dietitian provided low-fat dietary counseling (45 minutes). The target duration of exercise was 30 min, 5 or more times per week. One telephone call was made during the 8-week program to monitor the progress of patients in the home-CR group, and to provide positive reinforcement.
All study instruments were completed through mailed surveys at baseline, and 2 and 4 months. Body Mass Index (BMI) was calculated using the standard formula from self-report of height and weight; weight was asked at each time point. Normal BMI is < 25.0 kg/m2. Overweight is defined as a BMI of 25.0 to 29.9 kg/m2 and obesity as a BMI > 30.0 (AACVPR, 2004). Participants were asked to measure their waist at each data collection point.
Additional cardiac risk factors were measured by selected questions from the Arizona Heart Institute and Foundation Heart Test for Men and Women (Diethrich, 1981). These questions have face validity and the literature supports the relevance of measuring these variables as outcomes of CR. Participants were asked about (1) blood pressure the last time it was taken; (2) whether they engaged in any aerobic activity, such as brisk walking, jogging, bicycling, or swimming, for more than 20 minutes; (3) most recent cholesterol level; (4) amount of fat in diet; and (5) how often they were easily angered and frustrated. Change scores were computed based on each participant’s actual improvement or worsening for each risk factor variable (see Table 1). In addition, participants were asked whether they were still smoking (yes/no); however, because of the few participants who were still smoking, these data were not analyzed statistically.
To test that home-CR was at least as effective as trad-CR in risk factor modification, non-inferiority testing using one-sided testing was used. In difference (superiority) testing, the assumption of equivalence between groups is justified when (1 – a) confidence intervals for the difference between the two group means includes zero. A presumption of no difference is based on failure to find a difference. This, however, is not proof of non-inferiority (Barker, Luman, McCauley, & Chu, 2002). Interval data were analyzed first. Using a repeated measures analysis of covariance, the 95% confidence interval for the difference in means between the two treatments for BMI and waist values was calculated at month 2 and 4, after adjustment for the baseline BMI or waist levels. Based on various research studies on the choice of the (delta) non-inferiority limit, the limit for the interval variables (BMI and waist) was chosen to be 5% of the respective mean baseline values across all patients (Gomberg-Maitland, Frison, & Halperin, 2003). Average non-inferiority is established and the home-CR program is considered at least as effective as the trad-CR program at a 5% level of confidence if the upper limit of 95% confidence interval fell at the left of delta, the non-inferiority limit (5% of the mean baseline values).
For the ordinal outcome variables, a nonparametric rank test based on the Wilcoxon-Mann-Whitney U effect was used to establish the non-inferiority of the home-CR group (Munzel & Hauschke, 2003). The average non-inferiority is established if the 95% confidence interval, based on Wilcoxon-Mann-Whitney U effect, falls completely within the interval (0.5-delta, 1) where delta = 0.2 is the predefined non-inferiority limit. The home-CR program was considered to be at least as effective as the trad-CR program if the 95% confidence interval was completely contained in 0.3, 1 meaning, the probability that the trad-CR group tends to show a worsening or no change relative to the home-CR group is at least 0.30.
Baseline demographic, illness, and risk factor characteristics are reported in Table 2. Participants in both groups were, on average, 63 years old, Caucasian, married, and had a high school education or higher. Approximately one-third of the participants were women and about one-half were employed. There were no significant differences between groups in the demographic variables using t test and chi-square analyses except for annual income. A significantly larger proportion of trad-CR participants (66%) reported an annual income higher than $20,000 compared to home-CR participants (38%) (χ2  = 4.58, p = .03). In relation to illness characteristics, about two-thirds of the participants in both groups reported having a prior myocardial infarction.
At baseline, 76% of participants in the trad-CR group and 75% in the home-CR group had a BMI > 25 kg/m2 (see Table 2). Similarly, 42% in the trad-CR group and 38% in the home-CR group had waist measurements that placed them at higher risk (i.e., women > 35 inches and men > 40 inches). The majority of participants in both groups reported blood pressure <140/90, about 40% were engaging in aerobic exercise > 20 minutes ≥ 3 times per week, less than half of the participants in both groups reported their cholesterol level < 200 mg/dL, 50% reported eating a low fat diet, and 53% of trad-CR patients and 33% of home-CR patients reported that they were rarely angry.
The difference between groups in mean BMI and waist circumference is shown in Table 3. The upper bound 95% non-inferiority one-sided confidence limit was below the preset non-inferiority limit for both BMI and waist at 2 months and 4 months indicating that the home-CR group was as least as effective as trad-CR group in achieving BMI and waist circumference outcomes.
The improvement over time in both groups in the proportion of participants who were making risk factor modifications in blood pressure, aerobic exercise, cholesterol level, amount of fat in diet, and frequency of anger is shown in Table 4. Similar improvement was found in both groups. The lower-bound of the one-sided 95% confidence interval was above 0.3 for all variables except anger indicating non-inferiority of home-CR compared with trad-CR. These results suggest that home-CR was at least as effective as trad-CR in helping patients achieve risk factor modification outcomes. However, in relation to anger, the home-CR group was not found to be as effective as the trad-CR group. The proportions of smokers were similar in the home-CR group (4%) and the trad-CR group (11%) and did not change much over time.
