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

Heart Transplantation Clinical Trial

Official title:

Changes in Blood Measured Before, During and After Exercise in Heart Transplant Recipients. Imminently Effect of Interval Training With High Intensity Compared With Continuous Moderate Intensity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602834
• Other study ID #: 2015/97/REK sør-øst A
• Status: Completed
• Phase: N/A
• First received: October 6, 2015
• Last updated: November 9, 2016
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (HTx):

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Other:
• interval training
4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.
• moderate exercise
30 minutes (moderate intensity) aerobic exercise on treadmill without rest.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in crp with interval training compared to moderate training		1 week	No
Primary	Changes in interleukin levels with interval training compared to moderate training		1 week	No
Primary	Changes in ICAM levels with interval training compared to moderate training		1 week	No
Primary	Changes in MiRNA levels with interval training compared to moderate training		1 week	No
Secondary	Questionnaire of quality of life		baseline	No
Secondary	Oxygen uptake	V02 peak measured på exercise test on treadmill.	baseline	No
Secondary	Questionnaire of physical activity		baseline	No