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
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Multiple Sclerosis
Muscular Dystrophy
Cerebral Palsy
Spina Bifida
Amputation
Arthritis
Stroke
Other: Educational session to promote physical activity
Other: Minimal contact

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Exercise Trial for Wheelchair Users

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Weekly minutes spent in aerobic and strengthening activity [ Time Frame: Baseline, 12, 26 and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: May 2008
Study Completion Date: June 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intervention group to promote physical activity
Other: Educational session to promote physical activity
Educational session, goal setting, self monitoring of daily engagement in physical activity
2
Minimal contact control group
Other: Minimal contact
Self guided education manual about adopting physical activity, self monitor daily engagement in physical activity

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866112

Locations
United States, Kansas
University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Katherine Froehlich-Grobe, PhD University of Kansas
  More Information

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathleen Grobe, Assitant Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT00866112     History of Changes
Other Study ID Numbers: 10053
Study First Received: March 19, 2009
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Wheelchair use
Spinal cord injury
Multiple sclerosis
Muscular dystrophy
Cerebral palsy
Spina bifida
Amputation
Arthritis
Stroke

Additional relevant MeSH terms:
Spinal Dysraphism
Arthritis
Cerebral Palsy
Multiple Sclerosis
Muscular Dystrophies
Sclerosis
Spinal Cord Injuries
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Congenital Abnormalities
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Genetic Diseases, Inborn
Immune System Diseases
Joint Diseases
Muscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Nervous System Diseases
Nervous System Malformations
Neural Tube Defects
Neuromuscular Diseases
Pathologic Processes
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014