NCT02602834

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

October 6, 2015

Last Update Submit

November 9, 2016

Conditions

Heart Transplantation

Keywords

exercise testbiological markers

Outcome Measures

Primary Outcomes (4)

  • Changes in crp with interval training compared to moderate training

    1 week

  • Changes in interleukin levels with interval training compared to moderate training

    1 week

  • Changes in ICAM levels with interval training compared to moderate training

    1 week

  • Changes in MiRNA levels with interval training compared to moderate training

    1 week

Secondary Outcomes (3)

  • Questionnaire of quality of life

    baseline

  • Oxygen uptake

    baseline

  • Questionnaire of physical activity

    baseline

Study Arms (2)

HTx

EXPERIMENTAL

Heart transplant recipients n=15

Other: interval trainingOther: moderate exercise

Control

ACTIVE COMPARATOR

Healthy controls n=5

Other: interval trainingOther: moderate exercise

Interventions

interval trainingOTHER

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

ControlHTx
moderate exerciseOTHER

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

ControlHTx

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years after heart transplantation
  • Lives in Oslo or near Oslo
  • Stable health condition
  • Optimal medical treatment/ medication
  • No limiting physical handicap
  • Written consent
  • No verified heart disease
  • Willing to preform the study
  • Over 18 years
  • Written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OUS- Rikshospitalet

Oslo, Oslo County, 0424, Norway

Location

Related Publications (1)

  • 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.

    PMID: 29225901DERIVED

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lars LG Gullestad, professor

    OUS-Oslo university hospital rikshospitalet, cardiology department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD candidate

Study Record Dates

First Submitted

October 6, 2015

First Posted

November 11, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

NO(1)