SOURCES SOUGHT
A -- Clinical Trial for Response and Adaptation to Aerobic Exercise in Patients with Pulmonary Hypertension
- Notice Date
- 5/19/2008
- Notice Type
- Sources Sought
- NAICS
- 622310
— Specialty (except Psychiatric and Substance Abuse) Hospitals
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- SSN05192008
- Response Due
- 7/3/2008
- Point of Contact
- Ann G Argaman,, Phone: (301) 594-5919, Ann G Argaman,, Phone: (301) 594-5919
- E-Mail Address
-
ann.argaman@nih.gov, ann.argaman@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health, Clinical Center is conducting a market survey/sources sought to help determine the availability and technical capability of qualified small businesses, veteran-owned small businesses, service disabled veteran-owned small businesses and/or HUBZONE small business capable of serving the needs mentioned below. This market survey/sources sought announcement is not a request for proposals and the Government is not committed to award a contract pursuant to this announcement. The information from this market research is for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not pay for any costs incurred in the preparation of information for responding to this market survey. A randomized trial (Phase 2) to determine the safety and effectiveness of aerobic exercise for patients who have pulmonary hypertension (PH) shall be conducted. An essential treatment for almost all cardiovascular and pulmonary disorders is aerobic exercise training. However, fundamental information about the mechanisms underlying exercise training and its benefits is lacking for patients who have PH. This research study will begin to address this information gap. Subjects to be enrolled in the trial will be adults (over the age of 21 years) with a confirmed medical diagnosis of PH who will be recruited from sites throughout the Baltimore/Washington area. Informed consent will be obtained from those deemed appropriate for participation in the study. An orientation to the study will be provided to research participants by the contractor. In addition, a subset of the baseline tests will be performed at this time including: accelerometry based activity, 6-minute walk distance, and a number of quality of life and functional measures. Subsequently, each participant will be scheduled for a visit to NIH-RMD. During this visit, they will undergo review of their medical records and a full examination by an NIH physician to confirm their suitability for the study. Once suitability for enrollment is confirmed, participants will complete the remaining baseline research tests which will be performed at NIH-Rehabilitation Medicine Department in Bethesda, Maryland. Participants will be randomized by scientists at NIH-RMD to one of two treatment groups: 1) aerobic exercise training plus education or 2) education only. Subjects in the “aerobic exercise training plus education” group will complete exercise training and educational sessions concurrently. Subjects enrolled in the “education only” group will complete educational sessions first, followed by aerobic exercise training. Study participants will receive all of their aerobic exercise training and educational sessions at the contractor’s facility which should be located within a reasonable distance to NIH in Bethesda, Maryland so that participants who are generally medically fragile do not have to travel excessive distances from their homes to participate in the trial. Aerobic exercise training will consist of a 10-week regimen of supervised treadmill or over ground walking three times a week. Exercise session duration will be 30 minutes and will progress to 45 minutes per session over the 10 weeks. The intensity of exercise will be between 70 and 80% of the heart rate reserve. Educational sessions will be held twice a week for 10 weeks. Subjects in both arms of the study will participate concurrently however, study sessions for the two groups will be conducted in distinct areas and at separate times. The majority of study outcome measures will be assessed at NIH-RMD. These will include pre- and post-intervention comparisons of treadmill exercise tests to assess heart rate, pulse oximetry, EKG, maximum oxygen consumption, oxygen on-kinetics, bioelectrical impedance cardiography, and near infrared spectroscopy measurements of muscle oxygenation. In addition, collaborators at the contractor’s facility will assess accelerometry based activity, 6-minute walk distance, and a number of other quality of life and functional measures including: International Physical Activity Questionnaire, Fatigue Severity Scale, SF-36, the Human Activity Profile, Stages of Exercise Adoption Scale, Self-Efficacy, Social Support Questionnaire, and Patient Health Questionnaire. For subjects in the exercise plus education group, these tests will be conducted before the start of aerobic training and again at the end of 10-weeks of training. For subjects in the education only group, these tests will be conducted before the start of educational sessions, at the end of 10-weeks of educational sessions, and again at the end of 10-weeks of aerobic training. Scope / Objective: This research study initiates a line of research with an overarching goal of formulating exercise rehabilitation guidelines for patients who have PH. If the effect of exercise therapy is to be fully understood, the factor limiting aerobic metabolism must be identified and its mechanism characterized. This information may have a bearing on the eventual provision of exercise prescriptions guidelines and will help to determine whether a positive exercise training effect occurs by an intervention on the mechanism of limitation or a compensatory effect that offsets the limitation. This study represents a unique opportunity to assess the effects of exercise on patients with PH and may open up valuable new treatment options for these patients. In adults who have PH, the specific objectives of the research are to: 1.examine responses and adaptations to exercise at quantifiable target intensities that correspond to energy expenditure requirements 2.understand changes in symptom limited and sub-maximal exercise test results, using task-specific and task-similar testing and training modalities 3.examine the effects of task-specific exercise training on physical activity 4.determine the relationships between patient’s ability to achieve and maintain an aerobic steady state and to sustain physical activity 5.determine the effect of aerobic exercise training on psychosocial and behavioral functioning and other HRQOL components 6.based on the progression in training volume, delineate the time course of improvement in work capacity across an aerobic exercise training program 7.explore the relationships among measures of aerobic metabolic function and potential mechanistic factors that may limit oxidative metabolism 8.examine the relationships among indices of aerobic metabolic function and the mechanisms by which of aerobic exercise training improves oxidative metabolism Performance requirements and desired outcomes for base period of performance The contractor will be responsible for meeting the specified performance requirements and outcomes during the contract period covering August 11, 2008 through August 10, 2010. 