NCT01914406

Brief Summary

The aim of this study was to examine the effects of high intensity aerobic interval training (AIT) versus moderate continuous training (CON) in heart transplant recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration 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

January 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

2.8 years

First QC Date

July 25, 2013

Last Update Submit

October 23, 2023

Conditions

Heart Transplant Recipients

Keywords

Heart transplant recipientsExercise capacityendothelial functionQuality of life

Outcome Measures

Primary Outcomes (1)

  • VO2peak

    baseline test before randomization 1. follow-up after 12 weeks of exercise 2. follow-up after 5 month washout. 3. follow-up after second 12 weeks period of exercise.

    baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

Secondary Outcomes (5)

  • Endothelial function (endoPAT)

    baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

  • Quality of Life (QoL)SF-36

    baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

  • HADS-a, HADS-d anxiety and depression

    baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

  • Bloodsamples/biomarkers.

    baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

  • augmentation index (AI), endoPAT

    baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

Study Arms (2)

high intense interval training

OTHER

Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.

Other: high intense interval training

continuous moderate training

ACTIVE COMPARATOR

Continued exercise 45 min.

Other: continuous moderate training

Interventions

high intense interval trainingOTHER

Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.

high intense interval training
continuous moderate trainingOTHER

Continued exercise 45 min.

continuous moderate training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable Heart transplant recipients \> 12 month or more after HTx, age \> 18 years,\< 80. willing and capable of giving written informed consent for study participation.

You may not qualify if:

  • unstable condition postoperative complications, recent severe rejection episodes (\>H1R \< 3 month), re-transplantation or multi-organtransplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Rehabilitation, Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

Study Officials

  • Christian H Dall, cand.scient

    Bispebjerg Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 25, 2013

First Posted

August 2, 2013

Study Start

January 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

DK(1)