Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107028
• Other study ID #: NJ230
• Secondary ID: K23HL092227-01A2
• Status: Completed
• Start date: February 2010
• Est. completion date: October 2014

Study information

• Verified date: October 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• Standard pulmonary rehabilitation program
At the assigned time, subjects will complete a six-week, outpatient pulmonary rehabilitation program at any local center that has such a program.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk distance	Distance walked during a standard six-minute walk test.	Eight weeks
Secondary	dyspnea, fatigue, anxiety, depression, quality of life		Eight weeks
Secondary	Six minute walk distance		Six months after completion of pulmonary rehabilitation
Secondary	dyspnea, fatigue, anxiety, depression, quality of life		Six months after completion of pulmonary rehabilitation

External Links

•   National Jewish website information for this study