Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis

Not Applicable

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Behavioral: Cognitive exercise training; Behavioral: Physical exercise training

• Registration Number: NCT02600689
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive exercise training	Cognitive exercise training	Cognitive, brain-training, video gaming \~30 minutes per session, 3 times per week for 12 weeks
Physical exercise training	Physical exercise training	Combined aerobic and resistance exercise for 30 or more minutes at least 3 times per week for 12 weeks using the Wii Fit Plus

Primary Outcome Measures

Name	Time	Method
Functional performance	12 weeks	6-min walk distance (m)

Secondary Outcome Measures

Name	Time	Method
15-Step Test: Time	12 weeks	time (sec) to complete 15-step test
Exercise dyspnea	12 weeks	Dyspnea level (Borg CR10) after completing the 15-step test oximetry test
15-Step Test: Recovery	12 weeks	Time to recovery to baseline oxygen saturation following 15-step test
Physical activity level	12 weeks	Time (min) spent per week in moderate-vigorous physical activity (assessed via an accelerometer)
15-Step Test: Exercise desaturation	12 weeks	Level of desaturation (%) during 15-step test
Health-related quality of life	12 weeks	St George's Respiratory Questionnaire

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States