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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01583595
Other study ID # 11-008157
Secondary ID
Status Completed
Phase N/A
First received February 7, 2012
Last updated April 1, 2013
Start date December 2011
Est. completion date July 2012

Study information

Verified date March 2013
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Correlation , regression models and mediation analysis (self efficacy and physical activity) will be performed. Day of enrollment. No
Secondary Predictive utility of 4-meter gait speed for estimating physical activity level (PAL) as validated by gold standard activity monitor. 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. 1 week No
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