Chronic Obstructive Pulmonary DiseaseActiveCOPDNCT03201198
Active for Life: Chronic Obstructive Pulmonary Disease
A study testing Active Life and Chair exercises in people with Chronic Obstructive Pulmonary Disease, run by University of Michigan at 1 site in United States.
Trial summary
This study examines the effects of an exercise and behavioral program, called Active-Life, to promote physical activity in people with chronic obstructive pulmonary disease. A sedentary lifestyle is very common in older people with chronic disease and if this program is successful it will be used to promote physical… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Active Life and Chair exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
- Sedentary (less than 30 minutes of moderate activity 3 days/week)
Who cannot join
- Acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.
- 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).
- Other health problems or mobility problems that limit physical activity.
- Participated in a structured exercise program or pulmonary rehabilitation within the last year.
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
This study examines the effects of an exercise and behavioral program, called Active-Life, to promote physical activity in people with chronic obstructive pulmonary disease. A sedentary lifestyle is very common in older people with chronic disease and if this program is successful it will be used to promote physical activity and improve the health of people with chronic obstructive pulmonary disease.
Read the detailed description
Physical inactivity is a growing health problem in the United States, especially for older people with chronic diseases such as COPD; in fact people with COPD are among the least active. Low levels of physical activity (PA) are associated with negative health outcomes including an increase in mortality and COPD exacerbations. Current PA guidelines focus on moderate-to-vigorous physical activities (MVPAs) that are too strenuous and not feasible for long term maintenance in many people with COPD. The investigators propose a new paradigm for promoting PA in this population; focus on increasing time spent in light physical activity (LPA) and decreasing time spent in sedentary behavior. Growing evidence suggests that substantial health benefits are associated with increases in the volume of LPA. The investigators are testing the efficacy of the Active-for-Life (Active-Life) intervention. The central hypothesis is that Active-Life will have positive effects on objectively measured PA. Active-Life is a 10 week intervention designed to increase total PA with an emphasis on increasing the time spent in LPA and decreasing sedentary time. Active-Life establishes a goal for subjects, to increase total PA, combined LPA and MVPA, at least 60 minutes a day. This far exceeds the effects of other published PA interventions for people with COPD and if successful will advance PA science in clinically important ways. The Active-Life program was developed by Dr. Larson and through a series of preliminary studies; its feasibility is well established and preliminary data are promising. The investigators are conducting a randomized controlled trial comparing Active-Life against an active control. They will enroll 183 people with moderate to very severe COPD. Outcomes will be measured at baseline, end of the 10 week intervention and at 3, 6 and 12 months after the end of the intervention. The primary dependent variables are objectively measured PA and sedentary behavior, measured with ActivPAL and Actigraph accelerometers simultaneously. Secondary outcome measures are indicators of frailty: 6-minute distance walk, isometric strength of knee flexors and extensors, Short Physical Performance Battery and self-reported physical function. Potential mediators include barriers-efficacy for PA and outcome expectations for PA.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Active Life, Chair exercises
- Keywords
- physical activity, Chronic Obstructive Pulmonary Disease
- 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.
Active LifeBehavioural
The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
Chair exercisesBehavioural
Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Active Life | Experimental | The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components. Receives: Behavioral: Active Life |
| Chair exercises | Sham comparator | The Chair exercise intervention includes chair exercises, behavioral relaxation and health education. Receives: Behavioral: Chair exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor
The primary dependent variables are the time spent in physical activity (PA) as measured by Upright time monitored in each of the five intervals of the study over a 15-month period. PA will be measured for 7 consecutive days at each measurement using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
Measured: 7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5)
Time Spent in Sedentary Behavior
The primary dependent variable are the time spent in sedentary activity as measured as Sedentary Activity (SA) time monitored in each of the five intervals of the study over a 15-month period. SA will be measured for 7 consecutive days at each interval using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
Measured: 7 days of continuous activity monitoring at each interval
Secondary outcomes (1)
Six-minute Walk Test
This is the maximal distance a subject can walk during six minutes.
