Clinical trial NCT02600689: Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
Official title: Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Pulmonary rehab
Exergame
Home-based
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Pulmonary Fibrosis Foundation
First posted: 2015-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Functional performance
timeFrame: 12 weeks
Secondary outcomes:
measure: Exercise dyspnea
timeFrame: 12 weeks
measure: 15-Step Test: Time
timeFrame: 12 weeks
measure: 15-Step Test: Exercise desaturation
timeFrame: 12 weeks
measure: 15-Step Test: Recovery
timeFrame: 12 weeks
measure: Physical activity level
timeFrame: 12 weeks
measure: Health-related quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Hon K Yuen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.