Active for Life: Chronic Obstructive Pulmonary Disease (ActiveCOPD)

March 19, 2024 updated by: Janet L. Larson, University of Michigan
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Life
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Behavioral: Active Life
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.
Sham Comparator: Chair exercises
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Behavioral: Chair exercises
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
7 days of continuous activity monitoring at each interval

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
This is the maximal distance a subject can walk during six minutes.
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Chronic Respiratory Questionnaire Dyspnea Scale
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
Shortness of breath during physical activities. This is a 5-item scale and potential scores range from 5 - 35. Low scores reflect high levels of dyspnea and higher scores reflect lower levels of dyspnea.
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
PROMIS Fatigue
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
General experience of fatigue - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low fatigue and high scores indicate higher fatigue.
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
PROMIS Anxiety
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
General experience of anxious moods - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low anxiety and high scores indicate higher anxiety.
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
PROMIS Depression
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
General experience of depressed moods - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low depression and high scores indicate higher depression.
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Positive and Negative Social Influences on Physical Activity in Older Adults
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
Support from family and friends for being physically active. This questionnaire has a total of 27 items, 15 items describing positive social influence and 12 items describing negative social influence. The potential range of scores for positive social influence is 0 to 180 and the potential range of scores for negative social influence is 0 - 144.
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Self-Regulation for Physical Activity Scale
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
Measures goal setting, self-monitoring and other strategies for being physically active. This is a 12-item questionnaire and the potential range of scores is from 12 to 70. Higher scores indicate higher self-regulation.
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Barriers Efficacy for Physical Activity Scale: Chronic Obstructive Pulmonary Disease
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
This questionnaire has two scales, one that measures barriers efficacy for light physical activity (14 items) and one that measures barriers efficacy for moderate physical activity (14 items). The potential range of scores for each of the scales is 0% efficacy to 100% efficacy. Higher scores indicate a higher self-efficacy for overcoming barriers to physical activity.
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Multidimensional Outcomes Expectations Scale
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
This questionnaire measures peoples' beliefs or expectations about the benefits of regular exercise or light physical activity. It is a 15 item questionnaire and scores can range from 15-75. Higher scores indicate higher outcomes expectations for exercise
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Janet L Larson, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00119545
  • R01NR016093 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Active Life

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings