Trial record 17 of 34 for:    cardiac rehabilitation | Open Studies | NIH, U.S. Fed

The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
George Mason University
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT02019641
First received: December 20, 2013
Last updated: March 21, 2014
Last verified: November 2013
  Purpose

We propose a randomized controlled trial (RCT) to determine the safety and efficacy of aerobic exercise for patients who have interstitial lung disease (ILD) uncomplicated by pulmonary hypertension. Aerobic exercise training (AET) based rehabilitation has become a standard of care for patients with pulmonary diseases such as COPD. In an uncontrolled study, we have observed more efficient cardiorespiratory function, increased physical work capacity, and improved health related quality of life (HRQoL), following AET, in patients who have ILD without pulmonary hypertension. We have also observed, in a RCT, similar findings in patients who have pulmonary hypertension complicated by ILD of various etiologies. Serious adverse events resulting from AET were not observed in these studies. Our work to date has established plausibility for the efficacy of AET and its safety for patients with ILD. A RCT is now needed to determine the efficacy of AET as a medically prescribed and supervised intervention in patients who have ILD. Our research team is uniquely qualified to undertake this research and is one of the few teams possessing the experience and background necessary for contributing to this novel, understudied, yet critical field of rehabilitation research.

Subjects will be over the age of 21 years and living within a reasonable travel distance from the greater Washington D.C. area. All tests will be conducted at the NIH Clinical Center and subjects will receive AET or a control regimen of patient education at the NIH Clinical Center. The staff are well experienced in providing exercise therapy for patients with ILD

There will be two primary treatment conditions. Patients with ILD will be randomized to either an intervention consisting of AET plus patient education (AET+) or a control condition that includes patient education only (CON). AET will consist of a 10-week regimen of supervised treadmill walking three times a week. The duration of the exercise sessions will progress from 30 minutes to 45 minutes per session over the 10 weeks as tolerated. The intensity of the exercise will be between 70 and 80% of the patient s heart rate reserve.

Those randomized to control will not engage in AET. There will, however, be a secondary study: a crossover design in which subjects in the CON group will subsequently complete the AET regimen.

The primary outcome measure for our trial will be 6-minute walk test distance (6MWD). Secondary outcome variables will include treadmill cardiorespiratory exercise test (tCPET) results with, pulmonary gas exchange, central circulatory function, and muscle oxygenation. A number of questionnaires will also be completed including: St. George s Respiratory Questionnaire, Fatigue Severity Scale, SF-36v2 Health Survey, Human Activity Profile, Profile of Mood States, and King s Brief Interstitial Lung Disease Health Status Questionnaire. All of this data will be obtained before and after the AET+ and CON regimens and in both of the secondary studies.

AET is generally safe, inexpensive, and can easily be made available and accessible to almost everyone. It requires no approval by regulatory agencies and is thus available as a medically prescribed and supervised intervention almost immediately following confirmation of its safety and efficacy. Six-minute walk distance is associated with improved HRQoL in patients with ILD and in specific subsets. Effective use of AET as a rehabilitative intervention could have a high degree of impact on these personal and public health outcomes in this advanced lung disease subset.


Condition Intervention Phase
Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Interstitial Pneumonitis
Desquamative Interstitial Pneumonia
Other: Aerobic Exercise Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 6MWT distance (most frequently used measured of physical performance for evaluating patients with ILD and other advanced lung diseases). MCID for 6MWT distance has been determined to be approximately 30 meters in ILD [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak work rate on the treadmill cardiopulmonary exercise test, and performance and perceived fatigability. We will also examine subject's acceptance onto transplant lists and patient mortality. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Aerobic Exercise Training
    N/A
Detailed Description:

We propose a rand

omized controlled trial (RCT) to determine the safety and efficacy of aerobic exercise for patients who have interstitial lung disease (ILD) uncomplicated by pulmonary hypertension. Aerobic exercise training (AET) based rehabilitation has become a standard of care for patients with pulmonary diseases such as COPD. In an uncontrolled study, we have observed more efficient cardiorespiratory function, increased physical work capacity, and improved health related quality of life (HRQoL), following AET, in patients who have ILD without pulmonary hypertension. We have also observed, in a RCT, similar findings in patients who have pulmonary hypertension complicated by ILD of various etiologies. Serious adverse events resulting from AET were not observed in these studies. Our work to date has established plausibility for the efficacy of AET and its safety for patients with ILD. A RCT is now needed to determine the efficacy of AET as a medically prescribed and supervised intervention in patients who have ILD. Our research team is uniquely qualified to undertake this research and is one of the few teams possessing the experience and background necessary for contributing to this novel, understudied, yet critical field of rehabilitation research.

Subjects will be over the age of 21 years and living within a reasonable travel distance from the greater Washington D.C. area. All tests will be conducted at the NIH Clinical Center and subjects will receive AET or a control regimen of patient education at the NIH Clinical Center. The staff are well experienced in providing exercise therapy for patients with ILD.

There will be two primary treatment conditions. Patients with ILD will be randomized to either an intervention consisting of AET plus patient education (AET+) or a control condition that includes patient education only (CON). AET will consist of a 10-week regimen of supervised treadmill walking three times a week. The duration of the exercise sessions will progress from 30 minutes to 45 minutes per session over the 10 weeks as tolerated. The intensity of the exercise will be between 70 and 80% of the patient s heart rate reserve. Those randomized to control will not engage in AET. There will, however, be a secondary study: a crossover design in which subjects in the CON group will subsequently complete the AET regimen.

