Heart Transplant Recipients
Conditions
Keywords
Heart transplant recipients, Exercise capacity, endothelial function, Quality of life
Brief summary
The aim of this study was to examine the effects of high intensity aerobic interval training (AIT) versus moderate continuous training (CON) in heart transplant recipients.
Detailed description
Clinically stable heart transplant recipients \> 12 month or more after HTx, age \> 18 years, willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months were included from the Heart Centre, Rigshospitalet, Copenhagen University Hospital. Patients were excluded due to unstable condition or postoperative complications, recent severe rejection episodes (\>H1R \< 3 month), physical disabilities which prevent participation and re-transplantation or multi-organtransplantation.
Interventions
Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.
OTHERcontinuous moderate training
Continued exercise 45 min.
Sponsors
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-stable Heart transplant recipients \> 12 month or more after HTx, age \> 18 years,\< 80. willing and capable of giving written informed consent for study participation.
Exclusion criteria
unstable condition postoperative complications, recent severe rejection episodes (\>H1R \< 3 month), re-transplantation or multi-organtransplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2peak | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | baseline test before randomization 1. follow-up after 12 weeks of exercise 2. follow-up after 5 month washout. 3. follow-up after second 12 weeks period of exercise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bloodsamples/biomarkers. | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | Samples cooled on ice, centrifuged for 10 minutes and the plasma transferred to microtubes and stored at -80°C. Biomarkers analysed at department of biomedicine at University of Copenhagen. |
| augmentation index (AI), endoPAT | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | Augmentation index (AI)derived from pulse wave analyses and is a measure of arterial stiffness, (EndoPAT). |
| Endothelial function (endoPAT) | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | After the release of the cuff the hyperemic response was recorded and the reactive hyperemia index (RHI) was calculated automatic independent of operator. (endoPAT) |
| Quality of Life (QoL)SF-36 | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | SF-36, information on Quality of Life |
| HADS-a, HADS-d anxiety and depression | baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month). | Symptoms of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS). |
Countries
Denmark
Outcome results
None listed