Long Term Effect of High-intensity Training After Heart Transplantation

Heart Transplant Recipients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213770
• Other study ID #: 2014/872/REK sør-øst C
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: January 22, 2016
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Transplant Recipients

Locations

Country	Name	City	State
Norway	OUS- Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Health Association

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Nytrøen 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. — View Citation

Nytrøen K, Rustad LA, Aukrust P, Ueland T, Hallén 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 Tran — View Citation

Nytrøen 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 — View Citation

Nytrøen K, Rustad LA, Gude E, Hallén 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean VO2peak in the intervention group and control group	We will use the same test protocol as the TEX- study.	5 years after start of inclusion in RCT (TEX). One measurment.	No
Secondary	How many has progression of cardiac allograft vasculopathy in the intervention group and control group.	Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX.	5 years after inclusion in RCT (TEX study).	No
Secondary	Mean muscle capacity in the intervention group and control group.		5 years after inclusion in RCT, TEX study.	No
Secondary	Quality of life	We will use validated questionnaires to estimate quality of life and to evaluate depression.	5 years after inclusion in TEX- study.	No
Secondary	Difference in activity level between groups	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.	No