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OpenTrials
Completed

NCT Number: NCT02600689

Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis

Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention to improve physical function in patients with idiopathic pulmonary fibrosis (IPF). Of those individuals who complete phase 2 pulmonary rehab, only a small cohort continues with any type of maintenance exercise therapy (phase 3). This is largely due to personal factors, such as access to transportation, weather, scheduling difficulties, and cost.

Little is known about how to enhance physical activity among patients with IPF. In addition, no studies have investigated the long-term maintenance strategies of physical training in patients with IPF. Thus, the purpose of this study is to test the feasibility and effectiveness of a home-based, pulmonary rehab program for patients with IPF. A randomized, blinded, clinical trial (RCT) design with two arms -- Wii Fit Plus exergame program and cognitive video gaming, with no active whole body movement involved - will be used to investigate the benefits of a home-based exergame program on improving pulmonary-related function and symptoms in patients with IPF.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-1212, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed diagnosis of IPF based on the criteria of the American Thoracic Society/European Respiratory Society 2011 guidelines;
  • ≥ 40 years-of-age;
  • ambulatory without the use of an assistive device;
  • stable clinical condition (i.e., no pulmonary exacerbation for at least 6 weeks);
  • no changes in medication for at least 4 weeks before enrollment;
  • currently sedentary (i.e., exercise or participate in sports less than 3 times per week for 20 min in the past 6 months) and do not play any exergames;
  • report dyspnea on exertion leading to a limitation in performing daily activities (i.e., Medical Research Council (MRC) dyspnea grade >1);
  • able to read and follow exercise directions in English on the television screen;
  • have permission from their treating physician to participate in moderate-intensity exercise;
  • able to provide informed consent by understanding the nature of study participation.

Exclusion criteria

  • contraindication for moderate-intensity exercise (e.g., unstable cardiac disease),
  • severe musculoskeletal, vestibular, or neurological disorders limiting exercise performance, or inability to perform the 6-min walk test or 15-step test,
  • requires > 6 lpm supplemental oxygen therapy via nasal cannula during exercise to maintain SpO2 >88%;
  • MRC dyspnea grade 4 or 5; IPF patients with MRC dyspnea grade 4 or 5 have been reported to show little or no improvement, or deteriorated following pulmonary rehab;
  • stage 2 hypertension,
  • anemia (hemoglobin < 8 g/dL);
  • collagen vascular disease;
  • obstructive lung disease,
  • non-parenchymal restrictive lung disease,
  • occupational lung disease (pneumoconiosis, hypersensitivity pneumonitis),
  • sarcoidosis,
  • other idiopathic interstitial pneumonia;
  • currently participating or have participated (in the past 30 days) in another clinical trial which can affect the outcomes of the proposed study; or
  • planning to move out of Alabama within the next 6 months.

Treatment and study plan

Physical exercise training

Behavioral

Cognitive exercise training

Behavioral

Primary outcomes

  1. Functional performance

    Time frame: 12 weeks

    6-min walk distance (m)

Secondary outcomes

  1. Exercise dyspnea

    Time frame: 12 weeks

    Dyspnea level (Borg CR10) after completing the 15-step test oximetry test

  2. 15-Step Test: Time

    Time frame: 12 weeks

    time (sec) to complete 15-step test

  3. 15-Step Test: Exercise desaturation

    Time frame: 12 weeks

    Level of desaturation (%) during 15-step test

  4. 15-Step Test: Recovery

    Time frame: 12 weeks

    Time to recovery to baseline oxygen saturation following 15-step test

  5. Physical activity level

    Time frame: 12 weeks

    Time (min) spent per week in moderate-vigorous physical activity (assessed via an accelerometer)

  6. Health-related quality of life

    Time frame: 12 weeks

    St George's Respiratory Questionnaire

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Pulmonary Fibrosis Foundation

Registry information

Acronym: EXPLORE-IPF

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2015
Registry last updated
Feb 15, 2019

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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