Full Text PA-95-004 PHYSICAL ACTIVITY AND CARDIOPULMONARY HEALTH NIH GUIDE, Volume 23, Number 38, October 28, 1994 PA NUMBER: PA-95-004 P.T. 34 Keywords: Exercise Cardiovascular Diseases Pulmonary Diseases Disease Prevention+ Health Promotion National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Nursing Research PURPOSE To stimulate well-defined studies in the area of physical activity related to cardiopulmonary health. Four major areas of research are encouraged: (1) Physical Activity Dose-Effect Relationships and Determinants in Children and Adolescents; (2) Physical Activity Dose for Prevention of Coronary Heart Disease in Adults; (3) Physical Activity and Respiratory Health for Children, Adolescents, and Adults with Asthma; (4) Physical Activity and Health for Children, Adolescents, and Adults with Cystic Fibrosis. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. This Program Announcement, Physical Activity and Cardiopulmonary Health, is related to the priority area of physical activity. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for education research grants (R18) and domestic applications may not include international components. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be by research project grants (R01) and research demonstration and dissemination projects (R18). The adolescent and adult studies in the coronary heart disease (CHD) area can be observational (e.g., longitudinal cohort studies) or intervention studies (e.g., randomized controlled trials). Focused studies are encouraged. For all age groups in the asthma and cystic fibrosis areas, only small focused intervention studies are encouraged. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute for Nursing Research (NINR) will accept only R01 applications. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. For more information about the 75 GCRCs across the nation, call (301) 594-7945. RESEARCH OBJECTIVES Health benefits of physical activity have been identified, and these depend largely on long-term adherence to an active lifestyle over the major transitional periods in an individual's lifespan. Physical activity and fitness are important components of the 22 priority areas in the goals and objectives of the Healthy People 2000 effort that provide the cornerstone of the Nation's public health agenda for the 1990s. Children/Adolescents and Cardiovascular Health Many of the risk factors for coronary artery disease, hypertension, obesity, noninsulin-dependent diabetes, and osteoporosis begin in childhood and youth. Study findings indicate that as many as 60 percent of U.S. children exhibit at least one modifiable adult risk factor for coronary heart disease by the age of 12. Evidence also suggests that physical activity in childhood is a determinant of physical activity in adulthood. Results from the 1990 national school-based Youth Risk Behavior Survey (YRBS) that involves youth ages 12 to 22 show that 37 percent of 9th through 12th grade students in the U.S. engaged in vigorous physical activity three or more days per week for 20 minutes or more per session. The prevalence of vigorous physical activity declines with increasing grade levels from 40.1 percent in 9th grade to 31.8 percent in 12th grade and differs by gender with half of male students, but only a quarter of female students, being vigorously active. The natural course of habitual activity during the pediatric years has been described in a number of small-scale studies. Objectively measured physical activity declines dramatically with age with approximately a 50 percent decrease between ages 6 and 16 and declines throughout adulthood. Though gender differences in infancy are minimal, studies of preadolescents and adolescents show males to be more physically active than females. Little is known about the distribution of patterns (type, frequency, duration, intensity) of physical activity of boys and girls of different ethnic and socioeconomic background during adolescence. Adults and CHD Prevention Studies of physical activity and health provide substantial evidence that increasing physical activity should be recommended to all sedentary adults. The research base, however, does not provide clear direction as to the content of the recommendations that should be made to people with different characteristics and different goals. More research is needed on the efficacy of various "doses" of physical activity (i.e., combination of mode, intensity, duration of sessions, frequency, and duration of program) in decreasing physiological coronary heart disease (CHD) risk factors (e.g., blood pressure, lipoproteins, obesity) and for increasing cardiorespiratory fitness. In addition, research is needed to identify optimal activity recommendations for achieving a group effect, which is a function of both the efficacy in changing physiological factors and of adherence. Further research on the effects of varying physical activity "doses" for adults can provide the scientific basis for public health and clinical recommendations that could be more specific than currently can be made. Accumulating evidence indicates that low cardiorespiratory fitness increases risk of CHD, independent of other known risk factors. Physical activity is associated with cardiorespiratory fitness and with other CHD risk factors, and exercise can improve lipoprotein profile, can lower blood pressure, and is an important component of weight control. Still unknown, however, are the minimal and optimal exercise doses (i.e., combination of mode, intensity, duration of sessions, frequency, and duration of program) to improve CHD risk factors and to improve cardiorespiratory fitness. There is some evidence that physical activity of a moderate, rather than vigorous, intensity may be more efficacious in decreasing elevated BP and improving serum lipoprotein profile. The question remains unanswered as to whether there are different minimal and optimal doses of activity for improving risk factors than for enhancing cardiorespiratory fitness. Research has identified effective regimens for improving cardiorespiratory fitness, yet the minimal threshold of activity to improve and maintain fitness, particularly long-term, is still unknown. In addition, the efficacy of differing doses of physical