An Intervention to Improve Function in Severe Cardiopulmonary Illness

NCT00467298 | Completed Results DMC

• 1 other identifier: NRI 04-242
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized trial of a cardiopulmonary self-management intervention to improve functional capacity, health-related quality of life, and to reduce health care utilization. Two hundred (100 in each group) will be recruited from VA Puget Sound Health Care System over four years. Outcomes will be measured at three points: at entry, at the end of the 6 month intervention, and 12 months after entry. Change in functional capacity at the end of the intervention program is the primary outcome.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Heart Failure

Keywords

Exercise; heart failure; chronic obstructive pulmonary disease; patient education; costs; quality of life

Outcome Measures

Primary Outcomes (1)

• Function Capability

  6MWT-Six Minute Walk Test

  6 months

Secondary Outcomes (1)

• Quality of Life

  6 months

Study Arms (2)

Self-management

EXPERIMENTAL

Novel intensive self-management education and exercise program of four weeks

Behavioral: Exercise adherence; Behavioral: Self-management- prevention of illness; Behavioral: Self-management of illness

Usual care

NO INTERVENTION

Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration

Interventions

Exercise adherence BEHAVIORAL

The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.

Self-management

Self-management- prevention of illness BEHAVIORAL

Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.

Self-management

Self-management of illness BEHAVIORAL

This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.

Self-management

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• standard criteria for severe COPD or HF,
• optimal medical management,
• willingness to participate in an outpatient exercise/self-management program,
• working phone,
• hospitalization for HF, COPD, or related illness in the past two years or at least two unscheduled outpatient visits for same over the past year

You may not qualify if:

• unstable disease or recent surgery,
• supplemental oxygen requirement at rest more than 4 LPM,
• already participating in regular exercise three times a week,
• inability to ambulate,
• uncontrolled mental illness,
• alcohol or drug abuse,
• life expectancy less than one year

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98101, United States

Location

Related Publications (6)

• Steele BG, Belza B, Cain KC, Coppersmith J, Lakshminarayan S, Howard J, Haselkorn JK. A randomized clinical trial of an activity and exercise adherence intervention in chronic pulmonary disease. Arch Phys Med Rehabil. 2008 Mar;89(3):404-12. doi: 10.1016/j.apmr.2007.11.003.

  PMID: 18295615 BACKGROUND

• Steele BG, Cain K, Coppersmith J, Belza B, Howard J, Lakshminarayan S. Pulmonary rehabilitation (PR) outcomes in chronic obstructive pulmonary disease (COPD): Are benefits equivalent in end-stage disease? Proceedings of the American Thoracic Society. 2008 May 17; 177:A446.

  BACKGROUND

• Steele BG, Belza B, Cain K, Coppersmith J, Howard J, Lakshminarayan S, Haselkorn J. The impact of chronic obstructive pulmonary disease exacerbation on pulmonary rehabilitation participation and functional outcomes. J Cardiopulm Rehabil Prev. 2010 Jan-Feb;30(1):53-60. doi: 10.1097/HCR.0b013e3181c85845.

  PMID: 20068424 BACKGROUND

• Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. doi: 10.2147/copd.s6643. Epub 2009 Sep 1.

  PMID: 19750190 RESULT

• Dougherty CM, Steele BG, Hunziker J. Testing an intervention to improve functional capability in advanced cardiopulmonary illness. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):35-41. doi: 10.1097/HCR.0b013e3181f1fd77.

  PMID: 20861749 RESULT

• Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.

  PMID: 22772084 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Cynthia M. Dougherty
• Organization: VA Puget Sound Health Care System-Seattle

cynthia.dougherty@va.gov

206 764 2205

Study Officials

• Bonnie G. Steele, PhD RN

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

• Cynthia M. Dougherty, PhD RN

  VA Puget Sound Health Care System, Seattle

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 30, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 2, 2018
• Results First Posted: April 2, 2018

Record last verified: 2017-08

Locations

US (1)