The primary outcome measure for our trial will be 6-minute walk test distance (6MWD). Secondary outcome variables will include treadmill cardiorespiratory exercise test (tCPET) results with, pulmonary gas exchange, central circulatory function, and muscle oxygenation. A number of questionnaires will also be completed including: St. George s Respiratory Questionnaire, Fatigue Severity Scale, SF-36v2 Health Survey, Human Activity Profile, Profile of Mood States, and King s Brief Interstitial Lung Disease Health Status Questionnaire. All of this data will be obtained before and after the AET+ and CON regimens and in both of the secondary studies.

AET is generally safe, inexpensive, and can easily be made available and accessible to almost everyone. It requires no approval by regulatory agencies and is thus available as a medically prescribed and supervised intervention almost immediately following confirmation of its safety and efficacy. Six-minute walk distance is associated with improved HRQoL in patients with ILD and in specific subsets. Effective use of AET as a rehabilitative intervention could have a high degree of impact on these personal and public health outcomes in this advanced lung disease subset.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

ILD Groups: Subjects in this study will include individuals with ILD who are referred for Pulmonary Rehabilitation. The following list provides more specific inclusion criteria:

  • Between age 21-80 years
  • WHO functional class II or III, will accept WHO functional class I and IV based on 6 minute walk test results (less than or equal to 400 meters for Class I and greater than or equal to50 meters for Class IV)
  • No episodes of syncope or significant chest pain for at least one month.
  • No prior Pulmonary Rehabilitation received within the last 6 months and not currently in a maintenance program.
  • Physically inactive, no participation in a structured exercise program as defined as more than 30 minutes of exercise 3 or more days a week within the last 6 months.
  • Patients may qualify if they have any one of the following conditions:

    • Interstitial lung disease, including idiopathic pulmonary fibrosis (IPF), non-specific pulmonary fibrosis (NSIP), sarcoidosis or other form of chronic lung fibrosis based on clinical context via clinic note from primary pulmonologist and an echo prior to enrollment showing an RVSP < 40mmHg and/or estimated mean < 25 mmHg. < TAB>

      • If RVSP is unable to be estimated on the echo at NIH, the absence of the following abnormalities on echo will be used to rule out pulmonary hypertension: right ventricular enlargement, right ventricular hypertrophy, paradoxical movement of interventricular septum and/or altered pulmonary flow velocity. If RVSP is unable to be estimated and these abnormalities are absent on echo, the patient will be enrolled.

EXCLUSION CRITERIA:

Since the goal is to examine exercise responses and adaptations as affected by ILD, patients will have no other medical conditions that would impair aerobic capacity or the ability to engage in physical activity. These conditions would include any of those affecting the cardiovascular, pulmonary, metabolic, neurological, or musculoskeletal systems. Specific exclusion criteria are:

Inability to maintain a resting oxygen saturation greater than or equal to 90% SpO2, measured by pulse oximetry, on supplemental oxygen

  • Inability to complete a treadmill cardiopulmonary exercise test based on the specified criteria.
  • Diagnosis of ischemic heart disease
  • Left ventricular dysfunction with the ejection fraction < 50%
  • Acute cor pulmonale
  • Dilated or hypertrophic cardiomyopathy
  • Non-idiopathic cardiomyopathy
  • Significant hepatic or renal dysfunction
  • Metastatic cancer with a life expectancy of less than one year.
  • Disabling stroke
  • Active substance abuse

    -Severe psychiatric disease

  • Patients on antiretroviral therapy
  • Uncontrolled diabetes mellitus with a history of DKA
  • Mitochondrial disease
  • Pregnancy
  • Ongoing tobacco use
  • Acceptance onto a lung transplant waiting list
  • No participation in ongoing ILD drug trials prior to enrolling in this study and throughout the duration of their participation in this study. Patients may continue to take any currently prescribed medications throughout the entire protocol. However any changes to current medications or addition of other medications during the course of the study must be reported within one week to the PI or associate investigator.
  • General medical complications that pose a risk to exercise testing or training as determined by the PI (eg.. Severe peripheral vascular disease, Reynaud s Syndrome, etc)

Other Exclusions:

  • The age range of the subjects will be limited to those between 21 and 80 years because the normal adaptive processes to aerobic exercise are generally less well understood in the childhood, adolescent, and aged subset of the population, and reference ranges for many of the exercise response variables are less well accepted than in the general adult subset.
  • Subjects will not typically include individuals in Class I because patients are usually in Class II or III at the time of diagnosis.
  • Subjects in NYHA Class IV will typically be excluded as the instability of their symptoms is a contraindication for exercise testing or training by nearly all published guidelines.
  • Subjects in Class I may be included if they are able to walk less than 400 meters.
  • Subjects in Class IV may be included if they are able to walk at least 50 meters.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019641

Contacts
Contact: Anne B Quinn, R.N. (301) 443-9083 quinna@cc.nih.gov
Contact: Leighton Chan, M.D. (301) 496-4733 chanle@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
George Mason University
Investigators
Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02019641     History of Changes
Other Study ID Numbers: 140027, 14-CC-0027
Study First Received: December 20, 2013
Last Updated: March 21, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Exercise
Interstitial Lung Disease
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pneumonia
Pulmonary Fibrosis
Lung Diseases, Interstitial
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Idiopathic Interstitial Pneumonias

ClinicalTrials.gov processed this record on July 29, 2014