Step Trial of Exercise and Self-management in Severe Cardiopulmonary Illness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00467298
First received: April 25, 2007
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Heart Failure
Behavioral: Exercise adherence
Behavioral: Self-management- prevention of illness
Behavioral: Self-management of illness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Intervention to Enhance Function in Severe Cardiopulmonary Illness

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Improvement in function capability [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in functional capability, quality of life, self-efficacy, cardiopulmonary function, gait & balance; mediating effects of self-regulation model on functional capability, etc.; reduction in hospital admissions, outpatient visits & expenditures. [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Novel intensive self-management education and exercise program of four weeks
Behavioral: Exercise adherence
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.
Behavioral: Self-management- prevention of illness
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.
Behavioral: Self-management of illness
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.
No Intervention: Arm 2
Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration

Detailed Description:

This study is a randomized, controlled trial of a cardiopulmonary exercise and self-management intervention to improve functional capacity, health related-related quality of life, and to reduce health care costs in medically fragile, elderly patients with chronic obstructive pulmonary disease (COPD) or heart failure (HF). Specific aims include: (1) To determine the benefits of a combined outpatient/home-based exercise, self-management program on function al capability (daily activity, six-minute qalk distance, symptoms), (2) to determine the effects of exercise/self-management on quality of life, health status, cardiopulmonary function, and gait and balance, (3) to test the theoretical self-regulation model for mediating effects on major outcome variables, and (4) to compare health care resource utilization and expenditures between the intervention and usual care groups in order to conduct a cost-effectiveness analysis of the program. The primary outcome upon which the study is powered is functional capability measured by daily physical activity. Outcomes will be measured at three time points: at entry and following the intervention at 6 and 12 months. Two-hundred (100/group) will be recruited from the VA Puget Sound Health Care System outpatient clinics. The study will be carried out over four years. Inclusion criteria include 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 outpatient visits for same over the past year. Exclusion criteria include 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 and life expectancy less than one year. The intervention consists of a month long program of two 2-hour visits a week incorporating equal time for endurance and strength training as well as individually-tailored instruction in self-management of their heart/lung disease. Usual care control is an 8-week standard cardiopulmonary exercise program, two days a week for an hour with some self-management content.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT00467298

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Investigators
Principal Investigator: 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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00467298     History of Changes
Other Study ID Numbers: NRI 04-242
Study First Received: April 25, 2007
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Exercise
heart failure
chronic obstructive pulmonary disease
patient education
costs
quality of life

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014