High-Intensity Training Following Lung Transplantation

NCT03155074 | Completed

• 1 other identifier: 2017/399
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Transplant; Exercise Training

Outcome Measures

Primary Outcomes (1)

• Change in peak oxygen uptake

  Measured by cardiopulmonary exercise test

  0-20 weeks

Secondary Outcomes (7)

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

  0-20 weeks

• Change in forced expiratory volume in one second (FEV1)

  0-20 weeks

• Change submaximal exercise capacity

  0-20 weeks

• Change in leg strength

  0-20 weeks

• Change in upper body strength

  0-20 weeks

Study Arms (2)

High-Intensity Training

EXPERIMENTAL

Behavioral: High-intensity training

Usual Care

NO INTERVENTION

Interventions

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.

High-Intensity Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian School of Sport Sciences: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 34282853 DERIVED

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elisabeth Edvardsen, PhD

  Oslo University Hospital, Norwegian School of Sport Sciences

  PRINCIPAL INVESTIGATOR

• Michael T Durheim, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 16, 2017
• Study Start: August 22, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)