NCT01583595

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 4, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

February 7, 2012

Last Update Submit

April 1, 2013

Conditions

Keywords

Chronic Lung DiseaseExerciseSelf-efficacy

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Predictive utility of 4-meter gait speed for estimating physical activity level (PAL) as validated by gold standard activity monitor.

    1 week

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with chronic lung disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Roberto P Benzo, M.D., MSc

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Pulmonary and Critical Care Medicine

Study Record Dates

First Submitted

February 7, 2012

First Posted

April 24, 2012

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 4, 2013

Record last verified: 2013-03

Locations