Clinical trial NCT01856231: Lifestyle Physical Activity for People With COPD
Official title: Lifestyle Physical Activity for People With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Physical activity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 54
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lifestyle physical activity self-efficacy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in physical activity measured by accelerometry
timeFrame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Secondary outcomes:
measure: Change in 6 minute walk test
timeFrame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
measure: Change in lower extremity function (Short Physical Performance Battery)
timeFrame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
measure: Change in dyspnea and fatigue (Pulmonary Functional Status and Dyspnea Questionnaire-Modified)
timeFrame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
measure: Change in physical activity measured by CHAMPS questionnaire
timeFrame: During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan - School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan - School of Nursing
name: Janet Larson, PhD
role: PRINCIPAL_INVESTIGATOR
References: