Lifestyle Physical Activity for People With COPD

The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a behavioral intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The subjects will be followed for a total of 18 weeks.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: Lifestyle physical activity - self-efficacy

Detailed Description

People with chronic obstructive pulmonary disease (COPD) experience a gradual decline in physical activity (PA). Exercise training in a structured pulmonary rehabilitation program can generate substantial gains in functional capacity, but increases in functional capacity do not necessarily lead to improvements in daily PA. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a self-efficacy enhancing intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The intervention gradually transitions subjects from the structured laboratory-based exercises that focus on walking and circuit training to fully integrated lifestyle physical activities that integrate structured home-based exercises and lifestyle physical activities into daily life. The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training and subjects will be followed for a total of 18 weeks.

• Study Type: Interventional
• Enrollment (Actual): 54
• 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: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 55 years or older
• Moderate to severe COPD (FEV1 < 80% and > 30% predicted; FEV1/FVC <70%) as the primary health problem
• Sedentary (less than 30 minutes of moderate activity 3 days/week)

Exclusion 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.
• No child bearing potential

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8 week group; Lifestyle physical activity self-efficacy	Behavioral: Lifestyle physical activity - self-efficacy; Subjects will come into an exercise lab 2 days per week and perform 10-20 minutes of walking, 13 strength training exercises, stretching and a behavioral intervention including goal setting, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity measured by accelerometry	Subjects wear two activity monitors for seven consecutive days (Actipal and Actigraph). The study will compare the subject's activity level at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 minute walk test	Subjects complete a 6 minute walk test measuring the total distance he/she can walk in 6 minutes at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in lower extremity function (Short Physical Performance Battery)	Subjects complete a performance test measuring balance, gait speed, and leg strength (using a chair stand test) at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in dyspnea and fatigue (Pulmonary Functional Status and Dyspnea Questionnaire-Modified)	Subjects complete a questionnaire answering questions about their level of dyspnea in various daily activities at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Change in physical activity measured by CHAMPS questionnaire	Subjects fill out a questionnaire of their perceived physical activity at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Janet Larson, PhD, University of Michigan - School of Nursing

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 9, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Physical activity
• Other Study ID Numbers: HUM00038130