The home-CR group was at least as effective as the trad-CR group in attaining CHD risk factor modifications of BMI, waist measurement, blood pressure, frequency of aerobic exercise, cholesterol, and a low fat diet. Findings are similar to efficacy of home-CR in comparison with trad-CR on selective CR components with improvement or maintenance reported in cholesterol levels (Carlson et al., 2000; Gordon et al., 2002; Gordon & Haskell, 1997), body weight (Arthur et al., 2002; Carlson et al., 2000; Gordon et al.), blood pressure (Carlson et al.), waist circumference (Arthur et al.), physical activity levels (Ades et al., 2000; DeBusk et al., 1985; Heath et al., 1987), and dietary fat intake (Gordon & Haskell) through a home-based program. The difference between this and earlier studies is the noninferiority design that was used to examine groups. This is a better design for demonstrating that the home-CR intervention was very close to or at least as effective as trad-CR, the current standard-of-care for delivering CR services. This study was unable to demonstrate that the home-CR group was as effective as the trad-CR group in reducing the frequency of anger, therefore more study is needed in this area.
This method of delivering CR is not intended to supplant existing trad-CR efforts, but to provide a tested method of delivering services for those patients who are unable to attend trad-CR. Previous studies found that patients did not participate in CR because of several barriers including work and time limitations, economical and geographic access issues, scheduling problems, and lack of health insurance (Fleury, Lee, Matteson, & Belyea, 2004). In addition, it might help increase the CR participation rates in women as they are typically underrepresented in CR programs (Fleury et al.). The availability of home-CR presents healthcare consumers with an option, wherein rehabilitation may be individually tailored to become compatible to lifestyle, preferences, and socio-economic factors, thus augmenting limitations of traditional programs found in previous studies (Filip, McGillen, & Mosca, 1999; Womack, 2003).
Of the home-CR programs that have been tested, they are wide-ranging in scope, length, and structure. They varied in length from 3 months (Ades et al., 2000) to 6 months (Arthur et al., 2002; Gordon et al., 2002) or longer (DeBusk et al., 1985; Haskell et al., 1994). One method provided 1 month of structured cardiac rehabilitation and then gradually transitioned to home-CR (Carlson et al., 2000). Some provided 3-times-weekly scheduled exercise sessions in the home connected transtelephonically (Ades et al.; Squires et al., 1991), and others provided education and counseling sessions at the beginning of CR with follow-up telephone calls (Arthur et al.) similar to the current study. The number and type of in-person and telephone contacts that are required to bring about positive outcomes has also varied between studies and has not been well established. This study’s cardiac rehabilitation protocol was delivered over an 8-week time frame that corresponded to current CR program length and insurance reimbursement. Additional studies are needed to determine the optimum “dose” of delivering alternate CR services that results in the best short- and long-term outcomes.
About the same proportion of participants who smoked at the beginning of CR continued to smoke in both the trad-CR and home-CR groups. In trad-CR, there were four smokers (11%) at baseline and 4 months. One participant in trad-CR quit smoking but another person started smoking again. In home-CR, one participant smoked at baseline and continued to smoke throughout the study. The overall proportion of participants who were smoking in the current study (8%) was similar to the proportion of smokers in earlier studies (6%–12%; Jolliffe et al., 2004; Yates, Braklow-Whitton, & Agrawal, 2003). The current study was designed as a minimal intervention smoking cessation program that included education on smoking cessation as part of a comprehensive risk-factor modification program. Greater success rates may be achieved with a more intensive smoking cessation program.
There were several limitations in the study. Because all of the participants were Caucasian and resided in a rural, Midwestern community, the generalizability of the findings is limited to this population. The trad-CR group reported significantly higher income than patients in the home-CR group, which may have been why those patients could afford to attend trad-CR. This difference, in turn, may have affected the study findings in some unknown way. In addition, allowing participants to choose which group to be in potentially affects the internal validity of the study. That is, the participants might have done equally well because they chose the group that best suited them and group equality may have been because of this factor. Another limitation was that we relied on patients’ self-report of risk factor modification. Further research involving more diverse participants, larger samples, objective measures to verify patients’ self-report, longer follow-up to evaluate long-term adherence, and random assignment to groups is necessary to broaden and strengthen the results of this study. To build on the current study, investigators might examine whether a home-CR intervention, compared with trad-CR, is equally effective for both men and women and persons of other racial and ethnic backgrounds in relation to short- and long-term cardiovascular risk outcomes. It is also important to examine the specific components of CR (i.e., self-efficacy, adherence to lifestyle changes, etc.) that result in improved outcomes. Finally, a cost effectiveness study is needed to ensure that both programs provide efficient and cost-effective services for participants.
Results indicate that a home-CR program is at least as effective as a traditional, institution-based CR program in achieving improvements in CHD risk factor modifications of BMI, waist measurement, blood pressure, frequency of aerobic exercise, cholesterol, and a low fat diet. These findings do not discount traditional programs, but rather offer a viable alternative method of delivering CR services that can overcome the current barriers of care delivery, provide access to more patients, and still result in high quality rehabilitation outcomes for cardiovascular patients.
This study was funded in part by a grant from the University of Nebraska Medical Center Outcomes Grant Program.
About the Authors
Bernice C. Yates, PhD RN, is associate dean for research and associate professor at the University of Nebraska Medical Center, College of Nursing. Direct correspondence to her at University of Nebraska Medical Center, College of Nursing, 985330 Nebraska Medical Center, Omaha, NE, 68198 or firstname.lastname@example.org.
Birgit M. Heeren, MSN RN CCRN, is a nurse practitioner for pulmonary and sleep consultants, Sioux Falls, SD.
Sev M. Keller, MSN APRN, is a nurse practitioner for MidAmerica Cardiovascular Institute, Omaha, NE.
Sangeeta Agrawal, MSc, is a research analyst at the University of Nebraska Medical Center, Department of Preventive and Societal Medicine.
Julie A. Stoner, PhD, is associate professor of biostatistics at the University of Nebraska Medical Center, Department of Preventive and Societal Medicine.
Carol Ott, PhD RN, is associate professor at the University of Nebraska Medical Center College of Nursing, Kearney Division.
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