Lung TransplantationNCT04244305
Endurance Training in Patients Undergoing Lung Transplantation
A study testing Exercise Therapy in people with Lung Transplantation, run by University Hospital A Coruña.
Trial summary
Lung Transplantation is usually the last option for patients with chronic respiratory conditions in the late stages of the disease. Pulmonary rehabilitation and, particularly, endurance training, is a cornerstone in the management of these patients both during the pre-operative as well as the post-operative period as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 May 2020
- 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
- Patients undergoing lung transplantation at the Thoracic Surgery Unit of the Hospital Clínico Universitario de A Coruña.
- Adults > 18 years.
- Ability to attend post-surgery exercise training for a minimum period of one month.
- Sign informed consent.
Who cannot join
- Torpid post-operative recovery with a prolonged stay at the Post-Anaesthesia Care Unit > 12 days.
- Diagnosed with intensive care unit acquired muscle weakness.
About this study
Official title: Endurance Training in Patients Undergoing Lung Transplantation: Differences Between Treadmill and Cycle Ergometry Training
Lung Transplantation is usually the last option for patients with chronic respiratory conditions in the late stages of the disease. Pulmonary rehabilitation and, particularly, endurance training, is a cornerstone in the management of these patients both during the pre-operative as well as the post-operative period as it improves cardiopulmonary fitness, muscle mass, muscle strength, health-related quality of life and potentially, survival. However, very few studies have been published addressing which modality of training, intensity, frequency or duration of training provides the best possible results in these patients. Therefore, the objective of this study was to compare two training modalities (treadmill walking versus cycle-ergometry) on functional capacity, muscle strength and lung function.
- Conditions
- Lung Transplantation
- Being tested
- Exercise Therapy
- Keywords
- Exercise Therapy, Physical Therapy Modalities, Functional Capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyOther
Endurance training in the form of treadmill/cycle-ergometry
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Training | Experimental | Participants in the treadmill training group will perform endurance training during the post-operative period using a treadmill (Salter Housewares, UK) for a minimum of 20 sessions. Intensity of training will be set according to 80% of the mean speed achieved during the 6MWT for a targeted time of 30 minutes. Intensity and duration will be adapted to the participant's physical condition, especially during the first week.
After the endurance training, participants will perform resistance training for 20 - 30 minutes for conditioning of the main muscles in the upper and lower limbs using elastic bands, dumbbells and body-weight exercises. Intensity will progressively increase up to 70% of the maximum isometric strength measured with a hand-held dynamometer. Volume of training will also increase from 1 to 3 sets of 12 repetitions each. When needed patients will also be taught breathing exercises and airway clearance techniques. Receives: Other: Exercise Therapy |
| Cyclo-ergometry Training | Active comparator | Participants in this group will perfom endurance training during the post-operative period using a cycle ergometer (Monark 828e, Monark AB, Sweeden) for a minimum of 20 sessions. Intensity of training will be set according to the results of a symptom-limited incremental cycle-ergometry test performed on the first day to achieve 80% of the maximal workload obtained for a targeted time of 30 minutes. Intensity and duration will be adapted to the participant's physical condition, especially during the first week. Participants in this group will also perfom resistance training and breathing exercises as in the treadmill training group. Receives: Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
Distance covered during the 6 Minute Walk Test performed according to the American Thoracic Guidelines.
Measured: 1 month
Secondary outcomes (8)
6 Minute Walk Test
Distance covered with the 6 Minute Walk Test performed according to the American Thoracic Guidelines.
Measured: 3 Months
Maximal isometric strength
Isometrical maximal strength of the brachial biceps and quadriceps muscle of both dominant and non-dominant limbs. Maximal isometric strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Model 01165) and will be presented in kilograms
Measured: 1 and 3 months
Sit-to-stand
Number of times the patient can stand up from a chair and sit back in 30 seconds
Measured: 1 and 3 months
Forced Expiratory Volume 1st second (FEV1)
Changes in Forced Expiratory Volume in the 1st second assessed during a forced spirometry test performed according to the international guidelines.
Measured: 1 and 3 months
Incremental Symptom-Limited Test
Incremental symptom-limited test performed on a cycle-ergometry with a 5-10W increase per minute up to maximal tolerance. Patient was monitorised during the test for both heart rate and oxygen saturation.
