Trial record 9 of 33 for:
"Spina bifida"
A Randomized Exercise Trial for Wheelchair Users
This study has been completed.
Sponsor:
University of Kansas
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
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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:
MedlinePlus related topics:
Cerebral Palsy
Exercise and Physical Fitness
Multiple Sclerosis
Muscular Dystrophy
Paralysis
Spina Bifida
Spinal Cord Injuries
U.S. FDA Resources
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
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 Stroke Joint Diseases Musculoskeletal Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases Muscular Disorders, Atrophic Muscular Diseases Neuromuscular Diseases Genetic Diseases, Inborn Pathologic Processes Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013