Lung Diseases, InterstitialActigraphyNCT05866198
Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
A study testing Actigraph CP Insight Watch in people with Lung Diseases, Interstitial, run by University of South Florida at 1 site in United States.
Trial summary
The planned study is a prospective cohort interventional study in IPF and PF-ILD patients after initiating anti-fibrotic therapy and pulmonary rehabilitation. The study aims to investigate if accelerometer measured PA parameters, such as total daily steps, moderate-vigorous PA demonstrate significant and sustained… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Actigraph CP Insight Watch
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to May 2026
- 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
- Recently diagnosed (within 24 months) patients with PF-ILD, including IPF, as defined in the 'study population'
- Patients of 40 years and above and MMRC functional class II or higher
- Patients willing to provide consent and comply with study procedures
- Patient agrees to complete pulmonary rehabilitation program during the study period
- Patient must be antifibrotic naïve or on antifibrotic therapy for less than three months. To be included into the trial, the participant must be on a stable dose of immunosuppressants (for underlying disease causing ILD) and/or antifibrotic therapy for at least 30 days prior to enrollment.
- Subjects must be able to walk >150 meters in their screening 6MWT
- FVC ≥ 40% of predicted and DLco between 30% to 80% of predicted
Who cannot join
- PF-ILD including IPF patients who have already completed pulmonary rehabilitation within a year.
- Patients with acute exacerbation or active lung infection within 3 months prior to screening
- PF-ILD including IPF patients who are already receiving antifibrotic therapy for more than six months.
- Patients with significant pulmonary hypertension (PH)- defined as previous clinical or echocardiographic evidence of significant right heart failure, history of right heart catheterization showing cardiac index ≤ 2 l/min/m2 and PH requiring parenteral therapy with epoprostenol or Treprostinil.
- Metastatic malignancy under active treatment or active malignancy which would affect mobility
- Presence of concomitant severe or very severe chronic obstructive pulmonary disease (COPD) by ATS criteria.17 Mild to moderate cases will be included into the study.
Show all 22Show fewer
- Presence of significant emphysema in CT scan of chest as determined by the study investigator
- PF-ILD patients who have limited mobility as a result of their underlying autoimmune disease
- Severe fatigue in sarcoidosis patients with fatigue associated sarcoidosis (FAS) score ≥ 35
- Patients requiring full-dose systemic anticoagulation, or with any other contraindication to nintedanib use
- Patients with active and symptomatic coronary artery disease
- Morbid obesity, defined as BMI>35
- Symptomatic moderate to severe valvular heart disease
- Known NYHA class-III heart disease or echocardiographic left ventricular ejection fraction ≤ 40%
- Inability to maintain oxygen saturation >88% with physical exertion despite supplemental oxygen
- Inability to ambulate for any reason
- Inability or unwilling to perform the required tests
- Presence of any other condition, that in the judgement of investigators may interfere with trial participation or may put the patient at risk when participating in the trial during the entire trial period.
- Women of childbearing potential will be advised to avoid becoming pregnant while receiving treatment with nintedanib and to use highly effective contraceptive methods at initiation of, during and at least 3 months after the last dose of nintedanib. Those patients who refuse to comply with abovementioned advice would be excluded from participating in the trial.
- Patient with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.
- Patients with signs and symptoms of acute myocardial ischemia.
- Patients with arterial thromboembolic events, known risk of bleeding and gastrointestinal perforation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida/ Tampa General Hospital
Tampa, Florida, 33606
Rachel A Karlnoski, PhD, 727-858-4224, karlnosk@usf.edu
About this study
Official title: Evaluation of Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
The planned study is a prospective cohort interventional study in IPF and PF-ILD patients after initiating anti-fibrotic therapy and pulmonary rehabilitation. The study aims to investigate if accelerometer measured PA parameters, such as total daily steps, moderate-vigorous PA demonstrate significant and sustained changes longitudinally from baseline in this cohort and can predict disease progression. The study also explores if the actigraphic PA indices correlate with patients' quality of life, change in six-minute walk distance (6MWD), GAP score, fatigue score, change in patients' dyspnea score/scale, radiographic extent of the disease, and pulmonary function test parameters.
The study is exploratory in nature. It will provide vital information for clinical as well as research purposes. Clinically, accelerometer measured PA can be utilized for therapeutic target and prognostication, helping to develop patient centric care. The measured indices can also be useful to serve as meaningful endpoints to plan larger and definitive studies in IPF and PF-ILD patients.
Read the detailed description
This is a 52-week prospective cohort study, involving IPF and PF-ILD patients. Those IPF and PF-ILD patients fulfilling inclusion criteria without meeting exclusion criteria will be considered for the study.
