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April 7, 2009


JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives of Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.

THIS WEEK'S CONTENTS

JAMA NEWS RELEASES

(Embargoed for Release: 3 p.m. CT Tuesday, April 7, 2009)

>   Studies Indicate Exercise Training May Provide Some Benefit for Patients With Heart Failure

>   Cognitive Behavior Therapy Helps Older Adults With Anxiety Reduce Worry, Improve Mental Health

JAMA REPORT (VIDEO SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   REGULAR EXERCISE COULD HELP MILLIONS OF PEOPLE WITH HEART FAILURE LEAD HEALTHIER, HAPPIER LIVES


INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.


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SAVE THE DATE: JAMA will present new research from a theme issue on Diabetes at a media briefing on Tuesday, April 14, from 10 a.m. – 12:15 p.m., at the National Press Club in Washington, D.C. To register, go to www.jamamedia.org and click on the Events tab, or call 312-464-JAMA. Program information will be included in a future email.


TV Note: This week's JAMA Report video is on the outcomes of exercise training for patients with heart failure. The report will be fed Tuesday, April 7, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 28 (C-Band), Transponder 19, downlink frequency: 4080 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.


Please Note: The FOR THE MEDIA website now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org


EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, April 7, 2009
Media Advisory: To contact Christopher M. O'Connor, M.D., or Kathryn E. Flynn, Ph.D., call Michelle Gailiun at 919-660-1306 or email michelle.gailiun{at}duke.edu.

Studies Indicate Exercise Training May Provide Some Benefit for Patients With Heart Failure

CHICAGO—Aerobic exercise training appears safe for patients with heart failure and was associated with a modest reduction in the risk of death and hospitalization, with some improvement in quality of life, according to two articles in the April 8 issue of JAMA.

Heart failure is a major and increasingly common cardiovascular syndrome, and is the end result of many cardiovascular disorders. In the United States, an estimated 5 million patients have heart failure and an additional 500,000 new cases are diagnosed annually. Many patients treated with drug and device therapies often still have breathing difficulties and fatigue, diminished exercise tolerance, reduced quality of life, recurrent hospitalizations and premature death, according to background information in the article. Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure, but there have remained concerns regarding safety and uncertainty about clinical outcomes.

Christopher M. O'Connor, M.D., of Duke University School of Medicine, Durham, N.C., and colleagues working with Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION), examined whether aerobic-type exercise training reduces all-cause death or all-cause hospitalization in patients with medically stable chronic heart failure due to systolic dysfunction (impaired contraction of the heart). Patients in the study (n = 2,331; median [midpoint] age, 59 years) were randomized to usual care plus aerobic exercise training (that consisted of 36 sessions of supervised aerobic exercise training [walking, treadmill or stationary cycling] three times per week followed by prescribed home-based training at the same intensity 5 times per week) or usual care alone (that included optimal medical therapy and a recommendation for regular physical activity). Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. Median follow-up was 30 months.

During follow-up, 759 patients in the exercise training group (65 percent) and 796 patients in the usual care group (68 percent) died or were hospitalized. In the primary analysis, exercise training resulted in a nonsignificant reduction in the primary end point of all-cause death or hospitalization. There was no significant difference in the number of deaths in the exercise training group (16 percent) vs. in the usual care group (17 percent). Exercise training had a nonsignificant reduction in the combined end point of cardiovascular death or cardiovascular hospitalization in the main analysis in the exercise training group (55 percent) vs. in the usual care group (58 percent). There was a nonsignificant reduction in cardiovascular death or heart failure hospitalization in the exercise training group vs. in the usual care group.

After adjusting for highly prognostic predictors of the primary end point, exercise training was found to significantly reduce the incidence of all-cause death or all-cause hospitalization by 11 percent and cardiovascular death or heart failure hospitalization by 15 percent. Other adverse events were similar between the groups.

"The change from a nonsignificant to a significant result after adjustment for strongly predictive factors is unusual in large clinical trials, but can occur when the treatment differences are close to significance. The overall interpretation of the results, then, is that this structured exercise training intervention had at best a modest effect on clinical end points in a large cohort of patients," the authors write.

"Based on the safety of exercise training and the modest reductions in clinical events..., the HF-ACTION results support a prescribed exercise training program for patients with reduced left ventricular function and heart failure symptoms in addition to evidence-based therapy," the researchers conclude.
(JAMA 2009;301[14]:1439-1450. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Exercise Training Improves Health Status of Heart Failure Patients

Patients with heart failure who participated in aerobic exercise training had modest improvements in self-reported health status compared to those patients who did not have exercise training, according to an article appearing the April 8 issue of JAMA.

