Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— EXPLORE-IPF  

Official title:

Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600689
• Other study ID #: PFF-378875
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 16, 2018

Study information

• Verified date: February 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Behavioral:
• Physical exercise training

• Cognitive exercise training

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Pulmonary Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional performance	6-min walk distance (m)	12 weeks
Secondary	Exercise dyspnea	Dyspnea level (Borg CR10) after completing the 15-step test oximetry test	12 weeks
Secondary	15-Step Test: Time	time (sec) to complete 15-step test	12 weeks
Secondary	15-Step Test: Exercise desaturation	Level of desaturation (%) during 15-step test	12 weeks
Secondary	15-Step Test: Recovery	Time to recovery to baseline oxygen saturation following 15-step test	12 weeks
Secondary	Physical activity level	Time (min) spent per week in moderate-vigorous physical activity (assessed via an accelerometer)	12 weeks
Secondary	Health-related quality of life	St George's Respiratory Questionnaire	12 weeks