An IPF diagnosis will be confirmed according to ATS/ERS/JRS/ALAT 2018 criteria. Other PF-ILD diagnoses will be confirmed using standard diagnostic criteria by PI. In case of diagnostic uncertainty, the study PI and sub-PI may be consulted for consensus. All subjects will be over the age of 40 years and of either sex.
We will identify potential subjects from the ILD clinic at Tampa General Hospital. All consented subjects will have the following measurements recorded as part of their routine clinical assessment and standard of care: medical history, MMRC dyspnea scale, pulmonary function test (spirometry, lung volume and DLco), serum liver functions test, high resolution CT scan of chest and a 6MWT. The sarcoidosis-PF patients will fill out a FAS questionnaire, in addition. The study participants will complete the L-PF (L-PF symptoms and L-PF impacts), k-BILD, and FSS questionnaires. GAP index will be calculated. If indicated, echocardiogram and/or right heart catheterization will be performed.
The 6MWT will be performed following guidelines for the Boehringer-Ingelheim 1199.187 IPF trial. The document is enclosed along with this submission.
Following initial evaluation and baseline questionnaires, all participants will be provided an actigraphy watch (CP Insight Watch, Actigraph LLC, Pensacola, FL) which will be worn on the wrist for seven continuous days and participants will be encouraged to wear it for 24 hours a day. Actigraphy data will be monitored remotely via bluetooth and will be downloaded using the manufacturer's provided software.
After completing seven days of baseline actigraphy assessment (this is the usual timeline to obtain prescription), treatment naïve subjects will begin nintedanib, 150 mg twice daily as per standard of care (SoC). Subjects already on nintedanib for less than three months and on stable dosing for at least a month, will continue their current regimen. All subjects will receive other treatments as per SoC, including immunosuppression and/or oxygen supplementation as needed. All participants will be enrolled in a standardized pulmonary rehabilitation program.
Evaluations and follow-up will be scheduled at week 0, 12, 24, 36, and 52. The first 7 days after enrollment, during the baseline actigraphy assessment, will count as week 0. At each of these visits, participants will wear an actigraphy watch (CP Insight Watch, Actigraph LLC, Pensacola, FL) on the wrist for seven continuous days and participants will be encouraged to wear it for 24 hours a day. Actigraphy data will be monitored remotely via bluetooth and will be downloaded using the manufacturer's provided software.
Thereafter, accelerometer reported PA indices will be measured for 7 continuous days at week 12, 24, 36, and 52.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Actigraph CP Insight Watch
- Keywords
- Progressive phenotype, anti-fibrotic therapy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actigraph CP Insight WatchDiagnostic test
CP Insight Watch (Actigraph, Pensacola, FL) is usually worn on the wrist. The watch captures and records continuous high-resolution raw acceleration data to provide objective, real-world physical activity, mobility, and sleep measures, in near real time. That data is then processed by ActiLife software into what is called Epoch data (i.e. turning it into activity counts so that things such as moderate vigorous physical activity can be found). The device also passively scores every minute of recorded data as "Sleep" or "Wake" based on the amount of activity taking place.
What is being measured
The primary outcome is the main question the study is designed to answer.
change in six-minute walk distance from baseline to 52 weeks
The 6-minute walk test (6MWT) is an assessment that a doctor may use to determine a person's exercise tolerance. It is a low risk test that measures how far a person can walk in 6 minutes.
Measured: baseline to 52 weeks
Secondary outcomes (1)
Change in Accelerometer Measurements
Although participants are expected to wear the actigraphy watch 24 hours/day for seven days, to be included in the final analysis, the device (accelerometer) must be able to capture data for at least five of the seven valid days. A minimum of 10-12 hours of wear time in a day will constitute a valid day. The following parameters will be obtained from the accelerometer: SPD, percentage of time spend sedentary to total time, total sleep time per day, average daily activity time, daily time spent in minutes in non-sedentary activity which is higher than 100 activity per minute, number of MVPA bouts of at least 10 minutes duration, MVPA as percentage of total time.
Measured: From baseline to Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Sep 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, observational, single arm
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866198
- Sponsor's protocol ID
- STUDY003811
- Acronym
- Actigraphy
- Status last verified
- Dec 2023
- First submitted
- 10 May 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential data and PHI will not be disclosed outside of the study team except as required by law or as allowed by the consent (e.g. with the USF IRB or those who monitor the study.)
