Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Other: Pulmonary rehabilitation program
- Registration Number
- NCT03717012
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objectives of this study are:
* Determine the difference in change from baseline in Six Minute Walk Distance (6MWD) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
* Determine the difference in change in Quality of Life (QoL) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
* Determine if there is an enduring effect in 6MWD, QoL and lung function from pulmonary rehabilitation (PR) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nintedanib with a pulmonary rehabilitation program Nintedanib - Nintedanib with a pulmonary rehabilitation program Pulmonary rehabilitation program - Nintedanib treatment alone Nintedanib -
- Primary Outcome Measures
Name Time Method Change From Baseline in the 6 Minute Walk Test (6MWD) at 12 Weeks Baseline (day 1) and week 12 (day 85). Absolute change from baseline in the 6 minute walk distance (6MWD) test at 12 weeks. The last assessment before treatment period start (included) will be used as baseline. If the baseline value is missing and the screening value is available, then the baseline value will be defined as the screening value taken closest to baseline date.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Total Score at 12 and 24 Weeks Baseline (day 1), week 12 (day 85) and week 24 (day 169). Absolute change from baseline in the St George's Respiratory Questionnaire (SGRQ) total score at 12 and 24 weeks. The SGRQ is a widely used disease specific questionnaire evaluating health related quality of life. The SGRQ Total Score is measured using patient self-reported question on disease impact on symptoms, patient activity, and daily life. SGRQ scores are calculated using weights attached to each item of the questionnaire which provides an estimate of the distress associated with the symptoms or state described in each item. The total score for SGRQ ranges from 0 to 100, with higher scores indicating more limitations.
Absolute Change From Baseline in The King's Brief Interstitial Lung Disease (KBILD) Questionnaire Total Score at 12 and 24 Weeks Baseline (day 1), week 12 (day 85) and week 24 (day 169). Absolute change from baseline in The King's Brief Interstitial Lung Disease (KBILD) questionnaire total score at 12 and 24 weeks. The KBILD questionnaire is a disease specific questionnaire evaluating health related quality of life. The questionnaire consists of 15 items. Raw total scores were weighted with a Likert response scale to create the total score, total scores were transformed to a range of 0-100 ((actual score-lowest possible score/range)\*100), with a score of 100 representing the best health status.
Change From Baseline in the University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Total Score at 12 and 24 Weeks Baseline (day 1), week 12 (day 85) and week 24 (day 169). Change from baseline in the University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) total score at 12 and 24 weeks. The UCSD-SOBQ is a 24-item questionnaire that assesses self-reported shortness of breath while performing a variety of activities of daily living, scores for each item range from 0 to 5, with higher scores indicating more limitations. Total score is calculated as the sum of all individual scores. Scores range from 0 to 120, with higher scores indicating more limitations.
Absolute Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks Baseline (day 1), week 12 (day 85) and week 24 (day 169). Absolute change from baseline of forced vital capacity (FVC) at 12 and 24 weeks. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Change From Baseline in the 6 Minute Walk Test (6MWD) at 24 Weeks Baseline (day 1) and week 24 (day 169). Absolute change from baseline in the 6 minute walk distance (6MWD) test at 24 weeks. The last assessment before treatment period start (included) will be used as baseline. If the baseline value is missing and the screening value is available, then the baseline value will be defined as the screening value taken closest to baseline date.
Relative Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks Baseline (day 1), week 12 (day 85) and week 24 (day 169). Relative change (unitless) from baseline of forced vital capacity (FVC) at 12 and 24 weeks. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured in milliliter (mL). Its relative change from baseline at 12 (24) weeks is calculated as: (FVC measured at 12 (24) weeks - FVC measured at baseline)/ FVC measured at baseline \*100%.
Absolute Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks Baseline (day 1), week 12 (day 85) and week 24 (day 169). Absolute change from baseline of forced vital capacity (FVC) % predicted at 12 and 24 weeks. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. For predicted normal values, different sites may use different prediction formulas, based on the method used to measure diffusing capacity of the lung for carbon monoxide (DLco). In any case, the method used must be in compliance with the European Respiratory Society (ERS)/American Thoracic Society (ATS) guideline on DLco measurements, and the prediction formula appropriate for that method.
