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Completed

NCT Number: NCT03155074

High-Intensity Training Following Lung Transplantation

The HILT study is a prospective, single-blinded, randomized controlled trial comparing a high-intensity exercise training intervention with usual care among adult lung transplant recipients. Patients randomized to the training intervention arm will undergo individually tailored high-intensity exercise training (80-95% of maximum heart rate) three hours per week for 20 weeks. Training will be conducted at local fitness centers on a one-on-one basis.

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Key information

Conditions

Lung Transplant Exercise Training

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable medical condition in the opinion of the enrolling investigator
  • Able and willing to give informed consent

Exclusion criteria

  • Expected survival less than 12 months
  • Unable to complete a maximal exercise test on a treadmill until exhaustion
  • Language barrier that interferes with data collection

Treatment and study plan

High-intensity training

Behavioral

The exercise program will include a cardiovascular warm-up, high intensity interval training and progressive resistance training (PRT). The intervention will focus on high-intensity training, mainly by uphill walking on a treadmill at 80-95 % of the maximal heart rate and PRT in three series at 6-12 RM by leg press, chest press, back extension, seat row, and front raises. During the first four weeks, the patients will be introduced to the program while focusing on safety, techniques and familiarization. The endurance intensity and strength load will then continuously increase based on the patients' improvement, tolerance of dyspnea, and feelings of well-being or fatigue on each exercise day.

Primary outcomes

  1. Change in peak oxygen uptake

    Time frame: 0-20 weeks

    Measured by cardiopulmonary exercise test

Secondary outcomes

  1. Change in total body composition (fat, muscle and bone mass)

    Time frame: 0-20 weeks

    Measured by dual-energy x-ray absorptiometry (DEXA)

  2. Change in forced expiratory volume in one second (FEV1)

    Time frame: 0-20 weeks

    Measured by spirometry

  3. Change submaximal exercise capacity

    Time frame: 0-20 weeks

    Measured by 6-minute walk distance

  4. Change in leg strength

    Time frame: 0-20 weeks

    Measured by maximum leg press

  5. Change in upper body strength

    Time frame: 0-20 weeks

    Measured by maximum breast press

  6. Change in hand strength

    Time frame: 0-20 weeks

    Measured by grip strength dynamometer

  7. Change in health-related quality of life

    Time frame: 0-20 weeks

    Measured by Short Form 36 (SF-36)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian School of Sport Sciences

Registry information

Official study title

High-Intensity Training Following Lung Transplantation: a Randomized Controlled Trial

Acronym: HILT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 16, 2017
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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