Patients with heart failure often experience diminished health status, including reductions in physical and social functioning and other dimensions of health-related quality of life. "Pharmacological and device interventions and disease management programs for heart failure have provided little or modest improvements in health-related quality of life. The extent to which exercise training in addition to optimal evidence-based therapy improves patients' health status is unknown," the authors write.

Kathryn E. Flynn, Ph.D., of Duke University School of Medicine, Durham, N.C., and colleagues examined the effects of exercise training on health status among patients with heart failure who were participants of HF-ACTION. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item self-administered disease-specific survey. The KCCQ is scored from 0 to 100, with higher scores representing better health status. HF-ACTION compared scores on the KCCQ overall summary scale and key subscales (i.e., physical limitations, symptoms, quality of life and social limitations) between randomized groups. Median follow-up was 2.5 years.

At 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score compared with usual care alone. Neither group experienced significant changes in KCCQ scores after 3 months, resulting in a sustained, greater improvement overall for the exercise group. At 12 months, 53 percent of patients in the exercise training group had a clinically noticeable improvement from the beginning of the trial compared with 33 percent in the usual care group.

Results for the KCCQ subscales were similar to the results for the overall summary scale. After adjusting for the cause of heart failure, there was a significant overall treatment effect on physical limitations, symptoms, quality of life and social limitations.

"The results demonstrate that participation in an exercise training program provides a modest but statistically significant improvement in patient-reported health status compared with usual care. The clinical meaningfulness of the magnitude of average change requires further study," the authors conclude.
(JAMA 2009;301[14]:1451-1459. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.

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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, April 7, 2009
Media Advisory: To contact Melinda A. Stanley, Ph.D., call Dipali Pathak at 713-798-4712 or email pathak{at}bcm.tmc.edu.

Cognitive Behavior Therapy Helps Older Adults With Anxiety Reduce Worry, Improve Mental Health

CHICAGO—Older adults with generalized anxiety disorder who received cognitive behavior therapy had greater improvement on measures of worry, depression and mental health than patients who received usual care, according to a study in the April 8 issue of JAMA.

Generalized anxiety disorder (GAD) is common in late life, with prevalence up to 7.3 percent in the community and 11.2 percent in primary care. Late-life anxiety predicts increased physical disability, memory difficulties and decreased quality of life, according to background information in the article. Late-life anxiety is usually treated with medication, but associated risks (e.g., falls, hip fractures, memory problems) with some drugs and patient fears of adverse effects limit their usefulness. Two previous studies suggested benefits of cognitive behavior therapy (CBT) in primary care for late-life GAD, but the studies were small and the conclusions were limited. Older adults most often seek treatment for GAD in primary care.

Melinda A. Stanley, Ph.D., of the Baylor College of Medicine, Houston, and colleagues conducted the first randomized clinical trial of CBT for late-life GAD in primary care to examine whether CBT would improve outcomes relative to enhanced usual care (EUC). The trial included 134 older adults (average age, 67 years) in two primary care settings, with treatment provided for 3 months. Assessments were conducted at the beginning of the trial, posttreatment (3 months), and over 12 months of follow-up, with assessments at 6, 9, 12 and 15 months. Patients were randomized to either CBT (n = 70), which included education and awareness, relaxation training, cognitive therapy, problem-solving skills training and behavioral sleep management; or EUC (n = 64), in which patients were telephoned biweekly during the first 3 months of the study by the same therapists to provide support and ensure patient safety. Therapists reminded patients to call project staff if symptoms worsened.

Levels of anxiety, worry, depression and physical/mental health quality of life were measured via various tests or surveys. The researchers found that CBT, compared with EUC, significantly improved worry severity, depressive symptoms and general mental health. In intention-to-treat analyses, response rates defined according to worry severity were higher following CBT compared with EUC at 3 months (40.0 percent vs. 21.9 percent).

"This study is the first to suggest that CBT can be useful for managing worry and associated symptoms among older patients in primary care," the authors write. "This study paves the way for future research to test sustainable models of care in more demographically heterogeneous groups."
(JAMA 2009;301[14]:1460-1467. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.

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JAMA REPORTS

VIDEO: Windows Media | Quicktime

REGULAR EXERCISE COULD HELP MILLIONS OF PEOPLE WITH HEART FAILURE LEAD HEALTHIER, HAPPIER LIVES

INTRO:
Exercise used to be considered potentially dangerous for people with heart failure. However, two reports from a large study featured this week in JAMA confirm the safety and medical benefits of supervised exercise, and show how it can improve a patient's quality of life. Haley Weldon explains in this week's JAMA Report.

