Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00027001
Other study ID # R21AT000291-01
Secondary ID
Status Completed
Phase N/A
First received November 15, 2001
Last updated August 17, 2006
Start date September 2000
Est. completion date June 2003

Study information

Verified date July 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility The subjects of this study are patients who have been implanted with either a total artificial heart or ventricular assist device.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Aerobic and Resistance Exercises

Qigong


Locations

Country Name City State
United States University of Arizona Health Sciences Center Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT01316926 - Paxil CR Bioequivalence Study Brazil Phase 1
Recruiting NCT06187454 - Transcranial Direct Current Stimulation for Depression N/A
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT05768126 - Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine Phase 4
Completed NCT03219879 - Telephone-administered Relapse Prevention for Depression N/A
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Completed NCT03043560 - Study to Treat Major Depressive Disorder With a New Medication Phase 2
Completed NCT04091139 - Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong Phase 2/Phase 3
Completed NCT00069459 - Seasonal Affective Depression (SAD) Study Phase 1
Recruiting NCT05503966 - Combining Antidepressants and Attention Bias Modification in Depression N/A
Recruiting NCT03001245 - Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents N/A
Completed NCT02939560 - TMS for Adults With Autism and Depression N/A
Completed NCT02542891 - European Comparative Effectiveness Research on Internet-based Depression Treatment N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Completed NCT02224508 - Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks N/A
Completed NCT02306551 - Well Being And Resilience: Mechanisms of Transmission of Health and Risk
Withdrawn NCT02238730 - Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01597661 - Bupropion & Cardio Birth Defect (Slone) N/A
Completed NCT01093053 - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations N/A