Publications
Raghu G, Collard HR, Anstrom KJ, Flaherty KR, Fleming TR, King TE Jr, Martinez FJ, Brown KK. Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. Am J Respir Crit Care Med. 2012 May 15;185(10):1044-8. doi: 10.1164/rccm.201201-0006PP. Epub 2012 Apr 13.
PubMed 22505745Sgalla G, Biffi A, Richeldi L. Idiopathic pulmonary fibrosis: Diagnosis, epidemiology and natural history. Respirology. 2016 Apr;21(3):427-37. doi: 10.1111/resp.12683. Epub 2015 Nov 23.
PubMed 26595062Root ED, Graney B, Baird S, Churney T, Fier K, Korn M, McCormic M, Sprunger D, Vierzba T, Wamboldt FS, Swigris JJ. Physical activity and activity space in patients with pulmonary fibrosis not prescribed supplemental oxygen. BMC Pulm Med. 2017 Nov 23;17(1):154. doi: 10.1186/s12890-017-0495-2.
PubMed 29169394Bahmer T, Kirsten AM, Waschki B, Rabe KF, Magnussen H, Kirsten D, Gramm M, Hummler S, Brunnemer E, Kreuter M, Watz H. Clinical Correlates of Reduced Physical Activity in Idiopathic Pulmonary Fibrosis. Respiration. 2016;91(6):497-502. doi: 10.1159/000446607. Epub 2016 Jun 1.
PubMed 27240427
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT05866198
- Acronym / sponsor ID
- Actigraphy / STUDY003811
- Conditions
- Lung Diseases, Interstitial
- Keywords
- Progressive phenotype, anti-fibrotic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 19 May 2023 (actual)
- 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.
The planned study is a prospective cohort interventional study in IPF and PF-ILD patients after initiating anti-fibrotic therapy and pulmonary rehabilitation. The study aims to investigate if accelerometer measured PA parameters, such as total daily steps, moderate-vigorous PA demonstrate significant and sustained changes longitudinally from baseline in this cohort and can predict disease progression. The study also explores if the actigraphic PA indices correlate with patients' quality of life, change in six-minute walk distance (6MWD), GAP score, fatigue score, change in patients' dyspnea score/scale, radiographic extent of the disease, and pulmonary function test parameters.
The study is exploratory in nature. It will provide vital information for clinical as well as research purposes. Clinically, accelerometer measured PA can be utilized for therapeutic target and prognostication, helping to develop patient centric care. The measured indices can also be useful to serve as meaningful endpoints to plan larger and definitive studies in IPF and PF-ILD patients.
Detailed description
This is a 52-week prospective cohort study, involving IPF and PF-ILD patients. Those IPF and PF-ILD patients fulfilling inclusion criteria without meeting exclusion criteria will be considered for the study.
An IPF diagnosis will be confirmed according to ATS/ERS/JRS/ALAT 2018 criteria. Other PF-ILD diagnoses will be confirmed using standard diagnostic criteria by PI. In case of diagnostic uncertainty, the study PI and sub-PI may be consulted for consensus. All subjects will be over the age of 40 years and of either sex.
We will identify potential subjects from the ILD clinic at Tampa General Hospital. All consented subjects will have the following measurements recorded as part of their routine clinical assessment and standard of care: medical history, MMRC dyspnea scale, pulmonary function test (spirometry, lung volume and DLco), serum liver functions test, high resolution CT scan of chest and a 6MWT. The sarcoidosis-PF patients will fill out a FAS questionnaire, in addition. The study participants will complete the L-PF (L-PF symptoms and L-PF impacts), k-BILD, and FSS questionnaires. GAP index will be calculated. If indicated, echocardiogram and/or right heart catheterization will be performed.
The 6MWT will be performed following guidelines for the Boehringer-Ingelheim 1199.187 IPF trial. The document is enclosed along with this submission.
Following initial evaluation and baseline questionnaires, all participants will be provided an actigraphy watch (CP Insight Watch, Actigraph LLC, Pensacola, FL) which will be worn on the wrist for seven continuous days and participants will be encouraged to wear it for 24 hours a day. Actigraphy data will be monitored remotely via bluetooth and will be downloaded using the manufacturer's provided software.
After completing seven days of baseline actigraphy assessment (this is the usual timeline to obtain prescription), treatment naïve subjects will begin nintedanib, 150 mg twice daily as per standard of care (SoC). Subjects already on nintedanib for less than three months and on stable dosing for at least a month, will continue their current regimen. All subjects will receive other treatments as per SoC, including immunosuppression and/or oxygen supplementation as needed. All participants will be enrolled in a standardized pulmonary rehabilitation program.
