Clinical trial NCT01107028: Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Official title: Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic pulmonary fibrosis
Dyspnea
Functional capacity
Quality of life
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-04-20
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Idiopathic pulmonary fibrosis, as defined by the American Thoracic Society Consensus Guidelines

Brief summary: Idiopathic pulmonary fibrosis (IPF) is a devastating disease marked by progressive lung scarring leading to multiple life-altering sequelae. The over-arching goals of the principal investigator's research program are to more fully characterize these sequelae and to examine interventions that might improve them. The hypotheses of this particular study are that pulmonary rehabilitation (PR) is one such intervention, and that PR will improve the sequelae of dyspnea and impairments in functional capacity, cognition, mood and anxiety, fatigue, and quality of life (QOL) in patients with IPF.

Detailed description: Subjects will come to our center to be enrolled. Baseline data collection (performance of a six-minute walk test and completion of questionnaires) and randomization to one of two groups--either Rehab or Wait--will take place at the same enrollment visit if time permits. Subjects in either group will complete pulmonary rehabilitation, just at slightly different times, depending on which group they are randomized to.

Pulmonary rehabilitation is a program run by respiratory and/or physical therapists and other health professionals that involves exercise, education, and support with the goals to improve functional capacity, symptom management, and well-being. It will last 6-8 weeks, during which time, subjects will complete 18 approximately hour-long sessions. Pulmonary rehabilitation may be completed at any local center that makes travel convenient.

Data collection visits will take place at National Jewish Health at baseline, eight weeks (without intervening pulmonary rehabilitation in the Wait group), after completion of pulmonary rehabilitation (time varies, depending on the randomization group), and finally six months after completion of the pulmonary rehabilitation program.

Eligibility criteria: Inclusion Criteria:

* Age \> 40 years
* IPF
* Able to walk unassisted for balance
* Able to speak and understand English well enough to complete complex tasks with directions given in English

Exclusion Criteria:

* Pulmonary fibrosis not due to IPF
* Coexisting comorbid conditions that would make exercise contraindicated

Primary outcomes:
measure: Six-minute walk distance
timeFrame: Eight weeks
Secondary outcomes:
measure: dyspnea, fatigue, anxiety, depression, quality of life
timeFrame: Eight weeks
measure: Six minute walk distance
timeFrame: Six months after completion of pulmonary rehabilitation
measure: dyspnea, fatigue, anxiety, depression, quality of life
timeFrame: Six months after completion of pulmonary rehabilitation
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Jeffrey J. Swigris, DO, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swigris JJ, Brown KK, Make BJ, Wamboldt FS. Pulmonary rehabilitation in idiopathic pulmonary fibrosis: a call for continued investigation. Respir Med. 2008 Dec;102(12):1675-80. doi: 10.1016/j.rmed.2008.08.014. Epub 2008 Oct 10.