Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation

Heart Transplantation Clinical Trial

— Ergo-HTx  

Official title:

Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00752336
• Other study ID #: HTx-2777
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2008
• Last updated: September 12, 2008
• Start date: January 2002
• Est. completion date: September 2009

Study information

• Verified date: September 2008
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

Heart transplant (6-9 mts post Tx) stabile health condition at study entry (pt stays within home environment)

• Age = 18 yrs

• Sufficient language skills to answer questionnaire

• Follow-up at our center

• Willingness to participate by written informed consent

Exclusion Criteria:

• TVP diagnosis before study inclusion

• Episodes of recurrent acute rejections

• Medical contra-indication for regular exercise ergometer training

• Malignancy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Exercise Capacity
• Heart Transplantation

Intervention

Behavioral:
• exercise training; psychosocial support
supervised home-based endurance training; recommendation to exercise every other day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Roche Pharma AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRQoL,exercise capacity		36 mts	No
Secondary	Weight gain; cardiovascular risk factors; social re-integration		36 mts	No