High-Intensity Training Following Lung Transplantation

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Transplant, Exercise Training

Intervention / Treatment
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* Behavioral: High-intensity training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Intensity Training<br> | Behavioral: High-intensity training<br>* 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.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak oxygen uptake | Measured by cardiopulmonary exercise test | 0-20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total body composition (fat, muscle and bone mass) | Measured by dual-energy x-ray absorptiometry (DEXA) | 0-20 weeks | 
| Change in forced expiratory volume in one second (FEV1) | Measured by spirometry | 0-20 weeks | 
| Change submaximal exercise capacity | Measured by 6-minute walk distance | 0-20 weeks | 
| Change in leg strength | Measured by maximum leg press | 0-20 weeks | 
| Change in upper body strength | Measured by maximum breast press | 0-20 weeks | 
| Change in hand strength | Measured by grip strength dynamometer | 0-20 weeks | 
| Change in health-related quality of life | Measured by Short Form 36 (SF-36) | 0-20 weeks |