Lung TransplantHILTNCT03155074
High-Intensity Training Following Lung Transplantation
A study testing High-intensity training in people with Lung Transplant and Exercise Training, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant, Exercise Training
- What is being tested?
- High-intensity training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNorway
- Study dates
- 22 Aug 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable medical condition in the opinion of the enrolling investigator
- Able and willing to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Transplant, Exercise Training
- Being tested
- High-intensity training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Training | Experimental | Not described Receives: Behavioral: High-intensity training |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake
Measured by cardiopulmonary exercise test
Measured: 0-20 weeks
Secondary outcomes (7)
Change in total body composition (fat, muscle and bone mass)
Measured by dual-energy x-ray absorptiometry (DEXA)
Measured: 0-20 weeks
Change in forced expiratory volume in one second (FEV1)
Measured by spirometry
Measured: 0-20 weeks
Change submaximal exercise capacity
Measured by 6-minute walk distance
Measured: 0-20 weeks
Change in leg strength
Measured by maximum leg press
Measured: 0-20 weeks
Change in upper body strength
Measured by maximum breast press
Measured: 0-20 weeks
Change in hand strength
Measured by grip strength dynamometer
Measured: 0-20 weeks
Change in health-related quality of life
Measured by Short Form 36 (SF-36)
Measured: 0-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start22 Aug 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Michael Durheim, Oslo University Hospital
- Investigators
- Elisabeth Edvardsen, PhD, Principal investigator, Oslo University Hospital, Norwegian School of Sport SciencesMichael T Durheim, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155074
- Sponsor's protocol ID
- 2017/399
- Acronym
- HILT
- Status last verified
- Nov 2023
- First submitted
- 10 May 2017
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34282853
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Training Following Lung Transplantation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03155074
- Acronym / sponsor ID
- HILT / 2017/399
- Conditions
- Lung Transplant, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Training | Experimental | Behavioral: High-intensity training |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable medical condition in the opinion of the enrolling investigator
- Able and willing to give informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity trainingThe 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. | Behavioural | High-Intensity Training |
Primary outcome
Change in peak oxygen uptake
Time frame: 0-20 weeks
Measured by cardiopulmonary exercise test
7 secondary outcomes
Change in total body composition (fat, muscle and bone mass)
Time frame: 0-20 weeks
Change in forced expiratory volume in one second (FEV1)
Time frame: 0-20 weeks
Change submaximal exercise capacity
Time frame: 0-20 weeks
Change in leg strength
Time frame: 0-20 weeks
Change in upper body strength
Time frame: 0-20 weeks
Change in hand strength
Time frame: 0-20 weeks
Change in health-related quality of life
Time frame: 0-20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 34282853Gutierrez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Edvardsen, PhD principal investigator
Oslo University Hospital, Norwegian School of Sport Sciences
Michael T Durheim, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity training in people with Lung Transplant and Exercise Training, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (time frame: 0-20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.