1)Requirement: Identify and recruit potential study participants. Obtain initial consent using both the contractor’s and NIH forms if the participant has not already consented to participate. Outcome: Potential study participants will qualify for further medical evaluation at NIH-RMD to determine eligibility for the study based on established criteria as specified in the study protocol. All study procedures will be thoroughly explained to potential participants in lay language addressing any questions that participants raise. All necessary signatures will be obtained and copies of the consent forms will be maintained as specified by NIH-RMD investigators. 2)Requirement: Provide educational sessions as specified in the protocol for subjects enrolled in the PH study. Outcome: Experimental and control group populations will be kept separate from one another for the duration of the study. The following educational classes will be provided over ten weeks (two times a week): a)Anatomy & physiology / Disease processes b)Lung disease / Breathing retraining c)Inhaler use / Lung medications d)Lung medications (continued) e)Oxygen therapy / Sleep disorders f)Nutrition g)Panic control / Relaxation techniques h)Emotional and social well-being i)Preventing infection / Airway clearance j)Diagnostic testing k)Advanced directives l)Community resources / Quiz / Review m)Home recommendations (excluding exercise recommendations) 3)Requirement: Provide aerobic exercise as specified in the protocol for subjects enrolled in the PH study. Outcome: Experimental and control group populations will be kept separate from one another for the duration of the study. The following exercise regimen will be provided over ten weeks (three times a week): a)Exercise training will consist of a 10-week regimen of supervised treadmill or over ground walking. b)Exercise session duration will be 30 minutes and will progress to 45 minutes per session over the 10 weeks. c)The sessions will be continuous unless the patient cannot tolerate the regimen, in which case exercise bouts will be alternated with rest intervals until the total time of the exercise bouts equals the 30-45 minute total exercise time target. d)The intensity of the exercise will be between 70 and 80% of the heart rate reserve, defined as 0.70 and 0.80 (maximum heart rate – resting heart rate) + resting heart rate, as determined during the pre-exercise maximum treadmill test. e)The frequency of the sessions will be three times per week 4)Requirement: Pre and post-intervention tests will be performed as specified in the protocol for subjects enrolled in the PH study. Outcome: All tests will be administered according to the timelines and standards established in the study protocol and as specified by NIH investigators. A standardized six minute walk test will be performed. Accelerometers will be applied to study participants according to standardized procedures specified by NIH-RMD investigators. Additional tools to be administered include: a)International Physical Activity Questionnaire b)Fatigue Severity Scale c)SF-36 d)Human Activity Profile e)Stages of Exercise Adoption Scale f)Self-Efficacy Scale g)Social Support Questionnaire h)Patient Health Questionnaire i)St. George Respiratory Questionnaire j)International Quality of Life Questionnaire (IPAQ) k)Cambridge Pulmonary Hypertension Outcome Review (CmPhOR) 5)Requirement: Data on subject enrollment, participation in education sessions, and performance in aerobic exercise sessions will be collected and maintained for each study participant. Outcome: All data will be summarized (as specified below) and delivered in electronic form (in an access database) to the primary investigator at NIH on a quarterly basis. a)Summary table/s on subject enrollment. Data should be provided on each enrolled subject including their age, sex, primary diagnosis, secondary diagnoses, medications, educational level, and living situation. b)Summary table on educational sessions including the number and % of educational sessions attended. c)Summary table/s on exercise sessions including: The number and % of exercise sessions attended Amount of time walked at each session Whether session was comprised of treadmill or over ground Number of rest intervals that the participant required at each session (if any) Average heart rate during session Data from the pedometers. 6)Requirement: Maintain communication with NIH-RMD project investigators regarding study related issues. Outcome: Contractor research study staff will participate in weekly telephone conferences with NIH-RMD project investigators and provide information requested by NIH investigators via a weekly agenda. Option 1: Potential additional study activities during the base period of performance (August 11, 2008 through August 10, 2010) In order to optimize subject recruitment and participation in this clinical trial, the Government may determine that it is beneficial to extend hours of operation of the Pulmonary Rehabilitation Program to perform the scope of work under this contract. On a quarterly basis, the Government will assess the need for such an extension of hours to maximize potential for recruitment of additional study participants. Option 2: Potential additional study activities beyond the base period of performance (August 11, 2008 through August 10, 2010) It is anticipated that additional study participants may be required. Pulmonary hypertension is a rare condition and it may prove to be more difficult than anticipated to recruit participants that meet the study inclusion criteria and do not possess exclusion criteria. Also, the level of potential withdrawal from the study is not known with certainty, and additional subjects may need to be enrolled to accommodate this loss. This option will extend time of study to recruit additional participants with a maximum of 25. This would extend the period of performance by an additional twelve months. This request is for interested firms with the capability of providing the required services to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS Code 622310 with a size standard of $31.5 million dollars. All respondents are requested to identify their firm’s size and type of business. Interested firms responding to this source sought should adhere to the following: a. Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government’s requirements as described above. The capability statement should contain sufficient enough detail for the Government to make an informed decision regarding your capabilities. b. The capability statement should include past performance references, descriptions of key personnel capabilities and any other information deemed relevant which clearly demonstrates your ability to conduct the Phase 2 Clinical trial as described above..
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=4eab1f2b1423894adfc9668614338872&tab=core&_cview=1)
- Place of Performance
- Address: Bethesda, Maryland, 20892-0001, United States
- Zip Code: 20892-0001
- Zip Code: 20892-0001
- Record
- SN01576333-W 20080521/080519222956-4eab1f2b1423894adfc9668614338872 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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