CLINICAL EFFECTIVENESS OF A COMMUNITY-BASED CARDIOVASCULAR RISK REDUCTION PROGRAM IN PARTICIPANTS WITH VERSUS WITHOUT DIABETES
Susan Pickel, Sheldon Warman, MD; Brenda Mitchell, PhD; Ivan Levinrad, RPT; Richard Leighton, MD; Carla English, MHS; Richard Salmon, DDS; Barry Franklin, PhD; Neil Gordon, MD; North Broward Hospital District and INTERxVENT Coordinating Center
Diabetes is a major contributor to cardiovascular disease (CVD) morbidity and mortality. Previous studies have documented the clinical effectiveness of the INTERxVENT Lifestyle Management and Cardiovascular Risk Reduction Program (INTERxVENT) in healthy persons and persons with CVD. In this study, we compared the effect of approximately 1 year of participation in INTERxVENT on multiple CVD risk factors in 2316 consecutive participants with (n = 258) and without (n = 2058) diabetes. Lifestyle management interventions included exercise training, correct nutrition, weight management, stress management, and smoking cessation. Participants were referred to their personal physicians for consideration of medication changes in accordance with national clinical guidelines.
Fasting blood glucose decreased by 15 mg/dL (P < .05) in participants with diabetes and remained essentially unaltered in participants without diabetes (P < .05 for participants with versus without diabetes). For participants with abnormal baseline values for other CVD risk factors, improvements (P < .05) were observed for participants with and without diabetes, as follows: total cholesterol (diabetes -33 mg/dL, no diabetes -29 mg/dL); LDL cholesterol (diabetes -11 mg/dL, no diabetes -17 mg/dL); HDL cholesterol (diabetes 5 mg/dL, no diabetes 4 mg/dL); triglycerides (diabetes -35 mg/dL, no diabetes -35 mg/dL); systolic/diastolic BP (diabetes -14/-11 mm Hg, no diabetes -18/-10 mm Hg) and weight (diabetes -3.0 lbs, no diabetes -2.5 lbs). With the exception of systolic BP (which decreased to a greater degree in participants without versus with diabetes, P < .05), no other statistically significant differences were observed for participants with diabetes compared to participants without diabetes. In participants without coronary heart disease, the calculated Framingham 10-year coronary heart disease risk score decreased by 15.3% (P < .05) in participants with diabetes and by 23.7% (P < .05) in participants without diabetes (P = NS for participants with versus without diabetes). These data serve to document the similar clinical effectiveness of INTERxVENT in persons with and without diabetes.
IMPACT OF PROGRAM DURATION AND CONTACT FREQUENCY ON EFFICACY OF CARDIAC REHABILITATION
Robert D. Reid, PhD; William A. Dafoe, MD; Neil B. Oldridge, PhD; Louise Morrin, BSc, PT; Alain Mayhew, MSc, PT; University of Ottawa Heart Institute, Ottawa, Canada
Rationale:
Cardiac rehabilitation programs (CRP) are known to have beneficial effects on functional capacity, coronary risk factors, psychological distress, and health-related quality of life. Optimum program duration and intensity, however, has not been determined.
Objective:
This study compared the efficacy of an intensive (3-month, 33-session) versus a distributed (12-month, 33-session) CRP, 3 months and 1 year after program intake.
Methods:
388 patients with coronary artery disease (mean age 57.9 +/- 10.9 years, 84.1% male) were randomly assigned to either an intensive (n = 196) or a distributed (n = 192) multi-factorial CRP. The 3-month group attended twice weekly and the 12-month group once a week for 14 weeks, once every 2 weeks for 14 weeks, and once a month for 24 weeks. Outcomes measured at baseline, 3 months, and 1 year included program adherence, functional capacity (treadmill testing), LDL-cholesterol, perceived stress (Perceived Stress Scale), disease-specific quality of life (MacNew Quality of Life After MI), and generic health-related quality of life (SF-36). Between-group scores for each variable at each time point were compared using analysis of covariance with the baseline value of the variable used as a covariate.
Results:
Adherence to prescribed sessions was 78% in the 3-month group and 76% in the 12-month group. Mean +/- SD for outcomes adjusted for baseline values of the same variable are shown in the Table. At 1 year, participants assigned to a 12-month CRP reported lower levels of perceived stress compared to 3-month CRP participants. There were no differences for adherence, functional capacity, LDL-cholesterol, or quality of life.
