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Self Efficacy, Walking Ability, Gait Speed and Physical Activity in People With Chronic Lung Disease

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ClinicalTrials.gov Identifier: NCT01583595
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Tracking Information
First Submitted Date February 7, 2012
First Posted Date April 24, 2012
Last Update Posted Date April 4, 2013
Study Start Date December 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2012)
Analyze associations between self-efficacy for walking, gait speed, physical activity level and perceptions of symptoms in patient with chronic lung disease (COPD and Pulmonary Fibrosis) [ Time Frame: Day of enrollment. ]
Correlation , regression models and mediation analysis (self efficacy and physical activity) will be performed.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01583595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 24, 2012)
Predictive utility of 4-meter gait speed for estimating physical activity level (PAL) as validated by gold standard activity monitor. [ Time Frame: 1 week ]
Measure 4-meter gait speed during standardized 6 mintute walk test and compare to armband activity monitor results to determine predictive ability, if any, on PAL in people with chronic lung disease.
Original Secondary Outcome Measures
 (submitted: April 23, 2012)
Predictive utility of 4-meter gait speed for estimating physical activity level (PAL) as validated by gold standard activity monitor. [ Time Frame: 1 week ]
Measure 4-meter gait speed during standardized 6MWT and compare to armband activity monitor results to determine predictive ability, if any, on PAL in people with chronic lung disease.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Self Efficacy, Walking Ability, Gait Speed and Physical Activity in People With Chronic Lung Disease
Official Title Determining the Relationships Between Self-efficacy for Walking Ability, Gate Speed and Physical Activity in Patients With Chronic Lung Disease
Brief Summary

Most patients with chronic lung disease underestimate their actual walking ability due to low confidence. To better understand the relationships between lung function, self-efficacy for walking (confidence in ability to walk a defined distance), actual walking ability for the same distance gait speed and physical activity level-PAL- (total energy expenditure/resting metabolic rate).

Quality of life, self efficacy for activity questionnaires, physical activity level measurement, 4-meter gait speed and 6-minute walk distance will be measured.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with chronic lung disease
Condition
  • Chronic Lung Disease
  • Self-efficacy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 24, 2012)
70
Original Estimated Enrollment
 (submitted: April 23, 2012)
150
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Men and women 40 years and older
  • Diagnosis of any chronic lung disease as evidenced by pulmonary function testing completed within the prior 12 months
  • Able to walk independently and successfully complete the 6-minute walk assessment

Exclusion Criteria:

  • Unable to walk without assistance or complete the 6-minute walk assessment
  • Patients unable to comprehend and accurately respond to the study questionnaires either by written or spoken communication
  • Patients diagnosed with or treated for a lower respiratory tract infection or COPD exacerbation within the prior 30 days
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01583595
Other Study ID Numbers 11-008157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Roberto P. Benzo, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Roberto P Benzo, M.D., MSc Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2013