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Clinical Trials/NCT01856231
NCT01856231
Completed
Not Applicable

Lifestyle Physical Activity for People With COPD

University of Michigan1 site in 1 country54 target enrollmentAugust 2011
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
University of Michigan
Enrollment
54
Locations
1
Primary Endpoint
Change in physical activity measured by accelerometry
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
July 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Janet L. Larson

Professor

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in physical activity measured by accelerometry

Time Frame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18

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.

Secondary Outcomes

  • Change in dyspnea and fatigue (Pulmonary Functional Status and Dyspnea Questionnaire-Modified)(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(During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18)
  • Change in 6 minute walk test(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)(During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18)

Study Sites (1)

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