Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation

NCT ID: NCT02602834

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-11-30

Brief Summary

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High intensity Interval training (HIT) has repeatedly been documented to have superior positive effects on oxygen uptake and general physical health compared to continuous moderate exercise in healthy individuals and patients with heart disease. Recently, the same effect has been shown in heart transplanted recipients. Which mechanisms that explains this difference is uncertain; the effect can be due to changes in the heart or changes in the peripheral tissue and muscles. To explore these mechanisms the investigators will in this study compare two different exercise modalities, and explore how different biomarkers change in blood, related to exercise.

Detailed Description

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15 heart transplanted recipients (and 5 healthy controls) will be included in the study. Each patient will have three study-days.

The study is designed to be a cross-over study. And randomisation will decide which training they will have som training session 1 and training session 2; Interval or continuous training.

Before starting the two training sessions they will measure oxygen uptake and baseline blood samples.

During each exercise session the patients will take blood samples during and after exercise.

After first study admission the patients will have a wash out period for 1 week until first training session, and another week until the last session.

Conditions

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Heart Transplantation

Keywords

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exercise test biological markers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HTx

Heart transplant recipients n=15

Group Type EXPERIMENTAL

interval training

Intervention Type OTHER

4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.

moderate exercise

Intervention Type OTHER

30 minutes (moderate intensity) aerobic exercise on treadmill without rest.

Control

Healthy controls n=5

Group Type ACTIVE_COMPARATOR

interval training

Intervention Type OTHER

4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.

moderate exercise

Intervention Type OTHER

30 minutes (moderate intensity) aerobic exercise on treadmill without rest.

Interventions

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interval training

4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.

Intervention Type OTHER

moderate exercise

30 minutes (moderate intensity) aerobic exercise on treadmill without rest.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1-10 years after heart transplantation
* Lives in Oslo or near Oslo
* Stable health condition
* Optimal medical treatment/ medication
* No limiting physical handicap
* Written consent

Inclusion healthy control:

* No verified heart disease
* Willing to preform the study
* Over 18 years
* Written consent

Exclusion Criteria

* Under 1 year or over 10 year since HTx.
* Lives far from Oslo
* Unstable health condition
* Not optimal medical treatment and/ or medication
* Limiting physical handicap
* Under 18 years
* Not written consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian Health Association

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Yardley

MD, PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars LG Gullestad, professor

Role: STUDY_DIRECTOR

OUS-Oslo university hospital rikshospitalet, cardiology department

Locations

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OUS- Rikshospitalet

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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Yardley M, Ueland T, Aukrust P, Michelsen A, Bjorkelund E, Gullestad L, Nytroen K. Immediate response in markers of inflammation and angiogenesis during exercise: a randomised cross-over study in heart transplant recipients. Open Heart. 2017 Nov 28;4(2):e000635. doi: 10.1136/openhrt-2017-000635. eCollection 2017.

Reference Type DERIVED
PMID: 29225901 (View on PubMed)

Other Identifiers

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2015/97/REK sør-øst A

Identifier Type: -

Identifier Source: org_study_id