Relative Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks Baseline (day 1), week 12 (day 85) and week 24 (day 169). Relative change (unitless) from baseline of forced vital capacity (FVC) % predicted at 12 and 24 weeks. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. For predicted normal values, different sites may use different prediction formulas, based on the method used to measure diffusing capacity of the lung for carbon monoxide (DLco). In any case, the method used must be in compliance with the European Respiratory Society (ERS)/American Thoracic Society (ATS) guideline on DLco measurements, and the prediction formula appropriate for that method. The relative change from baseline of FVC % predicted at 12 (24) weeks is calculated as: (FVC % Predicted measured at 12 (24) weeks - FVC % Predicted measured at baseline)/ FVC % Predicted measured at baseline \*100%.
Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Vector Magnitude Units (VMU)/Day Baseline (day 1), week 12 (day 85) and week 24 (day 169). Change from baseline in daily accelerometer activity from baseline at 12 and 24 weeks: Score of average vector magnitude units (VMU)/day. Categories were defined as follows:
VMU (daily VMU/min) 0 = 0 to 50 VMU/min
1. = 51 to 110 VMU/min
2. = 111 to 190 VMU/min
3. = 191 to 270 VMU/min
4. = 271 to 440 VMU/min
5. = \>441 VMU/minAbsolute Categorical Change of Forced Vital Capacity (FVC)% Predicted up to 12 and 24 Weeks (Decrease by >5%, Increase by >5%, and Change Within ≤5%) Baseline (day 1), week 12 (day 85) and week 24 (day 169). Absolute categorical change of forced vital capacity (FVC)% predicted up to 12 and 24 weeks, the following three categories were defined: decrease by \>5%, increase by \>5%, and change within ≤5%. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. For predicted normal values, different sites may use different prediction formulas, based on the method used to measure diffusing capacity of the lung for carbon monoxide (DLco). In any case, the method used must be in compliance with the European Respiratory Society (ERS)/American Thoracic Society(ATS) guideline on DLco measurements, and the prediction formula appropriate for that method.
Absolute Categorical Change of Forced Vital Capacity (FVC)% Predicted up to 12 and 24 Weeks (Decrease by >10%, Increase by >10%, and Change Within ≤10%) Baseline (day 1), week 12 (day 85) and week 24 (day 169). Absolute categorical change of forced vital capacity (FVC)% predicted up to 12 and 24 weeks, the following three categories were defined: decrease by \>10%, increase by \>10%, and change within ≤10%. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. For predicted normal values, different sites may use different prediction formulas, based on the method used to measure diffusing capacity of the lung for carbon monoxide (DLco). In any case, the method used must be in compliance with the European Respiratory Society (ERS)/American Thoracic Society(ATS) guideline on DLco measurements, and the prediction formula appropriate for that method.
Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Steps/Day Baseline (day 1), week 12 (day 85) and week 24 (day 169). Change from baseline in daily accelerometer activity from baseline at 12 and 24 weeks: Score of average Steps/day. Categories were defined as follows:
Steps (total daily value) 0 = 0 to 1900 steps/day
1. = 1901 to 3700 steps/day
2. = 3701 to 5500 steps/day
3. = 5501 to 7300 steps/day
4. = \>7301 steps/day
Trial Locations
- Locations (19)
The LaPorte County Institute for Clinical Research
🇺🇸Michigan City, Indiana, United States
Temple University Hospital
🇺🇸Oaks, Pennsylvania, United States
Metroplex Pul and Sleep Ctr
🇺🇸McKinney, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Coastal Pulmonary & Crit Care
🇺🇸Saint Petersburg, Florida, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Glacier View Research Institute
🇺🇸Kalispell, Montana, United States
Pulmonix, LLC
🇺🇸Greensboro, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Froedtert and The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
St. Vincent Physicians Sleep and Respiratory Center
🇺🇸Billings, Montana, United States
Pulmonary and Critical Care Associates of Baltimore
🇺🇸Towson, Maryland, United States
Miami VA Healthcare System
🇺🇸Miami, Florida, United States
Western Connecticut Medical Group
🇺🇸Danbury, Connecticut, United States