Long Term Effect of High-intensity Training After Heart Transplantation

NCT ID: NCT02213770

Last Updated: 2016-01-25

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

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-11-30

Brief Summary

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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?

Detailed Description

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Conditions

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Heart Transplant Recipients

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Intervention group

Group that followed high- intensity interval training program in TEX study.

No interventions assigned to this group

Control group

Followed up on a regular basis for HTx recipients in Norway.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Cand med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Gullestad, professor

Role: STUDY_DIRECTOR

OUS- kardiologisk avdeling

Locations

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OUS- Rikshospitalet

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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Nytroen K, Myers J, Chan KN, Geiran OR, Gullestad L. Chronotropic responses to exercise in heart transplant recipients: 1-yr follow-up. Am J Phys Med Rehabil. 2011 Jul;90(7):579-88. doi: 10.1097/PHM.0b013e31821f711d.

Reference Type RESULT
PMID: 21765276 (View on PubMed)

Nytroen K, Rustad LA, Gude E, Hallen J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epub 2012 Jun 1.

Reference Type RESULT
PMID: 22659939 (View on PubMed)

Nytroen K, Rustad LA, Erikstad I, Aukrust P, Ueland T, Lekva T, Gude E, Wilhelmsen N, Hervold A, Aakhus S, Gullestad L, Arora S. Effect of high-intensity interval training on progression of cardiac allograft vasculopathy. J Heart Lung Transplant. 2013 Nov;32(11):1073-80. doi: 10.1016/j.healun.2013.06.023. Epub 2013 Jul 29.

Reference Type RESULT
PMID: 23906899 (View on PubMed)

Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.

Reference Type RESULT
PMID: 22900793 (View on PubMed)

Other Identifiers

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2014/872/REK sør-øst C

Identifier Type: -

Identifier Source: org_study_id

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