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A Randomized Exercise Trial for Wheelchair Users

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathleen Grobe, University of Kansas
ClinicalTrials.gov Identifier:
NCT00866112
First received: March 19, 2009
Last updated: June 13, 2012
Last verified: April 2010
History of Changes

March 19, 2009
June 13, 2012
May 2008
February 2011   (final data collection date for primary outcome measure)
Weekly minutes spent in aerobic and strengthening activity [ Time Frame: Baseline, 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00866112 on ClinicalTrials.gov Archive Site
 
 
 
 
 
A Randomized Exercise Trial for Wheelchair Users
A Randomized Exercise Trial for Wheelchair Users

People with mobility disabilities are at greater risk than the general population for incurring health problems. Many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. Recent evidence suggests that people with disabilities experience the same physiologic response to exercise as the general population. Nonetheless, nearly three-fourths of those with disabilities report being entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of issues that limit physical activity among this population, few studies have investigated methods for promoting physical activity adoption among people with disabilities, including wheelchair users. The purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual wheelchair users.
 
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Spinal Cord Injury
  • Multiple Sclerosis
  • Muscular Dystrophy
  • Cerebral Palsy
  • Spina Bifida
  • Amputation
  • Arthritis
  • Stroke
  • Other: Educational session to promote physical activity
    Educational session, goal setting, self monitoring of daily engagement in physical activity
  • Other: Minimal contact
    Self guided education manual about adopting physical activity, self monitor daily engagement in physical activity
  • Experimental: 1
    Intervention group to promote physical activity
    Intervention: Other: Educational session to promote physical activity
  • 2
    Minimal contact control group
    Intervention: Other: Minimal contact
Nary DE, Froehlich-Grobe K, Aaronson L. Recruitment issues in a randomized controlled exercise trial targeting wheelchair users. Contemp Clin Trials. 2011 Mar;32(2):188-95. Epub 2010 Oct 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
June 2012
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be experiencing a permanent disability of at least 6 months that limits mobility sufficiently to require use of a wheelchair as the primary method of mobility outside the home
  • Have not been moderately to vigorously physically active for the past 6 months
  • Be willing to attend the educational workshop
  • Receive physician approval for participation

Exclusion criteria include:

  • Presence of medical conditions such as uncontrolled cardiovascular problems that the patient's physician identifies as being contraindicated for exercise
  • Pregnancy or planning to become pregnant
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00866112
10053
No
Kathleen Grobe, University of Kansas
University of Kansas
 
Principal Investigator: Katherine Froehlich-Grobe, PhD University of Kansas
University of Kansas
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP