ClinicalTrials.gov
ClinicalTrials.gov Menu

Resistive/Cardiovascular Training Study (CCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00835601
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
University of California, San Francisco

Brief 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. 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 or disease
Muscular Atrophy

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Integrated Musculoskeletal Countermeasure Battery for Long-Duration Lunar Missions
Study Start Date : January 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011



Primary Outcome Measures :
  1. VO2max [ Time Frame: 6-12 weeks ]
  2. Leg Press Strength [ Time Frame: 6-12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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


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
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms