Full Text PA-97-060
 
EXPLORATORY GRANTS FOR MULTIDISCIPLINARY CLINICAL STUDIES OF SARCOPENIA
 
NIH GUIDE, Volume 26, Number 17, May 23, 1997
 
PA NUMBER:  PA-97-060
 
P.T. 34

Keywords: 
  Muscle Disorders 
  Aging/Gerontology 
  Biomedical Research, Multidiscipl 
  074030 
  Epidemiology 

 
National Institute on Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
THIS PROGRAM ANNOUNCEMENT IS A REVISION OF THE PA APPEARING IN THE
MAY 9 ISSUE OF THE NIH GUIDE.  THIS REVISION ADDS THE NIAMS AS A
SPONSORING INSTITUTE OF THIS PROGRAM ANNOUNCEMENT.
 
PURPOSE
 
The National Institute on Aging (NIA) invites exploratory research
grant (R21) applications for multidisciplinary, clinical studies on
the mechanisms underlying the physical functional consequences of
sarcopenia in older persons. This NIA exploratory grants program is
intended to facilitate new collaborative efforts in the development
of novel scientific hypotheses on the causes of changes in skeletal
muscle morphology and/or metabolism which lead to physical
disabilities in old age, by providing research support for the
appropriate pilot/feasibility studies to refine these hypotheses.
Multidisciplinary approaches may include collaborations between
various types of clinical research expertise (e.g., epidemiology,
geriatrics, rehabilitation medicine, biomechanics, exercise
physiology), or between basic and clinical researchers, with or
without previous aging research experience.
 
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 (PA), Exploratory Grants for Multidisciplinary
Clinical Studies of Sarcopenia, is related to the priority areas of
chronic diseases and disabling conditions. Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report: Stock No.
017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through
the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications for exploratory (R21) research grants may be submitted
by foreign and domestic non-profit and for-profit, public and
private, institutions such as a university, college, hospital,
laboratory, units of State and local government; and eligible
agencies of the Federal government. Applications may include
collaborative arrangements between scientists from a single
institution or multiple institutions. Simultaneous submissions of the
same research project as both an exploratory grant and a regular
research grant (RO1) will not be allowed.
 
Racial/ethnic minority individuals, women and persons with
disabilities are encouraged to apply as Principal Investigators.
 
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 should be included
with the application.
 
MECHANISM OF  SUPPORT
 
This program will use the NIH exploratory grant (R21) mechanism.
Applicants may request up to $100,000 per year in direct costs,
exclusive of indirect costs for any collaborating institutions. Funds
may be included to support travel for the collaborators and/or the
purchase of equipment, as justified by the needs of the proposed
research. Because the nature and the scope of the research proposed
in response to this PA may vary, it is anticipated that the size of
awards will vary as well. The total project period for an application
submitted in response to this PA may not exceed two years. These
grants are non-renewable and continuation of projects developed under
this program will be through the traditional unsolicited grants
program.
 
RESEARCH OBJECTIVES
 
Background
 
The physical functional consequences of sarcopenia in the elderly
include mobility problems, falls and an increased risk for physical
functional dependence. Numerous studies have attributed the inability
of older persons to perform various tasks to a decline in muscle
function (e.g., loss of strength, decreased muscle power), but there
is a paucity of clinical information about the mechanisms leading to
muscle dysfunction in old age. In the meantime, various animal models
and in vitro systems developed to study specific alterations in
muscle quality suggest that factors such as age-associated changes in
muscle contractility, satellite cell function,
innervation/denervation and myofibrillar protein turnover could play
a role in muscle dysfunction. From a clinical perspective, it has
been difficult to interpret the animal and in vitro data since very
few clinical studies have attempted to bridge the gap between these
mechanistic data and the clinical assessment of the physical
functional status of the elderly. Given the wide variety of
age-related changes in muscle quality which are thought to contribute
to physical functional problems in old age, multidisciplinary
approaches will be needed to better define the relationship between
sarcopenia and deficits in physical performance.
 