Conclusion:
A 3-month intensive CRP has similar effects to a 12-month distributed CRP for most key program outcomes. Patient preference may determine optimal duration and frequency of contact.
QUALITY-OF-LIFE CHANGES AFTER 24 WEEKS PARTICIPATION IN NORTH CAROLINA PULMONARY REHABILITATION PROGRAMS
D. Verrill, M. Lippard, NorthEast Medical Center, Concord, NC; W. Beasley, C. Barton, Davidson College Psychology Department, Davidson, NC.
Rationale:
There are conflicting reports on the benefits of long-term pulmonary rehabilitation (PR) therapy on quality of life (QOL) for patients with pulmonary diseases.
Objective:
To determine the effect of long-term (24-week) PR on QOL measures in North Carolina PR participants.
Methods:
Fifty-two patients (22 men, 30 women) from four hospital PR programs completed Ferrans & Powers Quality of Life Index Pulmonary Version (QOLI) and SF-36 health surveys prior to PR entry and again after 12 weeks and 24 weeks of participation. Overall QOLI scores and SF-36 Physical (P) and Mental (M) component summary scores were compared at each time period with repeated measures analysis of variance. Mean score differences were assessed with post hoc paired samples t tests.
Results:
The survey results for men and women (mean +/- SD) are summarized in the Table. Improvements in physical and mental QOL parameters were observed at 12 weeks in both men and women, with the exception of the SF-36 M scores in women and the QOLI scores in men, which approached significance. All QOL parameters improved by 24 weeks, with the exception of the SF-36 M scores in women. Only the men's QOLI scores improved from 12 weeks to 24 weeks.
Conclusion:
Overall improvements in QOL parameters were seen after 12 weeks of PR participation. Most scores then plateaued with longer-term PR participation. Further study over longer time periods with a greater number of subjects and a control group may provide better insight into the psychosocial adaptations associated with long-term PR.
CLINICAL EFFECTIVENESS OF A COMMUNITY-BASED CARDIOVASCULAR RISK REDUCTION PROGRAM IN AFRICAN AMERICANS VERSUS CAUCASIANS
Carlye Barat, MS; Carla English, MHS; Susan Pickel, BSN, MHM; Sheldon Warman, MD; Richard Salmon, DDS; Linda Hall, PhD; Barry Franklin, PhD; Neil Gordon, MD; North Broward Hospital District and INTERxVENT Coordinating Center
Since the mid-1980s, coronary heart disease (CHD) mortality rates have declined more slowly in African Americans than in Caucasians in the United States. In this study, we compared the clinical effectiveness of a community-based lifestyle management and cardiovascular risk reduction program (INTERxVENT) in African American (n = 701) and Caucasian (n = 1461) participants. Subjects were evaluated at baseline and after approximately 1 year of participation in the INTERxVENT program. Lifestyle management interventions included exercise training, correct nutrition, weight management, stress management, and smoking cessation. Participants were referred to their personal physicians for consideration of medication changes in accordance with national clinical guidelines.
For participants with abnormal baseline CVD risk factors (based on national clinical guidelines), clinically relevant improvements (P < .05) were observed for multiple variables in African Americans and Caucasians, as follows: total cholesterol (African Americans -20 mg/dL, Caucasians -32 mg/dL); LDL cholesterol (African Americans -11 mg/dL, Caucasians -19 mg/dL); HDL cholesterol (African Americans 6 mg/dL, Caucasians 4 mg/dL); triglycerides (African Americans -52 mg/dL, Caucasians -31 mg/dL); fasting glucose (African Americans, -32 mg/dl; Caucasians, -26 mg/dl); systolic/diastolic BP (African Americans -17/-10 mm Hg, Caucasians -17/-11 mm Hg) and weight (African Americans -1.6 lbs, Caucasians -5.1 lbs). Total cholesterol, LDL cholesterol, and weight decreased to a greater degree (P < .05) in Caucasians as compared with African Americans. Moreover, in participants without CHD, the calculated Framingham 10-year CHD risk score decreased to a greater degree (P < .05) in Caucasians (22.9% decrease P < .05) as compared with African Americans (14.2% decrease P < .05). These data indicate that while African Americans and Caucasians both benefit substantially from INTERxVENT, the magnitude of benefit may be greater for Caucasian participants.