VIDEO:
B-ROLL
Patient walking into Duke Wellness Center

AUDIO:
VO:
WHEN LISE? (LEE-ZAY) COLEMAN WAS DIAGNOSED WITH HEART FAILURE, DOCTORS ORDERS WERE TO TAKE IT EASY.

VIDEO:
SOT/FULL
Super @: :05
Lise? Coleman
Has Heart Failure

AUDIO:
Runs: (:09)
They told me to do nothing, basically…they didn't want me to even lift a basket of clothes. I was scared to do anything.

VIDEO:
SOT/FULL
Super @: :14
Kathryn E. Flynn, Ph.D.
Duke Clinical Research Institute

AUDIO:
Runs: (:10)
Heart failure is a condition in which the heart is unable to pump enough blood to meet the body's needs and it affects about 5 million people in the U.S.

VIDEO:
B-ROLL
Patient walking on track

AUDIO:
VO:
LIKE MANY PATIENTS, LISE? WENT ON MEDICATION TO TRY AND CONTROL HER SYMPTOMS OF FATIGUE, SHORTNESS OF BREATH AND SWELLING IN HER LEGS – SHE ALSO EVENTUALLY ENROLLED IN HF-ACTION, THE LARGEST CLINICAL STUDY OF ITS KIND, EXAMING THE SAFETY, HEALTH AND MEDICAL EFFECTS OF EXERCISE TRAINING AMONG PATIENTS WITH MODERATE TO SEVERE HEART FAILURE.

VIDEO:
SOT/FULL
Super @: :41
Christopher M. O'Connor
Duke Clinical Research Institute
B-ROLL
Dr. O'Connor at desk

AUDIO:
Runs: (:20)
We thought what was most important was to see if we could influence keeping these patients out of the hospital whether for any cause or for heart failure and whether we could prolong their life. Equally important is quality of life. Could we improve their quality of life?

VIDEO:
B-ROLL
Dr. Flynn in a meeting
GFX/FULL
HF-ACTION
2331 Heart Failure Patients
Usual Care Group: 1,172 patients received:
optimal Heart Failure care
Exercise Group: 1,159 patients received:
optimal Heart Failure care
36 supervised exercise sessions
instructions and equipment for home-based training
GFX/FULL - JAMA Cover
B-ROLL – Patient exercising

AUDIO:
VO:
LED BY DRS. CHRISTOPHER O'CONNER AND KATHRYN FLYNN OF THE DUKE CLINICAL RESEARCH INSTITUTE, THE STUDY ENROLLED OVER 2,300 PATIENTS, DIVIDING THEM INTO A “USUAL CARE” GROUP AND AN EXERCISE GROUP, AND FOLLOWING UP WITH THEM AN AVERAGE OF 30 MONTHS. THIS RESEARCH RESULTED IN TWO REPORTS THAT ARE FEATURED THIS WEEK IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, ONE FOCUSING ON THE SAFETY AND MEDICAL BENEFITS OF EXERCISE TRAINING, THE OTHER ON ITS EFFECT ON QUALITY OF LIFE. MODEST IMPROVEMENTS WERE FOUND ACROSS THE BOARD.

VIDEO:
SOT/FULL
Christopher M. O'Connor, M.D.
Duke Clinical Research Institute

AUDIO:
Runs: (:14)
First and foremost, we showed that exercise training is safe in patients with advanced heart disease. Second, we showed a modest improvement in clinical outcomes, a reduction in hospitalization or death.

VIDEO:
SOT/FULL
Kathryn E. Flynn, Ph.D.
Duke Clinical Research Institute

AUDIO:
Runs: (:18)
Patients in the exercise group reported improvements in their quality of life greater than patients in the usual care group did. The difference between the 2 groups was modest but it was statistically significant and the improvements occurred early and they were sustained over time.

VIDEO:
B-ROLL
Patient exercising

AUDIO:
VO:
ALTHOUGH THE STUDY HAS ENDED, LISE? COLEMAN IS STILL EXERCISING AS IF IT HASN'T – AND IS A FIRM BELIEVER IN THE BENEFITS.

VIDEO:
SOT/FULL
Lise? Coleman
Has Heart Failure

AUDIO:
Runs: (:12)
When you exercise, you're helping your heart pump the blood through your body, you're helping your organs, you're helping yourself feel good, and when you feel good, you can do more, so exercise has been life changing for me.

VIDEO:
B-ROLL
Patient exercising

AUDIO:
VO:
HALEY WELDON, THE JAMA REPORT.

TAG:
Researchers say that, among other things, a drop in adherence to the home-based exercise program over time may have impacted the studies' results.

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