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Active for Life: Chronic Obstructive Pulmonary Disease (ActiveCOPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201198
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Janet L. Larson, University of Michigan

Brief 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 activity and improve the health of people with chronic obstructive pulmonary disease.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: Active Life Behavioral: Chair exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Active for Life: Chronic Obstructive Pulmonary Disease
Actual Study Start Date : July 27, 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Time spent in Physical Activity and sedentary behavior (baseline) [ Time Frame: 7 days of data are gathered immediately before the beginning of the 10 week intervention ]
    The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.

  2. Time spent in Physical Activity and sedentary behavior (end of intervention) [ Time Frame: 7 days of data are gathered following completion of the 10 week intervention ]
    The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.

  3. Time spent in Physical Activity and sedentary behavior (3 month follow-up) [ Time Frame: 7 days of data are gathered 3 months after the completion of the 10 week intervention ]
    The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.

  4. Time spent in Physical Activity and sedentary behavior (6 month follow-up) [ Time Frame: 7 days of data are gathered 6 months after the completion of the 10 week intervention ]
    The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.

  5. Time spent in Physical Activity and sedentary behavior (12 month follow-up) [ Time Frame: 7 days of data are gathered 12 months after the completion of the 10 week intervention ]
    The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.


Secondary Outcome Measures :
  1. 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.

  2. Isometric strength (knee flexors and extensors) [ 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 measured in the seated position with a dynamometer.

  3. PROMIS Physical Function [ 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 ]
    PROMIS physical function scale - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low physical function and high scores indicate higher physical function.

  4. Short Physical Performance Battery [ 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 ]
    Short physical Performance Battery - includes a balance test, gait speed and chair stand


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201198


Locations
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United States, Michigan
University of Michigan School of Nursing
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Janet L Larson, PhD University of Michigan
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Responsible Party: Janet L. Larson, Shaké Ketefian Collegiate Professor of Nursing, University of Michigan
ClinicalTrials.gov Identifier: NCT03201198    
Other Study ID Numbers: HUM00119545
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janet L. Larson, University of Michigan:
physical activity
Chronic Obstructive Pulmonary Disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases