Qigong Therapy For Heart Device Patients

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00027001
First received: November 15, 2001
Last updated: August 17, 2006
Last verified: July 2006

November 15, 2001
August 17, 2006
September 2000
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Complete list of historical versions of study NCT00027001 on ClinicalTrials.gov Archive Site
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Qigong Therapy For Heart Device Patients
Qigong Therapy for Heart Device Patients

The goal of this study is to improve the overall physical health and quality of life of patients attached to mechanical heart devices while awaiting heart transplantation. Qigong, an ancient Chinese exercise that involves active participation of the individual in the form of meditation, breathing exercises and simple physical movements, is used in combination with a structured exercise program. We are testing the hypotheses that Qigong, in combination with a structured exercise program that combines aerobic and resistance training will improve the cardiovascular health and improve the quality of life of patients on mechanical heart devices. To test these hypotheses, we are measuring cardiovascular function and quality of life parameters in patients attached to mechanical heart devices who have participated in the exercise program and have practiced Qigong, and comparing these measures to patients who participated in the exercise program, but did not practice Qigong. Information gained from this research will serve as a basis from which the application of exercise training and Qigong can be applied to the treatment of other chronic diseases in which the physical conditioning and/or quality of life of individuals is compromised.

The goal of this study is to improve the overall physical health and quality of life of patients attached to mechanical hearts or assist devices while awaiting heart transplantation. Qigong, an ancient Chinese exercise that involves active participation of the individual in the form of meditation, breathing exercises and simple physical movements, will be used as an adjunct to the therapies, including a structured exercise program, currently provided to these patients at the University of Arizona Health Sciences Center. Based on the results of studies that have demonstrated physiological and psychosocial benefits of structured exercise programs and the practice of qigong, the following hypotheses are proposed: 1) a structured exercise program that combines aerobic and resistance training will improve the cardiovascular health of patients on mechanical hearts and assist devices; these conditioning effects will be amplified by the practice of Qigong; 2) a structured exercise program that combines aerobic and resistance training will improve the quality of life of patients on mechanical hearts and assist devices; these conditioning effects will be amplified by the practice of Qigong; 3) improved quality of life and physical conditioning effected by the structured exercise program and Qigong will enhance quality of life and physical conditioning after cardiac transplantation. To test these hypotheses, the following specific aims will be accomplished: 1) obtain pilot data to evaluate alterations in specific measures of cardiovascular function and health in patients attached to mechanical heart or assist devices who have participated in a structured aerobic/resistance exercise program, with and without Qigong; 2) obtain pilot data to evaluate alterations in specific quality of life measures in patients attached to mechanical heart or assist devices who have participated in a structured aerobic/resistance exercise program, with and without Qigong; 3) as part of the clinical follow-up of these patients following heart transplantation, obtain pilot data to evaluate specific parameters of cardiovascular health and quality of life of individuals who were attached to mechanical heart or assist devices prior to receiving the transplant. Information gained from this research will serve as a basis from which the application of exercise training and Qigong can be applied to the treatment of other chronic disease states in which the physical conditioning and/or quality of life of individuals is compromised.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depressive Disorder
  • Cardiac Diseases
  • Behavioral: Aerobic and Resistance Exercises
  • Behavioral: Qigong
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2003
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The subjects of this study are patients who have been implanted with either a total artificial heart or ventricular assist device.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00027001
R21 AT000291-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP