Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
EXPLORE-IPF
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2018
CompletedFebruary 15, 2019
February 1, 2019
2.6 years
November 5, 2015
February 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional performance
6-min walk distance (m)
12 weeks
Secondary Outcomes (6)
Exercise dyspnea
12 weeks
15-Step Test: Time
12 weeks
15-Step Test: Exercise desaturation
12 weeks
15-Step Test: Recovery
12 weeks
Physical activity level
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Physical exercise training
EXPERIMENTALCombined aerobic and resistance exercise for 30 or more minutes at least 3 times per week for 12 weeks using the Wii Fit Plus
Cognitive exercise training
ACTIVE COMPARATORCognitive, brain-training, video gaming \~30 minutes per session, 3 times per week for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Pulmonary Fibrosis Foundationcollaborator
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-1212, United States
Related Publications (1)
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.
PMID: 31241519DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hon K Yuen, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 9, 2015
Study Start
August 1, 2015
Primary Completion
March 16, 2018
Study Completion
March 16, 2018
Last Updated
February 15, 2019
Record last verified: 2019-02