activity on the CHD risk factors and on cardiorespiratory fitness has not been adequately studied in different population groups (e.g., by age, gender, menopausal status, race/ethnicity) that may have different responses to exercise. Mechanisms by which physical activity may affect the various CHD risk factors also deserve additional study, as do possible adverse effects of various intensities of physical activity. Asthma Asthma is a serious chronic condition, affecting 12 million Americans, 4 million of whom are under the age of 18. Between 1979 and 1989, the prevalence of asthma in the United States increased 61 percent. Children under 15 years old experienced the greatest increase in hospitalizations among all age groups, with an increase of 45 percent between 1979 and 1987. The burden of asthma falls disproportionately on the minority population in the United States. For example, the prevalence of asthma is higher in blacks than in whites, and blacks are almost three times as likely to die from asthma as are whites. Asthma is the leading reason for school absence due to chronic disease, and it is also a major reason for adults missing work. About one third of children with asthma restrict their physical activities, including participation in physical education and sports despite the fact that with modern treatment generally no restriction is necessary, and indeed a number of athletes with asthma have won Olympic medals. It is not known how much adults restrict their physical activities because of asthma. Aerobic fitness can be increased in asthmatic children, adolescents, and adults and improved fitness may correlate with a decrease in exercise-induced bronchospasm in asthmatic children. This is similar to the results of increasing fitness in adult asthmatics. There is a need for additional research studying the effects of physical activity on respiratory health and fitness and to determine if the kind of exercise, the length, and other factors are related to optimal physical fitness for asthma patients of various severity states. In addition, research should be conducted to determine what types of interventions will result in patients with asthma maintaining an optimal physical activity program for different age groups. Further research in this area can provide the scientific basis for public health and clinical recommendations that could be more specific than currently can be made. Cystic Fibrosis Cystic fibrosis is the most common inherited life-shortening disease among Caucasians, affecting approximately 30,000 people in the U.S. The treatment regimen is complex and arduous. With modern therapy, the median life expectancy has increased to about 30 years of age. However, although the reasons are not understood, survival has been about three years longer for males than females. Patients with cystic fibrosis suffer progressive loss of pulmonary function and decline in exercise tolerance. A highly significant correlation between exercise tolerance and 8- year survival has been shown. Some studies have shown that supervised exercise programs benefit patients in terms of improved exercise tolerance or improved pulmonary function. Some other studies have not shown any benefits in terms of improved exercise tolerance function. While the results from some programs are promising, studies have suffered from design flaws or various other limitations. None has employed a randomized controlled design and sample sizes have been small. Adherence generally has been poor. Despite the limitations and disagreements among published studies on the effects of exercise programs for patients with cystic fibrosis, almost all cystic fibrosis centers recommend exercise for at least some of their patients. Additional research is needed to ascertain the effects of physical activity on the health of cystic fibrosis patients and to determine the kind of exercise, length, and other factors that are optimal for cystic fibrosis patients of various age levels and severity status. In addition, research should be conducted to determine what types of interventions will result in patients with cystic fibrosis maintaining an optimal physical activity program. Further research in this area can provide the scientific basis for public health and clinical recommendations that could be more specific than can be currently made. Relevant Research The following are examples of research and specific study questions relevant to this program announcement: o Studies to determine the effects of varying physical activity regimens on physical fitness and on CHD risk factors for coronary artery disease (e.g. obesity, lipoproteins, blood pressure) in adolescents are needed. This includes investigations on the dose associated with, or required, to effect change in fitness and in adult coronary risk factors identified in adolescents. What are the minimum physical activities that can be pursued to promote a sufficient level of cardiovascular fitness to maintain health, and are these age related? How are intensity and duration of activity related to cardiovascular fitness over time? For example, lower intensity activity may promote cardiovascular fitness but take a longer time to obtain an effect than higher intensity activity. Because obesity is associated with a variety of increased risk factors and weight loss is associated with their decline, research should focus on the relative roles of physical activity and calorie reduction in weight loss and, in turn, lowered risk factors. The relationship of physical activity to lipids appears to vary depending on whether the sample is pre- or postpuberty. What is the role of hormonal variables associated with the onset of puberty in the relationships among physical activity, fitness, and lipids? o Studies of the determinants and efficacy of interventions to prevent the decline in physical activity during adolescence are needed. Attention to this transition period is critical since it is recognized that physical activity and fitness decline, particularly in females during the early teen years. What are effective approaches to prevent this decline in females? o There is little information in the field on the determinants of various patterns of physical activity including sedentary behavior, and