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OpenTrials
Completed

NCT Number: NCT02399254

The Trajectory of Physical Activity Following Pulmonary Rehabilitation

Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical activity in the home and community settings is less clear. It may take a longer time for this increase in physical activity to occur. It has been stated in an editorial that it takes 3 months to train the muscles but 6 months to train the brain. The Investigators will first evaluate the change in physical activity following pulmonary rehabilitation using state-of-the-science motion detectors, then Investigators will follow the trajectory of physical activity over the next several months.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States

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About this study

This study will follow physical activity following pulmonary rehabilitation longitudinally over 48 weeks. Investigators will use a state-of-the-art accelerometer, to analyze minutes walking per day as the primary outcome, rather than vector magnitude units (VMU) or estimated steps per day. Investigators will explore potential factors influencing this important outcome, including baseline activity levels, demographic variables, changes in exercise capacity, psychological variables, and self-efficacy scores. Finally, Investigators will evaluate the rate of change (trajectory) in physical activity over approximately six months after pulmonary rehabilitation. There are limited data suggesting it takes time for the translation of increased exercise capacity into increased physical activity to occur.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (≥ 40 years) with a primary clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • A post-bronchodilator forced expiratory volume in one second(FEV1)/forced vital capacity (FVC) < 0.70 from spirometry performed within the preceding 12 months (no specific FEV1 percent-predicted requirement, although we anticipate the FEV1 will average around 45% of predicted, based on previous studies of pulmonary rehabilitation)
  • The patient was referred to pulmonary rehabilitation
  • The patient is clinically-stable: no exacerbation in preceding 4 weeks
  • Modified Medical Research Council (mMRC) dyspnea rating of at least 2 out of 5.

Exclusion criteria

  • Disease severity or co-morbidity that would make the patient be at-risk for participation this study
  • A significant movement disorder, such as hemiplegia, etc.
  • Inability to read and comprehend the questionnaires, which will be in English
  • A history of poor wound healing or chronic skin conditions that might predispose to local problems from wearing the DynaPort. (The DynaPort can be worn outside a thin garment, such as a tee shirt, and is relatively thin, without protruding parts. However, since the device may be worn overnight, and there is a remote risk of pressure problems, this exclusion criterion was added).

Treatment and study plan

Primary outcomes

  1. Minutes/Day at 12 Weeks

    Time frame: 12 weeks compared to baseline

    Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 12 ± 3 week assessment and baseline.

  2. Minutes/Day at 48 Weeks

    Time frame: 48 weeks compared to baseline

    Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 48 ± 3 week assessment and baseline.

Secondary outcomes

  1. Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks

    Time frame: 12 weeks compared to baseline

    Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 12 weeks compared to baseline

  2. Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks

    Time frame: 48 weeks compared to baseline

    Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 48 weeks compared to baseline

Sponsors and collaborators

Lead sponsor

Trinity Health Of New England

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2015
Registry last updated
Aug 6, 2019

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

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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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