A COMPREHENSIVE CARDIOVASCULAR DISEASE RISK REDUCTION PROGRAM THAT INCLUDES A LOW-FAT, HIGH-COMPLEX CARBOHYDRATE DIET IS BENEFICIAL IN INDIVIDUALS WITH HYPERTRIGLYCERIDEMIA
Neil Gordon; Richard Salmon, DDS; Carla English, MHS; William Saxon, ASRT; Richard Leighton, MD; William Dafoe, MD; Barry Franklin, PhD; St. Joseph's/Candler Health System and INTERxVENT Coordinating Center
The clinical effectiveness of a low-fat, high-complex carbohydrate diet in individuals with hypertriglyceridemia is controversial. In this study, we investigated the clinical effectiveness of a comprehensive cardiovascular disease (CVD) risk reduction program that includes a low fat (approximately 20% of daily calories)/high complex carbohydrate (approximately 50%-60% of daily calories) diet in 2424 individuals with (n = 429) and without (n = 1995) hypertriglyceridemia (that is, baseline fasting serum triglycerides > 199 mg/dL). Testing was conducted at baseline and after approximately 12 weeks of intervention. Fasting serum triglycerides decreased by 66 mg/dL (P < .05) in individuals with baseline hypertriglyceridemia (baseline value = 291 mg/dL) and increased by 3 mg/dL (P = NS) in individuals without baseline hypertriglyceridemia (baseline value = 118 mg/dL). For individuals with abnormal baseline values for other CVD risk factors, significant (P < .05) improvements were observed in both groups as follows: total cholesterol (hypertriglyceridemia -45 mg/dL, no hypertriglyceridemia -28 mg/dL); LDL cholesterol (hypertriglyceridemia -28 mg/dL, no hypertriglyceridemia -19 mg/dL); HDL cholesterol (hypertriglyceridemia 3 mg/dL, no hypertriglyceridemia 3 mg/dL); fasting glucose (hypertriglyceridemia -42 mg/dL, no hypertriglyceridemia -22 mg/dL); systolic/diastolic blood pressure (hypertriglyceridemia -15/-10 mm Hg, no hypertriglyceridemia -16/-10 mm Hg); and weight (hypertriglyceridemia -5 lbs, no hypertriglyceridemia -4 lbs). These data demonstrate that when a low-fat, high-complex carbohydrate diet is administered as part of a comprehensive CVD risk reduction program, individuals with and without baseline hypertriglyceridemia derive substantial improvements in multiple risk factors.
EFFECT OF PERCEIVED HEALTH STATUS ON CLINICAL OUTCOMES IN PARTICIPANTS IN A CONTEMPORARY PHASE 2 CARDIAC REHABILITATION PROGRAM
Jana Webb, BS; Linda Hall, PhD; Richard Salmon, DDS; Carla English, MHS; Barry Franklin, PhD; Neil Gordon, MD; Forrest General Hospital and INTERxVENT Coordinating Center
The effect of perceived health status on cardiac rehabilitation (CR) clinical outcomes has yet to be fully elucidated. To clarify the situation further, in this multicenter study we compared the effect of a contemporary phase 2 CR program on multiple CVD risk factors in patients who rated their health as fair or poor on program entry (group A, n = 251) and those who rated their health as good, very good, or excellent (group B, n = 549) at program entry. Risk factors were evaluated at baseline and after an average of approximately 90 days of participation in a phase 2 CR program at 12 centers in the United States. On exit from the phase 2 CR program, improvements in multiple CVD risk factors were observed for participants in both groups who had abnormal baseline risk factor values (based on national clinical guidelines), as follows (P < .05 unless otherwise indicated): total cholesterol (group A -47 mg/dL, group B -39 mg/dL); LDL cholesterol (group A -26 mg/dL, group B -31 mg/dL); HDL cholesterol (group A 4 mg/dL, group B 4 mg/dL); triglycerides (group A -63 mg/dL, group B -27 mg/dL, P = NS); fasting glucose (group A -45 mg/dL, group B -28 mg/dL); systolic/diastolic BP (group A -24/-19 mm Hg, group B -18/-16 mm Hg); and weight (group A -2.4 lbs, group B -1.8 lbs). With the exception of systolic BP (which decreased to a greater degree in group A versus group B, P < .05), no other statistically significant differences were observed for group A as compared with group B. These data indicate that patients who rate their health as fair or poor on entry into a phase 2 CR program derive similar improvements in multiple CVD risk factors as compared with patients with a more favorable perceived health status.
PREDICTORS OF EXERCISE MAINTENANCE 6 MONTHS AFTER CARDIAC REHABILITATION
Shirley M. Moore, RN, PhD; Jacqueline M. Charvat, BS; Beverly L. Roberts, RN, PhD; Case Western Reserve University; Paul Ribisl, PhD; Case Western Reserve University; Wake Forest University
Rationale and Objectives:
Exercise maintenance after cardiac rehabilitation (CR) remains problematic. The purpose of this study was to determine predictors of exercise maintenance 6 months after CR.
Methods:
In this prospective longitudinal study, a convenience sample of 94 individuals (30 women; 64 men) was followed for 6 months after CR. Dependent exercise variables were: exercise frequency, exercise amount (number of hours exercised), and intensity (percent of time in target heart rate [THR] zone). Candidate predictor variables were physical variables (age, race, comorbidity, cardiac functional status, fitness, muscle and joint pain, leg pain, anginal pain, abdominal girth); psychosocial variables (social support, marital status, depression); and cognitive variables (exercise benefits/barriers, self-efficacy, motivation, problem solving). At completion of CR, data on predictor variables were collected in a 45-minute interview and portable wristwatch heart rate monitors were worn during exercise for 6 months.
Results and Conclusions:
Fourteen individuals (15%) did no exercise after CR. Subjects averaged 53 exercise sessions over 24 weeks, ranging from 0 to 168. The mean number of hours exercised was 47 (SD 42, range 0-186). Subjects exercised within their THR zone 32% of the time. When exercise frequency was regressed on the predictor variables, the model was significant (F[6,87] = 6.1;P = .000), with exercise self-efficacy and fitness being the major independent predictors. The model for exercise amount was significant (F[4,89] = 7.0;P = .000), with predictors being self-efficacy (t = 32.5;P = .014) and race (t = 2.3;P = .03). The model for percent of time in THR zone was significant (F[3,76] = 4.3;P = .007), with predictors being self-efficacy (t = 2.7;P = .009) and exercise barriers (t = -2.546, P = .013). Thus, different dimensions of exercise behavior were predicted by different factors, suggesting that different interventions may be needed to address specific dimensions of exercise maintenance. Self-efficacy clearly is a dominant factor.
THE CALIFORNIA PULMONARY REHABILITATION COLLABORATIVE PROJECT (CPRCP)
Herbert J. Yue, MD; Lela M. Prewitt; David H. Kupferberg; Andrew L. Ries; on behalf of the CPRCP Research Group, University of California, San Diego.
Rationale:
Most studies evaluating the benefits of pulmonary rehabilitation are limited to small patient populations in a few selected centers.
Objective:
Evaluate the effectiveness of pulmonary rehabilitation (PR) in a collaborative study involving 10 programs in California.
Methods:
Following a common clinical program evaluation protocol, we examined changes in health-related quality of life (HRQOL), dyspnea, and healthcare utilization in patients with chronic lung disease before and up to 18 months after PR. 542 patients were enrolled; 415 in eight centers were included in final analyses (age = 68.3 +/- 9.0 SD years). Subjects completed the RAND(SF)-36 (MCS = mental component score), PCS = physical component score), UCSD Shortness of Breath (SOBQ), and UCSD Health Care Utilization questionnaires before and immediately after rehabilitation, and 3, 6, 12, and 18 months later. Baseline measures of lung function (FEV1, FVC, FEV1/FVC) and 6-minute walk (6MW) distance also were obtained.
Results:
Mean +/- SD for all patients indicated moderate-severe lung disease and respiratory impairment (FEV1 = 1.14 +/- 0.51 L [44% pred]; FVC = 2.40 +/- 0.83 L [70% pred]; 6MW distance = 345 +/- 125 m; PCS = 31.3 +/- 8.1; MCS = 48.2 +/- 11.3; SOBQ = 55.7 +/- 21.6). There were no significant differences among test centers in FEV1, but there were differences for FVC, FEV1/FVC, and 6MW. After rehabilitation, there were significant improvements in HRQOL (MCS = +3.6 +/- 9.6; PCS = +2.8 +/- 7.4) and dyspnea (SOBQ = -6.6 +/- 14.1) that diminished after 3 months but persisted up to 12 months after rehabilitation. Significant decreases were observed in hospital days, physician visits, urgent care visits, and healthcare telephone calls.
Conclusion:
We conclude that PR, as practiced in a variety of clinical programs, is effective in improving quality of life, dyspnea, and exercise tolerance, and reducing healthcare utilization in patients with chronic lung disease.