Evaluations and follow-up will be scheduled at week 0, 12, 24, 36, and 52. The first 7 days after enrollment, during the baseline actigraphy assessment, will count as week 0. At each of these visits, participants will wear an actigraphy watch (CP Insight Watch, Actigraph LLC, Pensacola, FL) on the wrist for seven continuous days and participants will be encouraged to wear it for 24 hours a day. Actigraphy data will be monitored remotely via bluetooth and will be downloaded using the manufacturer's provided software.
Thereafter, accelerometer reported PA indices will be measured for 7 continuous days at week 12, 24, 36, and 52.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Prospective, observational, single arm
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Recently diagnosed (within 24 months) patients with PF-ILD, including IPF, as defined in the 'study population'
- Patients of 40 years and above and MMRC functional class II or higher
- Patients willing to provide consent and comply with study procedures
- Patient agrees to complete pulmonary rehabilitation program during the study period
- Patient must be antifibrotic naïve or on antifibrotic therapy for less than three months. To be included into the trial, the participant must be on a stable dose of immunosuppressants (for underlying disease causing ILD) and/or antifibrotic therapy for at least 30 days prior to enrollment.
Key exclusion criteria (22 listed)
- PF-ILD including IPF patients who have already completed pulmonary rehabilitation within a year.
- Patients with acute exacerbation or active lung infection within 3 months prior to screening
- PF-ILD including IPF patients who are already receiving antifibrotic therapy for more than six months.
- Patients with significant pulmonary hypertension (PH)- defined as previous clinical or echocardiographic evidence of significant right heart failure, history of right heart catheterization showing cardiac index ≤ 2 l/min/m2 and PH requiring parenteral therapy with epoprostenol or Treprostinil.
- Metastatic malignancy under active treatment or active malignancy which would affect mobility
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 |
|---|---|---|
| Actigraph CP Insight WatchCP Insight Watch (Actigraph, Pensacola, FL) is usually worn on the wrist. The watch captures and records continuous high-resolution raw acceleration data to provide objective, real-world physical activity, mobility, and sleep measures, in near real time. That data is then processed by ActiLife software into what is called Epoch data (i.e. turning it into activity counts so that things such as moderate vigorous physical activity can be found). The device also passively scores every minute of recorded data as "Sleep" or "Wake" based on the amount of activity taking place. | Diagnostic test | – |
Primary outcome
change in six-minute walk distance from baseline to 52 weeks
Time frame: baseline to 52 weeks
The 6-minute walk test (6MWT) is an assessment that a doctor may use to determine a person's exercise tolerance. It is a low risk test that measures how far a person can walk in 6 minutes.
1 secondary outcome
Change in Accelerometer Measurements
Time frame: From baseline to Day 7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 22505745Raghu G, Collard HR, Anstrom KJ, Flaherty KR, Fleming TR, King TE Jr, Martinez FJ, Brown KK. Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. Am J Respir Crit Care Med. 2012 May 15;185(10):1044-8. doi: 10.1164/rccm.201201-0006PP. Epub 2012 Apr 13.
- Background: PubMed 26595062Sgalla G, Biffi A, Richeldi L. Idiopathic pulmonary fibrosis: Diagnosis, epidemiology and natural history. Respirology. 2016 Apr;21(3):427-37. doi: 10.1111/resp.12683. Epub 2015 Nov 23.
- Background: PubMed 29169394Root ED, Graney B, Baird S, Churney T, Fier K, Korn M, McCormic M, Sprunger D, Vierzba T, Wamboldt FS, Swigris JJ. Physical activity and activity space in patients with pulmonary fibrosis not prescribed supplemental oxygen. BMC Pulm Med. 2017 Nov 23;17(1):154. doi: 10.1186/s12890-017-0495-2.
- Background: PubMed 27240427Bahmer T, Kirsten AM, Waschki B, Rabe KF, Magnussen H, Kirsten D, Gramm M, Hummler S, Brunnemer E, Kreuter M, Watz H. Clinical Correlates of Reduced Physical Activity in Idiopathic Pulmonary Fibrosis. Respiration. 2016;91(6):497-502. doi: 10.1159/000446607. Epub 2016 Jun 1.
- Individual participant dataSharing planned: No. Confidential data and PHI will not be disclosed outside of the study team except as required by law or as allowed by the consent (e.g. with the USF IRB or those who monitor the study.)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraph CP Insight Watch in people with Lung Diseases, Interstitial, run by University of South Florida 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 7 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Diaz, MPH (813-396-2373, luisd2@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in six-minute walk distance from baseline to 52 weeks (time frame: baseline to 52 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 NCT05866198, which also lists 4 linked publications.
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 Dec 2023.