Effect of Exercise After Heart Transplantation (TEX)

University of Oslo (UIO)

Status and phase: Completed; Phase 2

Conditions: Heart Transplantation

Treatments: Other: Interval-based aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01091194

10920

Details and patient eligibility

About

This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Norwegian heart transplanted patients > 18 years of age
• 1-8 years after heart transplantation
• Optimal medical treatment
• Stable condition
• Written informed consent
• Must have access to a physical therapist or personal trainer in their hometown
• Motivation for exercise

Exclusion criteria

• Unstable condition
• In need of revascularization or other invention
• Infections, open wounds or skin diseases
• Physical disabilities which prevent participation
• Other diseases, illnesses or conditions which contradict exercise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Exercise

Other group

Description:

Interval-based aerobic exercise

Treatment:

Other: Interval-based aerobic exercise

Control

No Intervention group

Description:

No intervention other than regular follow up hospital visits