Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 9, 2013
First Posted Date  ICMJE May 17, 2013
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE August 2011
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Physical Activity for People With COPD
Official Title  ICMJE Lifestyle Physical Activity for People With COPD
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Lifestyle physical activity self-efficacy
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 8 week group
Lifestyle physical activity self-efficacy
Intervention: Behavioral: Lifestyle physical activity - self-efficacy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2013)
50
Actual Study Completion Date  ICMJE July 1, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01856231
Other Study ID Numbers  ICMJE HUM00038130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janet L. Larson, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janet Larson, PhD University of Michigan - School of Nursing
PRS Account University of Michigan
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP