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 301/435-0714.  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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