NCT00027001

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2000

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

November 15, 2001

Last Update Submit

August 17, 2006

Conditions

Depressive DisorderCardiac Diseases

Keywords

Qigong, exercise, circulatory assist devices

Interventions

Aerobic and Resistance ExercisesBEHAVIORAL
QigongBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
The subjects of this study are patients who have been implanted with either a total artificial heart or ventricular assist device.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Health Sciences Center

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Depressive DisorderHeart DiseasesMotor Activity

Interventions

Qigong

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 15, 2001

First Posted

November 16, 2001

Study Start

September 1, 2000

Study Completion

June 1, 2003

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations

US(1)