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Completed

NCT Number: NCT01856231

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan - School of Nursing

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle physical activity - self-efficacy

Behavioral

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.

Primary outcomes

  1. 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

  1. Change in 6 minute walk test

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

    Subjects complete a 6 minute walk test measuring the total distance he/she can walk in 6 minutes at the three time points listed.

  2. Change in lower extremity function (Short Physical Performance Battery)

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

    Subjects complete a performance test measuring balance, gait speed, and leg strength (using a chair stand test) at the three time points listed.

  3. Change in dyspnea and fatigue (Pulmonary Functional Status and Dyspnea Questionnaire-Modified)

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

    Subjects complete a questionnaire answering questions about their level of dyspnea in various daily activities at the three time points listed.

  4. Change in physical activity measured by CHAMPS questionnaire

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

    Subjects fill out a questionnaire of their perceived physical activity at the three time points listed.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 17, 2013
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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