Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis

NCT ID: NCT02600689

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-03-16

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Physical exercise training

Intervention Type: BEHAVIORAL

Cognitive exercise training

Cognitive, brain-training, video gaming \~30 minutes per session, 3 times per week for 12 weeks

Group Type: ACTIVE_COMPARATOR

Cognitive exercise training

Intervention Type: BEHAVIORAL

Interventions

Physical exercise training

Intervention Type: BEHAVIORAL

Cognitive exercise training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmonary Fibrosis Foundation

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

John D Lowman, PT, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hon K Yuen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Yuen HK, Lowman JD, Oster RA, de Andrade JA. Home-Based Pulmonary Rehabilitation for Patients With Idiopathic Pulmonary Fibrosis: A PILOT STUDY. J Cardiopulm Rehabil Prev. 2019 Jul;39(4):281-284. doi: 10.1097/HCR.0000000000000418.

Reference Type: DERIVED

PMID: 31241519 (View on PubMed)

Other Identifiers

PFF-378875

Identifier Type: -

Identifier Source: org_study_id