Chronic Obstructive Pulmonary DiseasePACCNCT01349608
Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Telephonic health coaching in people with Chronic Obstructive Pulmonary Disease and Physical Activity, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (COPD) become more physically active. Through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Physical Activity, Health Behavior
- What is being tested?
- Telephonic health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Mar 2013
- Phase
- Interventional
- 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
Who may be able to join
- Men and women age 40 years and older
- Current or former cigarette smoker of at least 10 pack-years
- Diagnosis of COPD stage II to IV COPD as documented by pulmonary function testing (FEV1 <80% predicted, FEV1/FVC ration <0.71) within the past 24 months
- Able to ambulate independently or with a walking aid (wheeled or standard walker or cane)
Who cannot join
- Unable to walk without assistance of another person
- patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not able to be contacted by telephone
- patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity Coaching in COPD
This study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (COPD) become more physically active. Through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity (emphasis on walking). The objective of the study is to determine if telephone-based health coaching is a reasonable and effective way to increase physical activity, as measured by a gold-standard activity monitor, in people with COPD.
- Being tested
- Telephonic health coaching
- Keywords
- Chronic Obstructive Pulmonary Disease, Motivational Interviewing, Health Coaching, Physical Activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic health coachingBehavioural
Participants will be given a pedometer and activity log to use daily to track their physical activity accomplishments. Weekly, they will participate in a health coaching telephone session to discuss physical activity and set goals. The health coach is knowledgable in COPD care and will utilize a motivational interviewing approach to support the self-efficacy of the participants to be more active.
| Study group | Role | What they receive |
|---|---|---|
| Health coaching | Experimental | Not described Receives: Behavioral: Telephonic health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of telephone-based health coaching in COPD.
Determine the effectiveness of a telephone-based health coaching intervention on daily physical activity level, as measured by a gold-standard activity monitor and daily pedometer record, acceptability of intervention through qualitative interviews with participants, and health-related quality of life as measured by questionnaires.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT01349608
- Sponsor's protocol ID
- 11-000356
- Acronym
- PACC
- Status last verified
- Apr 2013
- First submitted
- 2 May 2011
- 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
- Physical Activity Coaching in COPD
- ClinicalTrials.gov ID
- NCT01349608
- Acronym / sponsor ID
- PACC / 11-000356
- Keywords
- Chronic Obstructive Pulmonary Disease, Motivational Interviewing, Health Coaching, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 May 2011 (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.
This study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (COPD) become more physically active. Through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity (emphasis on walking). The objective of the study is to determine if telephone-based health coaching is a reasonable and effective way to increase physical activity, as measured by a gold-standard activity monitor, in people with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health coaching | Experimental | Behavioral: Telephonic health coaching |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women age 40 years and older
- Current or former cigarette smoker of at least 10 pack-years
- Diagnosis of COPD stage II to IV COPD as documented by pulmonary function testing (FEV1 <80% predicted, FEV1/FVC ration <0.71) within the past 24 months
- Able to ambulate independently or with a walking aid (wheeled or standard walker or cane)
Key exclusion criteria (3 listed)
- Unable to walk without assistance of another person
- patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not able to be contacted by telephone
- patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephonic health coachingParticipants will be given a pedometer and activity log to use daily to track their physical activity accomplishments. Weekly, they will participate in a health coaching telephone session to discuss physical activity and set goals. The health coach is knowledgable in COPD care and will utilize a motivational interviewing approach to support the self-efficacy of the participants to be more active. | Behavioural | Health coaching |
Primary outcome
Effectiveness of telephone-based health coaching in COPD.
Time frame: 3 Months
Determine the effectiveness of a telephone-based health coaching intervention on daily physical activity level, as measured by a gold-standard activity monitor and daily pedometer record, acceptability of intervention through qualitative interviews with participants, and health-related quality of life as measured by questionnaires.
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.
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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?
A study testing Telephonic health coaching in people with Chronic Obstructive Pulmonary Disease and Physical Activity, 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 4 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?
Effectiveness of telephone-based health coaching in COPD. (time frame: 3 Months). 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; AzTrials last refreshed its copy on 2 Nov 2026.