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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical exercise training
Cognitive exercise training
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Pulmonary rehab, Exergame, Home-based

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical exercise training

Cognitive exercise training

Arm Description

Combined aerobic and resistance exercise for 30 or more minutes at least 3 times per week for 12 weeks using the Wii Fit Plus

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

Outcomes

Primary Outcome Measures

Functional performance
6-min walk distance (m)

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2015
Last Updated
February 13, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
Pulmonary Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02600689
Brief Title
Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
Acronym
EXPLORE-IPF
Official Title
Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 16, 2018 (Actual)
Study Completion Date
March 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Pulmonary Fibrosis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Pulmonary rehab, Exergame, Home-based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise training
Arm Type
Experimental
Arm Description
Combined aerobic and resistance exercise for 30 or more minutes at least 3 times per week for 12 weeks using the Wii Fit Plus
Arm Title
Cognitive exercise training
Arm Type
Active Comparator
Arm Description
Cognitive, brain-training, video gaming ~30 minutes per session, 3 times per week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive exercise training
Primary Outcome Measure Information:
Title
Functional performance
Description
6-min walk distance (m)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Exercise dyspnea
Description
Dyspnea level (Borg CR10) after completing the 15-step test oximetry test
Time Frame
12 weeks
Title
15-Step Test: Time
Description
time (sec) to complete 15-step test
Time Frame
12 weeks
Title
15-Step Test: Exercise desaturation
Description
Level of desaturation (%) during 15-step test
Time Frame
12 weeks
Title
15-Step Test: Recovery
Description
Time to recovery to baseline oxygen saturation following 15-step test
Time Frame
12 weeks
Title
Physical activity level
Description
Time (min) spent per week in moderate-vigorous physical activity (assessed via an accelerometer)
Time Frame
12 weeks
Title
Health-related quality of life
Description
St George's Respiratory Questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hon K Yuen, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-1212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31241519
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.
Results Reference
derived

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Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis

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