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Long Term Effect of High-intensity Training After Heart Transplantation

22. januar 2016 opdateret af: Marianne Yardley, Oslo University Hospital

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:

Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study period continue during long term follow up (5 years)?
Is the intervention group more physical active after HIT compared to the control group?

Studieoversigt

Status

Afsluttet

Betingelser

Hjertetransplantationsmodtagere

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Norge
- - Oslo, Norge, 0424
    - OUS- Rikshospitalet

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The TEX population.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
Intervention group Group that followed high- intensity interval training program in TEX study.
Control group Followed up on a regular basis for HTx recipients in Norway.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
mean VO2peak in the intervention group and control group Tidsramme: 5 years after start of inclusion in RCT (TEX). One measurment.	We will use the same test protocol as the TEX- study.	5 years after start of inclusion in RCT (TEX). One measurment.

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
How many has progression of cardiac allograft vasculopathy in the intervention group and control group. Tidsramme: 5 years after inclusion in RCT (TEX study).	Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX.	5 years after inclusion in RCT (TEX study).
Mean muscle capacity in the intervention group and control group. Tidsramme: 5 years after inclusion in RCT, TEX study.		5 years after inclusion in RCT, TEX study.
Quality of life Tidsramme: 5 years after inclusion in TEX- study.	We will use validated questionnaires to estimate quality of life and to evaluate depression.	5 years after inclusion in TEX- study.
Difference in activity level between groups Tidsramme: 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.	5 years after inclusion i RCT, TEX study.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Oslo University Hospital

Samarbejdspartnere

Norwegian Health Association

Efterforskere

Studieleder: Lars Gullestad, professor, OUS- kardiologisk avdeling

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2014

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)