NCT00866112

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 15, 2012

Status Verified

April 1, 2010

Enrollment Period

2.8 years

First QC Date

March 19, 2009

Last Update Submit

June 13, 2012

Conditions

Spinal Cord InjuryMultiple SclerosisMuscular DystrophyCerebral PalsySpina BifidaAmputationArthritisStroke

Keywords

Wheelchair useSpinal cord injuryMultiple sclerosisMuscular dystrophyCerebral palsySpina bifidaAmputationArthritisStroke

Outcome Measures

Primary Outcomes (1)

  • Weekly minutes spent in aerobic and strengthening activity

    Baseline, 12, 26 and 52 weeks

Study Arms (2)

1

EXPERIMENTAL

Intervention group to promote physical activity

Other: Educational session to promote physical activity

2

OTHER

Minimal contact control group

Other: Minimal contact

Interventions

Educational session to promote physical activityOTHER

Educational session, goal setting, self monitoring of daily engagement in physical activity

1
Minimal contactOTHER

Self guided education manual about adopting physical activity, self monitor daily engagement in physical activity

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (2)

  • Froehlich-Grobe K, Nary DE, VanSciver A, Washburn RA, Aaronson L. Truth be told: evidence of wheelchair users' accuracy in reporting their height and weight. Arch Phys Med Rehabil. 2012 Nov;93(11):2055-61. doi: 10.1016/j.apmr.2012.05.005. Epub 2012 May 15.

    PMID: 22609118DERIVED

  • 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. doi: 10.1016/j.cct.2010.10.010. Epub 2010 Oct 27.

    PMID: 21035565DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesMultiple SclerosisMuscular DystrophiesCerebral PalsySpinal DysraphismArthritisStroke

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain Damage, ChronicBrain DiseasesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesJoint DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Katherine Froehlich-Grobe, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

May 1, 2008

Primary Completion

February 1, 2011

Study Completion

June 1, 2012

Last Updated

June 15, 2012

Record last verified: 2010-04

Locations

US(1)