High-Intensity Training Following Lung Transplantation

Exercise Training Clinical Trial

— HILT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155074
• Other study ID #: 2017/399
• Status: Completed
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exercise Training
• Lung Transplant

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian School of Sport Sciences

Country where clinical trial is conducted

Norway, 

Outcome

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