Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis (EXPLORE-IPF)

February 13, 2019 updated by: John D Lowman, PT, PhD, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-1212
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Physical exercise training
Active Comparator: Cognitive exercise training
Cognitive, brain-training, video gaming ~30 minutes per session, 3 times per week for 12 weeks
Behavioral: Cognitive exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional performance
Time Frame: 12 weeks
6-min walk distance (m)
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Pulmonary Fibrosis Foundation

Investigators

  • Principal Investigator: Hon K Yuen, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFF-378875

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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