low-, moderate-, and vigorous-intensity activities in adolescents. Different types or patterns of activity may have different health effects, different determinants, or different probabilities of maintenance over time. What are the determinants of the types of activity and patterns of participation in terms of type, frequency, duration, and intensity of activity? For example, regular walking may provide important benefits and be maintained, but the determinants of this type of activity may be distinct from those of team sports in youth. o In healthy but sedentary adults, what minimal "dose" of physical activity is required to improve cardiorespiratory fitness (i.e., intensity, duration of bouts, frequency of sessions, duration of program)? Is there a threshold effect and, if so, what is the minimum dose required to achieve an effect? Are shorter more frequent bouts of activity as efficacious as longer, sustained bouts? Once fitness has improved, what minimal dose is required for maintenance of fitness? What physical activity dose(s) can prevent age-related declines in fitness (e.g., in the elderly)? o In individuals with physiological CHD risk factors (e.g., elevated blood pressure, low HDL cholesterol, obesity) but without clinical CHD, what physical activity regimen is required to improve the risk factors? Does the regimen differ for different risk factors? Is there a threshold effect, and if so, what is the minimum intensity, duration of sessions, frequency, and duration of program required to achieve an effect? Are modes of activity other than aerobic training efficacious? What overall program of activity can achieve optimal efficacy for various risk factors or for all the risk factors? By what biological mechanisms does physical activity affect physiological CHD risk factors? o For both cardiorespiratory fitness and CHD risk factor effects, what physical activity prescriptions are more effective in achieving a group effect (which is related to both the level of compliance and to the physiologic effects)? Are the various risk factors and fitness affected differentially by different activity recommendations? For example, is moderate activity with higher compliance as or more effective in achieving group changes than vigorous activity with lower adherence? Are shorter, more frequent bouts of activity as or more effective than longer, sustained bouts? What is the relative effectiveness of recommending incorporation of physical activity in daily lifestyle routines as compared with traditional exercise training sessions? What are the determinants of various physical activity patterns in adults? o How are patients with asthma or cystic fibrosis affected by various physical activities, organized sports, and free-play? If advantageous, what is the optimal program of physical activity. o What is the minimal dose of physical activity (i.e., intensity, duration of bouts, frequency of sessions, duration of program) for a specific age group to improve respiratory health? Is there a threshold effect? If so, what is the minimum dose required to achieve an effect? Are shorter more frequent bouts of activity as efficacious as longer, sustained bouts? What minimal dose is required for maintenance of fitness? o What physical activity prescription is most effective in achieving a group effect that is related to both the level of adherence and the physiologic consequences of activity for individuals with asthma or cystic fibrosis? Is moderate activity with higher adherence as or more effective in achieving group changes than vigorous activity with lower adherence, and is either of these as or more effective than longer, less intense bouts? o What is the relative effectiveness of incorporation of physical activity in daily lifestyle routines as compared with traditional exercise training sessions for individuals with asthma or cystic fibrosis? o What interventions result in asthma or cystic fibrosis patients' maintaining optimum physical activity? o For all of the above questions are there different effects for various demographic groups (age, sex, race/ethnicity, socioeconomic status)? INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The title and number of this program announcement must be typed in line 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Although this is a program announcement sponsored by three Institutes, other Institutes/Centers of the NIH also may have an interest. Applications will be assigned to the most appropriate Institute/Center on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; and o program balance among research areas of the announcement. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elaine Stone, Ph.D., M.P.H. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 604 Bethesda, MD 20892-9125 Telephone: (301) 496-3503 FAX: (301) 480-1357 email: elaine_stone@nih.gov Denise Simons-Morton, M.D., Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 604 Bethesda, MD 20892-9125 Telephone: (301) 496-3503 FAX: (301) 480-1357 email: denise_simons-morton@nih.gov P. Scott Allender, M.D., M.S. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 604 Bethesda, MD 20892-9125 Telephone: (301) 496-2465 FAX: (301) 480-1357 email: phillip_allender@nih.gov Joan Wolle, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 FAX: (301) 594-7487 email: joan_wolle%nihhwb1.bitnet@cu.nih.gov Judith Fradkin, M.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 Bethesda, MD 20892 Telephone: (301) 594-7567 FAX: (301) 594-9011 email: judithf@dvsgate.niddk.nih.gov Van Hubbard, M.D., Ph.D. Nutritional Sciences Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A18B 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7573 FAX: (301) 594-7504 email: vanh@dvsgate.niddk.nih.gov June Lunney, Ph.D., R.N. Health Promotion/Disease Prevention Branch National Institute of Nursing Research Building 45, Room 3N12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-7397 FAX: (301) 480-8260 e:mail: jlunney@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Mrs. Marie A. Willett Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A12 Bethesda, MD 20892 Telephone: (301) 594-7434 FAX: (301) 594-7492 email: MUM@CU.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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