Long Term Effect of High-intensity Training After Heart Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02213770

Enrollment

Registered

2014-08-11

Start date

2014-08-31

Completion date

2015-11-30

Last updated

2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant Recipients

Brief summary

High-intensity training (HIT) has repeatedly been documented to have superior positive effects compared to moderate exercise in patients with coronary heart disease and heart failure. Since heart transplant recipients (HTx), have a denervated heart with different respond to exercise, HIT has previously not been introduced among these patients. Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found that this form of exercise also was highly effective and safe in long term HTx with clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we ask the following questions in this follow-up study: 1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study period continue during long term follow up (5 years)? 2. Is the intervention group more physical active after HIT compared to the control group?

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* stable situation * optimal medical treatment * written concent

Exclusion criteria

* unstable situation, * infections (open wounds or skin diseases), * physical conditions that prevents participation, * or other injuries/ diseases who are contraindicated with training.

Design outcomes

Primary

Measure	Time frame	Description
mean VO2peak in the intervention group and control group	5 years after start of inclusion in RCT (TEX). One measurment.	We will use the same test protocol as the TEX- study.

Secondary

Measure	Time frame	Description
How many has progression of cardiac allograft vasculopathy in the intervention group and control group.	5 years after inclusion in RCT (TEX study).	Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX.
Mean muscle capacity in the intervention group and control group.	5 years after inclusion in RCT, TEX study.	—
Quality of life	5 years after inclusion in TEX- study.	We will use validated questionnaires to estimate quality of life and to evaluate depression.
Difference in activity level between groups	5 years after inclusion i RCT, TEX study.	To estimate activity the study population will fill out a validated questionnaire about physical activity, and they will wear a physical activity monitor at home for one week.

Countries

Norway

Outcome results