Muscular AtrophyCCDNCT00835601
Resistive/Cardiovascular Training Study
An observational study of Muscular Atrophy, run by University of California, San Francisco.
Trial summary
This is a training study in healthy volunteers to characterize gains in lower-body resistive strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD) we have developed for the National Space Biomedical Research Institute. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Atrophy
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to May 2011
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy men and women 25-55 years of age who are not exercisers
Who may be able to join
- Healthy men and women
- 25-55 years old
- Do not exercise on a regular basis
Who cannot join
- Have not been diagnosed with hypertension, diabetes, high cholesterol, cardiovascular disease or asthma and other pulmonary disorders
About this study
Official title: An Integrated Musculoskeletal Countermeasure Battery for Long-Duration Lunar Missions
This is a training study in healthy volunteers to characterize gains in lower-body resistive strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD) we have developed for the National Space Biomedical Research Institute. The CCD is a single platform which contains interchangeable modules for cardiovascular stepping exercises and lower body resistive exercises including squats, heel raises, abductor and adductor exercises and knee extension and flexion. The platform has the capability to tilt, yaw and pitch, and to translate in three dimensions in order to challenge the neurovestibular system. The underlying goal of the project is to provide a compact and efficient exercise modality that will prevent deterioration of the cardiovascular and musculoskeletal systems, and the neurovestibular system, in long-duration spaceflights. The goal of the current study is simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed for the device will improve strength and VO2 max. Subjects are tested for lower body resistive strength and V02max at baseline, then are trained for 12 weeks, and tested again at followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows sufficient power to detect 95% percent confidence intervals in the changes in the strength and V02max measures of roughly 10-20%. If we observe gains in these indices which are similar to those reported in the literature for simultaneous cardiovascular and resistive strength protocols, then we believe that there is sufficient evidence to test CCD in a bedrest model of long-duration spaceflight.
- Conditions
- Muscular Atrophy
- Medical subject headings
- Muscular Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Measured: 6-12 weeks
Leg Press Strength
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular AtrophyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835601
- Sponsor's protocol ID
- CCD Training Study
- Other IDs
- NSBRI BL-01301
- Acronym
- CCD
- Status last verified
- May 2011
- First submitted
- 29 Jan 2009
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Musculoskeletal Countermeasure Battery for Long-Duration Lunar Missions
- ClinicalTrials.gov ID
- NCT00835601
- Acronym / sponsor ID
- CCD / CCD Training Study
- Conditions
- Muscular Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Feb 2009 (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 is a training study in healthy volunteers to characterize gains in lower-body resistive strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD) we have developed for the National Space Biomedical Research Institute. The CCD is a single platform which contains interchangeable modules for cardiovascular stepping exercises and lower body resistive exercises including squats, heel raises, abductor and adductor exercises and knee extension and flexion. The platform has the capability to tilt, yaw and pitch, and to translate in three dimensions in order to challenge the neurovestibular system. The underlying goal of the project is to provide a compact and efficient exercise modality that will prevent deterioration of the cardiovascular and musculoskeletal systems, and the neurovestibular system, in long-duration spaceflights. The goal of the current study is simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed for the device will improve strength and VO2 max. Subjects are tested for lower body resistive strength and V02max at baseline, then are trained for 12 weeks, and tested again at followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows sufficient power to detect 95% percent confidence intervals in the changes in the strength and V02max measures of roughly 10-20%. If we observe gains in these indices which are similar to those reported in the literature for simultaneous cardiovascular and resistive strength protocols, then we believe that there is sufficient evidence to test CCD in a bedrest model of long-duration spaceflight.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy men and women 25-55 years of age who are not exercisers
Key inclusion criteria (3 listed)
- Healthy men and women
- 25-55 years old
- Do not exercise on a regular basis
Key exclusion criteria (1 listed)
- Have not been diagnosed with hypertension, diabetes, high cholesterol, cardiovascular disease or asthma and other pulmonary disorders
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
VO2max
Time frame: 6-12 weeks
Leg Press Strength
Time frame: 6-12 weeks
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 16 May 2011.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscular Atrophy, run by University of California, San Francisco.
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 3 inclusion and 1 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 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
VO2max (time frame: 6-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 16 May 2011.