Active for Life: Chronic Obstructive Pulmonary Disease

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2022

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Active Life
    • The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
  • Sham Comparator: Chair exercises
    • The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Janet L. Larson, Shak√© Ketefian Collegiate Professor of Nursing – University of Michigan
  • Overall Official(s)
    • Janet L Larson, PhD, Principal Investigator, University of Michigan
  • Overall Contact(s)
    • She’Lon Tucker, BS, 734 936 3283, shehill@umich.edu

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