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Lifestyle Physical Activity for People With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856231
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Janet L. Larson, University of Michigan

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.

Condition or disease Intervention/treatment Phase
COPD Behavioral: Lifestyle physical activity - self-efficacy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Lifestyle physical activity self-efficacy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Physical Activity for People With COPD
Study Start Date : August 2011
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856231


Locations
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United States, Michigan
University of Michigan - School of Nursing
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Janet Larson, PhD University of Michigan - School of Nursing
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Responsible Party: Janet L. Larson, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01856231    
Other Study ID Numbers: HUM00038130
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Keywords provided by Janet L. Larson, University of Michigan:
COPD
Physical activity