HealthyNCT00095485
Impact of Move to Clinical Research Center on Physical Activity of Employees
An observational study of Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will examine the changes that the move from NIH's Building 10 Clinical Center (CC) into the Clinical Research Center (CRC) may have on the amount of activity a person engages in daily, as registered by a pedometer, which measures horizontal and vertical steps. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any CC employee who is ambulatory, whose move date allows 10 days in CC prior to move, who wishes to participate in the study and whose work requirements include sufficient amount of walking so that they are not primarily confined to one office module.
Who cannot join
- inability to wear a pedometer; and record pedometer data
- musculoskeletal impairments that significantly limit ambulation, e.g. recent fractures, tendinitis
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Impact of Move to CRC on Physical Activity of Employees
This study will examine the changes that the move from NIH's Building 10 Clinical Center (CC) into the Clinical Research Center (CRC) may have on the amount of activity a person engages in daily, as registered by a pedometer, which measures horizontal and vertical steps. The investigators in this study hope to better understand the impact that the move will have had on one group of employees compared with the impact for other groups. Moving to a new work location may require physical activity that is different from what employees currently experience on the job. In the new location, they may be walking longer or shorter distances; they may also be climbing fewer or more stairs. In addition, they may need to walk more quickly to accomplish the same tasks. It is important to understand how the move from the CC to the CRC influences employees' health, well-being, and overall function. Physical measures, such as blood pressure, will be examined. So will how well employees are adjusting to the new location-for example, through information about work-related injuries.
Clinical Center employees who are able to walk, whose move dates allow 10 days in the Clinical Center before the move, who wish to participate in the study and are able to wear a pedometer, and whose work requirements include a sufficient amount of walking may be eligible for the study.
Read more
Participants will undergo the following procedures before the move into the CRC and then 1 month after the move. Each evaluation will take about 30 minutes:
- Brief history about age, medical problems, and current medications.
- Measurements of heart rate, blood pressure, height, and weight.
- Completing a brief questionnaire about the history of injuries, such as back pain, tendonitis, and bursitis.
In addition, participants will complete a questionnaire about daily life and leisure activities, consisting of 94 questions, to take about 20 minutes to complete. There will also be a measurement of the distance that participants can walk in 2 minutes.
A pedometer will be provided to each participant and will remain the property of that person. Participants will receive a daily log on which to record the number of steps they have walked and the distance as registered by the pedometer. About 5 minutes a day will be needed to record such information. The information that participants provide will be coded. They will not be personally identified, nor will the information be discussed with other people, including supervisors or co-workers.
Information collected will be analyzed for changes in activity patterns and will be analyzed by groups of staff. For example, the investigators may wish to compare the activity of nurses before and after the move and then compare that information with information collected from food service workers, or personnel serving as messengers or escorts. Participants may find the information gathered to be useful to them as individuals. That is, they may learn that their activity has increased as a result of the move to the new location. They may have benefited by having lost weight or lowered their blood pressure.
Read the detailed description
This project attempts to answer three questions about employees in the Magnuson Clinical Center. It is designed to study the effects of the move into the CRC on the amount of activity an individual performs daily in terms of units measured by a waist mounted pedometer (horizontal and vertical steps).
The hypotheses are:
- There will be an increase in amount of activity in CRC compared with CC (horizontal distance traveled, up/down activity including stairs and chairs).
- There will be an increase in walk velocity after move into CRC. This implies an increased level of aerobic capacity.
There will be an increase in the musculoskeletal symptoms, especially in the lower extremities and low back after move to the CRC. This implies there will be overuse of lower extremities because of increased activity.
- Conditions
- Healthy
- Keywords
- Activity Level, Musculoskeletal, Healthy Volunteer, Physical Activity
- Medical subject headings
- Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2004 (estimated)
- Study startNov 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095485
- Sponsor's protocol ID
- 050027
- Other IDs
- 05-CC-0027
- Status last verified
- Nov 2005
- First submitted
- 5 Nov 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Move to CRC on Physical Activity of Employees
- ClinicalTrials.gov ID
- NCT00095485
- Acronym / sponsor ID
- 050027
- Conditions
- Healthy
- Keywords
- Activity Level, Musculoskeletal, Healthy Volunteer, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Nov 2004
- Study completion
- Nov 2005
- First posted
- 8 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the changes that the move from NIH's Building 10 Clinical Center (CC) into the Clinical Research Center (CRC) may have on the amount of activity a person engages in daily, as registered by a pedometer, which measures horizontal and vertical steps. The investigators in this study hope to better understand the impact that the move will have had on one group of employees compared with the impact for other groups. Moving to a new work location may require physical activity that is different from what employees currently experience on the job. In the new location, they may be walking longer or shorter distances; they may also be climbing fewer or more stairs. In addition, they may need to walk more quickly to accomplish the same tasks. It is important to understand how the move from the CC to the CRC influences employees' health, well-being, and overall function. Physical measures, such as blood pressure, will be examined. So will how well employees are adjusting to the new location-for example, through information about work-related injuries.
Clinical Center employees who are able to walk, whose move dates allow 10 days in the Clinical Center before the move, who wish to participate in the study and are able to wear a pedometer, and whose work requirements include a sufficient amount of walking may be eligible for the study.
Participants will undergo the following procedures before the move into the CRC and then 1 month after the move. Each evaluation will take about 30 minutes:
- Brief history about age, medical problems, and current medications.
- Measurements of heart rate, blood pressure, height, and weight.
- Completing a brief questionnaire about the history of injuries, such as back pain, tendonitis, and bursitis.
In addition, participants will complete a questionnaire about daily life and leisure activities, consisting of 94 questions, to take about 20 minutes to complete. There will also be a measurement of the distance that participants can walk in 2 minutes.
A pedometer will be provided to each participant and will remain the property of that person. Participants will receive a daily log on which to record the number of steps they have walked and the distance as registered by the pedometer. About 5 minutes a day will be needed to record such information. The information that participants provide will be coded. They will not be personally identified, nor will the information be discussed with other people, including supervisors or co-workers.
Information collected will be analyzed for changes in activity patterns and will be analyzed by groups of staff. For example, the investigators may wish to compare the activity of nurses before and after the move and then compare that information with information collected from food service workers, or personnel serving as messengers or escorts. Participants may find the information gathered to be useful to them as individuals. That is, they may learn that their activity has increased as a result of the move to the new location. They may have benefited by having lost weight or lowered their blood pressure.
Detailed description
This project attempts to answer three questions about employees in the Magnuson Clinical Center. It is designed to study the effects of the move into the CRC on the amount of activity an individual performs daily in terms of units measured by a waist mounted pedometer (horizontal and vertical steps).
The hypotheses are:
- There will be an increase in amount of activity in CRC compared with CC (horizontal distance traveled, up/down activity including stairs and chairs).
- There will be an increase in walk velocity after move into CRC. This implies an increased level of aerobic capacity.
There will be an increase in the musculoskeletal symptoms, especially in the lower extremities and low back after move to the CRC. This implies there will be overuse of lower extremities because of increased activity.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any CC employee who is ambulatory, whose move date allows 10 days in CC prior to move, who wishes to participate in the study and whose work requirements include sufficient amount of walking so that they are not primarily confined to one office module.
Key exclusion criteria (2 listed)
- inability to wear a pedometer; and record pedometer data
- musculoskeletal impairments that significantly limit ambulation, e.g. recent fractures, tendinitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.