Resistive/Cardiovascular Training Study (CCD)
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Purpose
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.
| Condition |
|---|
|
Muscular Atrophy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | An Integrated Musculoskeletal Countermeasure Battery for Long-Duration Lunar Missions |
- VO2max [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]
- Leg Press Strength [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | January 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Healthy men and women 25-55 years of age who are not exercisers
Inclusion Criteria:
- Healthy men and women
- 25-55 years old
- Do not exercise on a regular basis
Exclusion Criteria:
Have not been diagnosed with hypertension, diabetes, high cholesterol, cardiovascular disease or asthma and other pulmonary disorders
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Thomas.Lang, PhD/Professor in Residence, UCSF |
| ClinicalTrials.gov Identifier: | NCT00835601 History of Changes |
| Other Study ID Numbers: | CCD Training Study, NSBRI BL-01301 |
| Study First Received: | January 29, 2009 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Muscular Atrophy Atrophy Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Pathological Conditions, Anatomical Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013