A Randomized Exercise Trial for Wheelchair Users

Stroke Clinical Trial

Official title:

A Randomized Exercise Trial for Wheelchair Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866112
• Other study ID #: 10053
• Status: Completed
• Phase: N/A
• First received: March 19, 2009
• Last updated: June 13, 2012
• Start date: May 2008
• Est. completion date: June 2012

Study information

• Verified date: April 2010
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Amputation
• Arthritis
• Cerebral Palsy
• Multiple Sclerosis
• Muscular Dystrophies
• Muscular Dystrophy
• Spina Bifida
• Spinal Cord Injuries
• Spinal Cord Injury
• Spinal Dysraphism
• Stroke

Intervention

Other:
• Educational session to promote physical activity
Educational session, goal setting, self monitoring of daily engagement in physical activity
• Minimal contact
Self guided education manual about adopting physical activity, self monitor daily engagement in physical activity

Locations

Country	Name	City	State
United States	University of Kansas	Lawrence	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly minutes spent in aerobic and strengthening activity		Baseline, 12, 26 and 52 weeks	No