Active for Life: Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Chair exercises; Behavioral: Active Life

• Registration Number: NCT03201198
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-28
• Study Start: 2017-07-27
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Results First Submitted: 2024-01-29
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Results First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chair exercises	Chair exercises	The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Active Life	Active Life	The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.

Primary Outcome Measures

Name	Time	Method
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor	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	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)

Secondary Outcome Measures

Name	Time	Method
Six-minute Walk Test	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.

Trial Locations

Locations (1)

University of Michigan School of Nursing; 🇺🇸 Ann Arbor, Michigan, United States