Resistive/Cardiovascular Training Study (CCD)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00835601
First received: January 29, 2009
Last updated: May 13, 2011
Last verified: May 2011
  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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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
Study Population

Healthy men and women 25-55 years of age who are not exercisers

Criteria

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
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No Contacts or Locations Provided
  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 August 19, 2014