NCT03329586

Brief Summary

The investigators will investigate whether high-intensity exercise training can safely improve physical performance in long-term stable heart, kidney, lung, and liver transplant recipients. Adult transplant recipients will participate in Transplantoux, a 6-month individualized home- and group-based training program, with the goal to cycle the Mont Ventoux in France. The investigators will do cardiopulmonary exercise testing : maximal oxygen consumption, maximal power and BMI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

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

August 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2014

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 7, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

October 30, 2017

Last Update Submit

November 6, 2017

Conditions

Physical Activity After Organ Transplantation

Keywords

maximum oxygen consumptionorgan transplantationphysical fitnessrehabilitation

Outcome Measures

Primary Outcomes (1)

  • VO2max

    Maximal oxygen consumption

    6 months after start training

Study Arms (1)

Training

EXPERIMENTAL
Other: High-intensity training

Interventions

High-intensity trainingOTHER

6-month individualized home- and group-based training program with the goal to cycle the Mont Ventoux in France

Training

Eligibility Criteria

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

You may qualify if:

  • minimum post-transplant period of 6 months
  • no acute rejection during the immediately preceding 6 months

You may not qualify if:

  • patients with cardiovascular or orthopedic contra-indications for intensive physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

August 1, 2013

Primary Completion

June 21, 2014

Study Completion

July 31, 2014

Last Updated

November 7, 2017

Record last verified: 2017-10

Locations

BE(1)