Measured: Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start27 Jul 2017
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Janet L. Larson, University of Michigan
- Investigators
- Janet L Larson, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201198
- Sponsor's protocol ID
- HUM00119545
- Other IDs
- R01NR016093
- Acronym
- ActiveCOPD
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2017
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this point the investigators have no plans to share IPD, but would consider a request to share deidentified data if it had the potential to advance science in the promotion of physical activity for older adults
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active for Life: Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03201198
- Acronym / sponsor ID
- ActiveCOPD / HUM00119545
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- physical activity, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effects of an exercise and behavioral program, called Active-Life, to promote physical activity in people with chronic obstructive pulmonary disease. A sedentary lifestyle is very common in older people with chronic disease and if this program is successful it will be used to promote physical activity and improve the health of people with chronic obstructive pulmonary disease.
Detailed description
Physical inactivity is a growing health problem in the United States, especially for older people with chronic diseases such as COPD; in fact people with COPD are among the least active. Low levels of physical activity (PA) are associated with negative health outcomes including an increase in mortality and COPD exacerbations. Current PA guidelines focus on moderate-to-vigorous physical activities (MVPAs) that are too strenuous and not feasible for long term maintenance in many people with COPD. The investigators propose a new paradigm for promoting PA in this population; focus on increasing time spent in light physical activity (LPA) and decreasing time spent in sedentary behavior. Growing evidence suggests that substantial health benefits are associated with increases in the volume of LPA. The investigators are testing the efficacy of the Active-for-Life (Active-Life) intervention. The central hypothesis is that Active-Life will have positive effects on objectively measured PA. Active-Life is a 10 week intervention designed to increase total PA with an emphasis on increasing the time spent in LPA and decreasing sedentary time. Active-Life establishes a goal for subjects, to increase total PA, combined LPA and MVPA, at least 60 minutes a day. This far exceeds the effects of other published PA interventions for people with COPD and if successful will advance PA science in clinically important ways. The Active-Life program was developed by Dr. Larson and through a series of preliminary studies; its feasibility is well established and preliminary data are promising. The investigators are conducting a randomized controlled trial comparing Active-Life against an active control. They will enroll 183 people with moderate to very severe COPD. Outcomes will be measured at baseline, end of the 10 week intervention and at 3, 6 and 12 months after the end of the intervention. The primary dependent variables are objectively measured PA and sedentary behavior, measured with ActivPAL and Actigraph accelerometers simultaneously. Secondary outcome measures are indicators of frailty: 6-minute distance walk, isometric strength of knee flexors and extensors, Short Physical Performance Battery and self-reported physical function. Potential mediators include barriers-efficacy for PA and outcome expectations for PA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Life | Experimental | Behavioral: Active LifeThe Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components. |
| Chair exercises | Sham comparator | Behavioral: Chair exercisesThe Chair exercise intervention includes chair exercises, behavioral relaxation and health education. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion 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.
- Sedentary (less than 30 minutes of moderate activity 3 days/week)
Key exclusion criteria (4 listed)
- Acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.
- 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).
- Other health problems or mobility problems that limit physical activity.
- Participated in a structured exercise program or pulmonary rehabilitation within the last year.
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 |
|---|---|---|
| Active LifeThe Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months. | Behavioural | Active Life |
| Chair exercisesChair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months. | Behavioural | Chair exercises |
Primary outcome
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor
Time frame: 7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5)
The primary dependent variables are the time spent in physical activity (PA) as measured by Upright time monitored in each of the five intervals of the study over a 15-month period. PA will be measured for 7 consecutive days at each measurement using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
Time Spent in Sedentary Behavior
Time frame: 7 days of continuous activity monitoring at each interval
The primary dependent variable are the time spent in sedentary activity as measured as Sedentary Activity (SA) time monitored in each of the five intervals of the study over a 15-month period. SA will be measured for 7 consecutive days at each interval using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
1 secondary outcome
Six-minute Walk Test
Time frame: Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. At this point the investigators have no plans to share IPD, but would consider a request to share deidentified data if it had the potential to advance science in the promotion of physical activity for older adults
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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 L Larson, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Life and Chair exercises in people with Chronic Obstructive Pulmonary Disease, 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 4 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 17 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor (time frame: 7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5)). The study lists 2 primary outcomes in all. 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 17 Apr 2024.