Measured: 1 and 3 months
Maximal inspiratory and expiratory pressures
Maximal inspiratory and expiratory pressures performed with the respiratory muscles
Measured: 1 and 3 months
Forced Expiratory Capacity (FVC)
Changes in forced expiratory capacity assessed during a forced spirometry test performed according to the international guidelines.
Measured: 1 and 3 months
Peak Expiratory Flow (PEF)
Changes in peak expiratory flow assessed during a forced spirometry test performed according to the international guidelines.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 May 2016
- Primary completion30 May 2019
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Gimenez Moolhuyzen, University Hospital A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244305
- Sponsor's protocol ID
- EGM-TXP-2016
- Status last verified
- Jan 2020
- First submitted
- 27 Dec 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endurance Training in Patients Undergoing Lung Transplantation: Differences Between Treadmill and Cycle Ergometry Training
- ClinicalTrials.gov ID
- NCT04244305
- Acronym / sponsor ID
- EGM-TXP-2016
- Conditions
- Lung Transplantation
- Keywords
- Exercise Therapy, Physical Therapy Modalities, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital A CoruñaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 28 Jan 2020 (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.
Lung Transplantation is usually the last option for patients with chronic respiratory conditions in the late stages of the disease. Pulmonary rehabilitation and, particularly, endurance training, is a cornerstone in the management of these patients both during the pre-operative as well as the post-operative period as it improves cardiopulmonary fitness, muscle mass, muscle strength, health-related quality of life and potentially, survival. However, very few studies have been published addressing which modality of training, intensity, frequency or duration of training provides the best possible results in these patients. Therefore, the objective of this study was to compare two training modalities (treadmill walking versus cycle-ergometry) on functional capacity, muscle strength and lung function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill Training | Experimental | Other: Exercise TherapyParticipants in the treadmill training group will perform endurance training during the post-operative period using a treadmill (Salter Housewares, UK) for a minimum of 20 sessions. Intensity of training will be set according to 80% of the mean speed achieved during the 6MWT for a targeted time of 30 minutes. Intensity and duration will be adapted to the participant's physical condition, especially during the first week. After the endurance training, participants will perform resistance training for 20 - 30 minutes for conditioning of the main muscles in the upper and lower limbs using elastic bands, dumbbells and body-weight exercises. Intensity will progressively increase up to 70% of the maximum isometric strength measured with a hand-held dynamometer. Volume of training will also increase from 1 to 3 sets of 12 repetitions each. When needed patients will also be taught breathing exercises and airway clearance techniques. |
| Cyclo-ergometry Training | Active comparator | Other: Exercise TherapyParticipants in this group will perfom endurance training during the post-operative period using a cycle ergometer (Monark 828e, Monark AB, Sweeden) for a minimum of 20 sessions. Intensity of training will be set according to the results of a symptom-limited incremental cycle-ergometry test performed on the first day to achieve 80% of the maximal workload obtained for a targeted time of 30 minutes. Intensity and duration will be adapted to the participant's physical condition, especially during the first week. Participants in this group will also perfom resistance training and breathing exercises as in the treadmill training group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing lung transplantation at the Thoracic Surgery Unit of the Hospital Clínico Universitario de A Coruña.
- Adults > 18 years.
- Ability to attend post-surgery exercise training for a minimum period of one month.
- Sign informed consent.
Key exclusion criteria (2 listed)
- Torpid post-operative recovery with a prolonged stay at the Post-Anaesthesia Care Unit > 12 days.
- Diagnosed with intensive care unit acquired muscle weakness.
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 |
|---|---|---|
| Exercise TherapyEndurance training in the form of treadmill/cycle-ergometry | Other | Cyclo-ergometry Training, Treadmill Training |
Primary outcome
6 Minute Walk Test
Time frame: 1 month
Distance covered during the 6 Minute Walk Test performed according to the American Thoracic Guidelines.
8 secondary outcomes
6 Minute Walk Test
Time frame: 3 Months
Maximal isometric strength
Time frame: 1 and 3 months
Sit-to-stand
Time frame: 1 and 3 months
Forced Expiratory Volume 1st second (FEV1)
Time frame: 1 and 3 months
Incremental Symptom-Limited Test
Time frame: 1 and 3 months
Maximal inspiratory and expiratory pressures
Time frame: 1 and 3 months
Forced Expiratory Capacity (FVC)
Time frame: 1 and 3 months
Peak Expiratory Flow (PEF)
Time frame: 1 and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy in people with Lung Transplantation, run by University Hospital A Coruña.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
6 Minute Walk Test (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2020.