High-Intensity Training Following Lung Transplantation (HILT)

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

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.

Study Overview

• Status: Completed
• Conditions: Exercise Training; Lung Transplant
• Intervention / Treatment: Behavioral: High-intensity training

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: High-Intensity Training	Behavioral: High-intensity training; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Norwegian School of Sport Sciences
• Investigators: Principal Investigator: Elisabeth Edvardsen, PhD, Oslo University Hospital, Norwegian School of Sport Sciences; Principal Investigator: Michael T Durheim, MD, Oslo University Hospital

Publications and helpful links

General Publications

• Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2017/399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No