Chronic Lung DiseaseNCT01583595
Self Efficacy, Walking Ability, Gait Speed and Physical Activity in People With Chronic Lung Disease
An observational study of Chronic Lung Disease and Self-efficacy, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Lung Disease, Self-efficacy
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic lung disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Relationships Between Self-efficacy for Walking Ability, Gate Speed and Physical Activity in Patients With Chronic Lung Disease
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.
- Conditions
- Chronic Lung Disease, Self-efficacy
- Keywords
- Chronic Lung Disease, Exercise, Self-efficacy
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto P Benzo, M.D., MSc, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583595
- Sponsor's protocol ID
- 11-008157
- Status last verified
- Mar 2013
- First submitted
- 7 Feb 2012
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Relationships Between Self-efficacy for Walking Ability, Gate Speed and Physical Activity in Patients With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT01583595
- Acronym / sponsor ID
- 11-008157
- Conditions
- Chronic Lung Disease, Self-efficacy
- Keywords
- Chronic Lung Disease, Exercise, Self-efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic lung disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Predictive utility of 4-meter gait speed for estimating physical activity level (PAL) as validated by gold standard activity monitor.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Related trials for Chronic Lung Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto P Benzo, M.D., MSc principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lung Disease and Self-efficacy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.