Active for Life: Chronic Obstructive Pulmonary Disease

NCT ID: NCT03201198

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-27
• Study Completion Date: 2023-01-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Active Life

The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.

Group Type: EXPERIMENTAL

Active Life

Intervention Type: BEHAVIORAL

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.

Chair exercises

The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.

Group Type: SHAM_COMPARATOR

Chair exercises

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Janet L. Larson

Shaké Ketefian Collegiate Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet L Larson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan School of Nursing

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01NR016093

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00119545

Identifier Type: -

Identifier Source: org_study_id