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High-Intensity Training Following Lung Transplantation (HILT)

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ClinicalTrials.gov Identifier: NCT03155074
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
Norwegian School of Sport Sciences
Information provided by (Responsible Party):
Michael Durheim, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Lung Transplant Exercise Training Behavioral: High-intensity training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High-Intensity Training Following Lung Transplantation: a Randomized Controlled Trial
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

No Intervention: Usual Care



Primary Outcome Measures :
  1. Change in peak oxygen uptake [ Time Frame: 0-20 weeks ]
    Measured by cardiopulmonary exercise test


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155074


Contacts
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Contact: Michael T Durheim, MD (+47) 23 07 06 71 micdur@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Mariann Ulvestad         
Sponsors and Collaborators
Oslo University Hospital
Norwegian School of Sport Sciences
Investigators
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Principal Investigator: Elisabeth Edvardsen, PhD Oslo University Hospital, Norwegian School of Sport Sciences
Principal Investigator: Michael T Durheim, MD Oslo University Hospital

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Responsible Party: Michael Durheim, Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03155074     History of Changes
Other Study ID Numbers: 2017/399
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No