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OpenTrials
Completed

NCT Number: NCT01107028

Beneficial Effects of Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Dyspnea Lung Diseases Lung Diseases, Interstitial Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard pulmonary rehabilitation program

Other

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

Primary outcomes

  1. Six-minute walk distance

    Time frame: Eight weeks

    Distance walked during a standard six-minute walk test.

Secondary outcomes

  1. dyspnea, fatigue, anxiety, depression, quality of life

    Time frame: Eight weeks

  2. Six minute walk distance

    Time frame: Six months after completion of pulmonary rehabilitation

  3. dyspnea, fatigue, anxiety, depression, quality of life

    Time frame: Six months after completion of pulmonary rehabilitation

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2010
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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