Idiopathic Pulmonary FibrosisEXPLORE-IPFNCT02600689
Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
A study testing Physical exercise training and Cognitive exercise training in people with Idiopathic Pulmonary Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Physical exercise training and Cognitive exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 16 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-1212
About this study
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
- Being tested
- Physical exercise training, Cognitive exercise training
- Keywords
- Pulmonary rehab, Exergame, Home-based
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise trainingBehavioural
Cognitive exercise trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise training | Experimental | Combined aerobic and resistance exercise for 30 or more minutes at least 3 times per week for 12 weeks using the Wii Fit Plus Receives: Behavioral: Physical exercise training |
| Cognitive exercise training | Active comparator | Cognitive, brain-training, video gaming ~30 minutes per session, 3 times per week for 12 weeks Receives: Behavioral: Cognitive exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance
6-min walk distance (m)
Measured: 12 weeks
Secondary outcomes (6)
Exercise dyspnea
Dyspnea level (Borg CR10) after completing the 15-step test oximetry test
Measured: 12 weeks
15-Step Test: Time
time (sec) to complete 15-step test
Measured: 12 weeks
15-Step Test: Exercise desaturation
Level of desaturation (%) during 15-step test
Measured: 12 weeks
15-Step Test: Recovery
Time to recovery to baseline oxygen saturation following 15-step test
Measured: 12 weeks
Physical activity level
Time (min) spent per week in moderate-vigorous physical activity (assessed via an accelerometer)
Measured: 12 weeks
Health-related quality of life
St George's Respiratory Questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startAug 2015
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Pulmonary Fibrosis Foundation
- Responsible party
- Principal investigator, John D Lowman, PT, PhD, University of Alabama at Birmingham
- Investigators
- Hon K Yuen, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600689
- Sponsor's protocol ID
- PFF-378875
- Acronym
- EXPLORE-IPF
- Status last verified
- Feb 2019
- First submitted
- 5 Nov 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31241519
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02600689
- Acronym / sponsor ID
- EXPLORE-IPF / PFF-378875
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Pulmonary rehab, Exergame, Home-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Pulmonary Fibrosis Foundation
- Study start
- Aug 2015
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical exercise training | Experimental | Behavioral: Physical exercise trainingCombined 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 comparator | Behavioral: Cognitive exercise trainingCognitive, brain-training, video gaming ~30 minutes per session, 3 times per week for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise training | Behavioural | Physical exercise training |
| Cognitive exercise training | Behavioural | Cognitive exercise training |
Primary outcome
Functional performance
Time frame: 12 weeks
6-min walk distance (m)
6 secondary outcomes
Exercise dyspnea
Time frame: 12 weeks
15-Step Test: Time
Time frame: 12 weeks
15-Step Test: Exercise desaturation
Time frame: 12 weeks
15-Step Test: Recovery
Time frame: 12 weeks
Physical activity level
Time frame: 12 weeks
Health-related quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 31241519Yuen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hon K Yuen, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise training and Cognitive exercise training in people with Idiopathic Pulmonary Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional performance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.