COPDNCT01856231
Lifestyle Physical Activity for People With COPD
A study testing Lifestyle physical activity - self-efficacy in people with COPD, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Lifestyle physical activity - self-efficacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 1 Jul 2017
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years or older
- Moderate to severe COPD (FEV1 < 80% and > 30% predicted; FEV1/FVC <70%) as the primary health problem
- Sedentary (less than 30 minutes of moderate activity 3 days/week)
Who cannot join
- No acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.
- No history of other major lung diseases as primary pulmonary problem, history of a recent heart attack or recent onset of chest pains with activity or increasing episodes of chest pain (unstable angina).
- No other health problems or mobility problems that limit physical activity.
- No child bearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan - School of Nursing
Ann Arbor, Michigan, 48109
About this study
The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a behavioral intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The subjects will be followed for a total of 18 weeks.
Read the detailed description
People with chronic obstructive pulmonary disease (COPD) experience a gradual decline in physical activity (PA). Exercise training in a structured pulmonary rehabilitation program can generate substantial gains in functional capacity, but increases in functional capacity do not necessarily lead to improvements in daily PA. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a self-efficacy enhancing intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The intervention gradually transitions subjects from the structured laboratory-based exercises that focus on walking and circuit training to fully integrated lifestyle physical activities that integrate structured home-based exercises and lifestyle physical activities into daily life. The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training and subjects will be followed for a total of 18 weeks.
- Conditions
- COPD
- Being tested
- Lifestyle physical activity - self-efficacy
- Keywords
- COPD, Physical activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle physical activity - self-efficacyBehavioural
Subjects will come into an exercise lab 2 days per week and perform 10-20 minutes of walking, 13 strength training exercises, stretching and a behavioral intervention including goal setting, etc.
| Study group | Role | What they receive |
|---|---|---|
| 8 week group | Experimental | Lifestyle physical activity self-efficacy Receives: Behavioral: Lifestyle physical activity - self-efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity measured by accelerometry
Subjects wear two activity monitors for seven consecutive days (Actipal and Actigraph). The study will compare the subject's activity level at the three time points listed.
Measured: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Secondary outcomes (4)
Change in 6 minute walk test
Subjects complete a 6 minute walk test measuring the total distance he/she can walk in 6 minutes at the three time points listed.
Measured: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in lower extremity function (Short Physical Performance Battery)
Subjects complete a performance test measuring balance, gait speed, and leg strength (using a chair stand test) at the three time points listed.
Measured: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in dyspnea and fatigue (Pulmonary Functional Status and Dyspnea Questionnaire-Modified)
Subjects complete a questionnaire answering questions about their level of dyspnea in various daily activities at the three time points listed.
Measured: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in physical activity measured by CHAMPS questionnaire
Subjects fill out a questionnaire of their perceived physical activity at the three time points listed.
Measured: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startAug 2011
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Model description
- Lifestyle physical activity self-efficacy
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet L. Larson, University of Michigan
- Investigators
- Janet Larson, PhD, Principal investigator, University of Michigan - School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856231
- Sponsor's protocol ID
- HUM00038130
- Status last verified
- Sep 2017
- First submitted
- 9 May 2013
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Physical Activity for People With COPD
- ClinicalTrials.gov ID
- NCT01856231
- Acronym / sponsor ID
- HUM00038130
- Conditions
- COPD
- Keywords
- COPD, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 17 May 2013 (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.
The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a behavioral intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The subjects will be followed for a total of 18 weeks.
Detailed description
People with chronic obstructive pulmonary disease (COPD) experience a gradual decline in physical activity (PA). Exercise training in a structured pulmonary rehabilitation program can generate substantial gains in functional capacity, but increases in functional capacity do not necessarily lead to improvements in daily PA. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a self-efficacy enhancing intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The intervention gradually transitions subjects from the structured laboratory-based exercises that focus on walking and circuit training to fully integrated lifestyle physical activities that integrate structured home-based exercises and lifestyle physical activities into daily life. The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training and subjects will be followed for a total of 18 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lifestyle physical activity self-efficacy
| Arm | Type | Receives |
|---|---|---|
| 8 week group | Experimental | Behavioral: Lifestyle physical activity - self-efficacyLifestyle physical activity self-efficacy |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 55 years or older
- Moderate to severe COPD (FEV1 < 80% and > 30% predicted; FEV1/FVC <70%) as the primary health problem
- Sedentary (less than 30 minutes of moderate activity 3 days/week)
Key exclusion criteria (4 listed)
- No acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.
- No history of other major lung diseases as primary pulmonary problem, history of a recent heart attack or recent onset of chest pains with activity or increasing episodes of chest pain (unstable angina).
- No other health problems or mobility problems that limit physical activity.
- No child bearing potential
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 |
|---|---|---|
| Lifestyle physical activity - self-efficacySubjects will come into an exercise lab 2 days per week and perform 10-20 minutes of walking, 13 strength training exercises, stretching and a behavioral intervention including goal setting, etc. | Behavioural | 8 week group |
Primary outcome
Change in physical activity measured by accelerometry
Time frame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Subjects wear two activity monitors for seven consecutive days (Actipal and Actigraph). The study will compare the subject's activity level at the three time points listed.
4 secondary outcomes
Change in 6 minute walk test
Time frame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in lower extremity function (Short Physical Performance Battery)
Time frame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in dyspnea and fatigue (Pulmonary Functional Status and Dyspnea Questionnaire-Modified)
Time frame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in physical activity measured by CHAMPS questionnaire
Time frame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
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 26 Sep 2017.
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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.
Janet Larson, PhD principal investigator
University of Michigan - School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle physical activity - self-efficacy in people with COPD, run by University of Michigan 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 4 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 26 Sep 2017. 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?
Change in physical activity measured by accelerometry (time frame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18). 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 26 Sep 2017.