To initiate discussions on promising multidisciplinary approaches and
novel methodologies available for elucidating the alterations in
muscle quality underlying deficits in physical performance in the
elderly, the NIA convened the workshop, "Sarcopenia and Physical
Performance in Old Age" on  July 9-10, 1996. Diverse research
backgrounds (e.g., aging and non-aging research expertise, clinical
and basic science investigators, skeletal muscle biology, exercise
physiology, neurology, statistics) were represented by the workshop
participants in the scientific sessions, which included: 1) Specific
Study Design Considerations, 2)  Muscle Function and Physical
Performance and 3) Muscle Function and Pathophysiology. Abstracts of
the presentations and a summary of the workshop recommendations will
be published as a supplement to Muscle & Nerve, in  early 1997. The
main goals of the workshop were to: 1) stimulate more clinical
studies of the relationship between changes in muscle function and
specific limitations in physical performance, 2) encourage a focus on
disabled and frail elderly populations, as well as minorities, 3)
promote more comprehensive evaluations of muscle quality in clinical
studies, particularly through the use of non-invasive measures of
muscle properties, and 4) explore the possibility of more detailed
analysis of human muscle biopsy samples through the adaptation of in
vitro methods commonly used in animal studies. The NIA exploratory
grants program is intended to encourage collaborations between
various scientific disciplines to operationalize the workshop goals
into future clinical studies of sarcopenia and its physical
functional consequences. It is anticipated that the pilot/feasibility
studies supported by the NIA exploratory grants program will
constitute the scientific framework for larger, innovative clinical
studies of the mechanisms underlying disabilities related to
sarcopenia in old age.
 
Objectives
 
This initiative will provide research support to explore novel
multidisciplinary approaches for understanding the clinical relevance
of changes in skeletal muscle (i.e., at the cellular or organ level)
in the context of the physical functional status of an older
individual and, vice versa.
 
Applications submitted in response to this PA must address the
mechanistic aspects (i.e., alterations in skeletal muscle
mass/quality with aging) of physical disabilities associated with
sarcopenia. Topics of interest include, but are not limited to:
 
o  Quantitative assessment of muscle quality and function associated
with various levels of physical performance (e.g., relationship
between muscle fatigue and ability/inability to climb stairs; rate of
muscle force development and ability to react to "time-critical"
situations)
 
o  Pilot studies of the clinical application of basic research
findings
 
o  Correlative data between non-invasive measures of muscle quality
and measures from animal or in vitro experimental measures of muscle
properties (e.g., blood supply, contractility)
 
o  Feasibility studies required to "translate" findings from
small-scale mechanistic studies to population-based studies of the
functional consequences of sarcopenia
 
o  Potential ethnic or gender differences in the determinants (i.e.,
of changes in muscle quality/function) of physical disabilities
associated with sarcopenia
 
o  Impact of chronic diseases on muscle function/quality and its
physical functional consequences in old age
 
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 policy results from the
NIH Revitalization Act  of 1993 (Section 492B of Public Law 103-43)
and supersedes and strengthens the previous 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. 5/95) and will be accepted at the February 1, June 1 and
October 1 application deadlines as indicated in the application kit.
Applications kits are available at most institutional offices of
sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone 301-710-0267, Email: [email protected]. The title
and number of the program announcement must be typed in section 2 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
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817  (for express/courier service)
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established Public
Health Service referral guidelines.  Applications that are complete
will be evaluated for scientific and technical merit by study
sections of the Division of Research Grants, NIH, in accordance with
the standard NIH peer review procedures. As part of the initial merit
review, all applications deemed to have the highest scientific merit,
generally the top half of the applications under review will be
discussed, assigned a priority score and receive a second level of
review by the appropriate national advisory council.
 
Review Criteria
 
o  Scientific, technical, or medical significance and originality of
the 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, collaborators and key research personnel, particularly
but not exclusively, in the area of proposed research;
 
o  Availability of adequate facilities, general environment for the
conduct of the proposed research and feasibility of the collaborative
arrangements;
 
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.
 
AWARDS CRITERIA
 
Scored applications will compete for available funds with all other
scored applications assigned to that Institute/Center. 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 program announcement.
 
INQUIRIES
 
Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applications is
welcome.
 
Direct inquiries regarding programmatic issues to:
 
Chhanda Dutta, PhD
Geriatrics Program
National Institute on Aging
Gateway Building, Suite 3E-327
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Telephone:  (301) 435-3048
FAX:  (301) 402-1784
Email:  [email protected]
 
Richard W. Lymn, PhD
Muscle Biology and Musculoskeletal Fitness Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS 49E
Bethesda, MD  20892-6500
Telephone:  (301) 594-5128
FAX:  (301) 480-4543
Email:  [email protected]
 
Direct inquiries regarding fiscal matters to:
 
Mr. Joseph Ellis
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  [email protected]
 
Ms. Sally A. Nichols
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS 49F
Bethesda, MD  20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
Email:  [email protected]
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.866, Aging Research and No. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research.  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 PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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