- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00027001
Qigong Therapy For Heart Device Patients
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- University of Arizona Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
The subjects of this study are patients who have been implanted with either a total artificial heart or ventricular assist device.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2000
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
November 15, 2001
First Submitted That Met QC Criteria
November 15, 2001
First Posted (Estimate)
November 16, 2001
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT000291-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depressive Disorder
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Samsung Medical CenterUnknownMajor Depressive Disorder, Anxiety DisorderKorea, Republic of
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedDepressive Disorder, Major Depressive DisorderUnited States
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
Clinical Trials on Aerobic and Resistance Exercises
-
Cairo UniversityActive, not recruiting
-
Riphah International UniversityCompleted
-
Qassim UniversityCompleted
-
Riphah International UniversityCompletedPolycystic Ovary SyndromePakistan
-
University of HailCompleted
-
Riphah International UniversityRecruitingComparison of Aerobic Exercise and Resistance TrainingPakistan
-
Egyptian Chinese UniversityActive, not recruiting
-
Riphah International UniversityCompletedComparison of (Balance, Resistance, Aerobic and Cognitive Exercises) & (Balance Resistance Exercise)Elderly PopulationPakistan
-
Louis BhererCanadian Institutes of Health Research (CIHR); The Montreal Health Innovations...RecruitingAging | Cardiovascular Risk FactorCanada
-
Istanbul Medeniyet UniversityRecruiting