Active for Life: Chronic Obstructive Pulmonary Disease (ActiveCOPD)

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: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Active Life; Behavioral: Chair exercises

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: Interventional
• Enrollment (Anticipated): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent in Physical Activity and sedentary behavior (baseline)	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.	7 days of data are gathered immediately before the beginning of the 10 week intervention
Time spent in Physical Activity and sedentary behavior (end of 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.	7 days of data are gathered following completion of the 10 week intervention
Time spent in Physical Activity and sedentary behavior (3 month follow-up)	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.	7 days of data are gathered 3 months after the completion of the 10 week intervention
Time spent in Physical Activity and sedentary behavior (6 month follow-up)	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.	7 days of data are gathered 6 months after the completion of the 10 week intervention
Time spent in Physical Activity and sedentary behavior (12 month follow-up)	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.	7 days of data are gathered 12 months after the completion of the 10 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test	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
Isometric strength (knee flexors and extensors)	This is measured in the seated position with a dynamometer.	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	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.	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	Short physical Performance Battery - includes a balance test, gait speed and chair stand	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

Outcome Measure	Measure Description	Time Frame
Chronic Respiratory Questionnaire Dyspnea Scale	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	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	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	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	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	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	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	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

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Janet L Larson, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2017
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; Chronic Obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: HUM00119545

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