CClinicalTrials.gg
Status unknownNCT04244305Updated Jan 29, 2020

Endurance Training in Patients Undergoing Lung Transplantation

An interventional study of Exercise Therapy in Lung Transplantation, sponsored by University Hospital A Coruña. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-29.

Sponsored by University Hospital A Coruña · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled May 2016, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Lung Transplantation

Keywords

  • Exercise Therapy
  • Physical Therapy Modalities
  • Functional Capacity
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In context

Lead sponsor

University Hospital A Coruña is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Torpid post-operative recovery with a prolonged stay at the Post-Anaesthesia Care Unit > 12 days.
  • Diagnosed with intensive care unit acquired muscle weakness.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Treadmill Training

    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.

    Other: Exercise Therapy

  • Active comparator
    Cyclo-ergometry Training

    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.

    Other: Exercise Therapy

Interventions

  • OtherExercise Therapy

    Endurance training in the form of treadmill/cycle-ergometry

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What researchers measure

Primary outcomes

  1. 6 Minute Walk Test

    Distance covered during the 6 Minute Walk Test performed according to the American Thoracic Guidelines.

    Time frame: 1 month

Secondary outcomes

  1. 6 Minute Walk Test

    Distance covered with the 6 Minute Walk Test performed according to the American Thoracic Guidelines.

    Time frame: 3 Months

  2. 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

    Time frame: 1 and 3 months

  3. Sit-to-stand

    Number of times the patient can stand up from a chair and sit back in 30 seconds

    Time frame: 1 and 3 months

  4. 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.

    Time frame: 1 and 3 months

  5. 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.

    Time frame: 1 and 3 months

  6. Maximal inspiratory and expiratory pressures

    Maximal inspiratory and expiratory pressures performed with the respiratory muscles

    Time frame: 1 and 3 months

  7. Forced Expiratory Capacity (FVC)

    Changes in forced expiratory capacity assessed during a forced spirometry test performed according to the international guidelines.

    Time frame: 1 and 3 months

  8. Peak Expiratory Flow (PEF)

    Changes in peak expiratory flow assessed during a forced spirometry test performed according to the international guidelines.

    Time frame: 1 and 3 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04244305
Lead sponsor
University Hospital A Coruña
Responsible party
Esther Gimenez Moolhuyzen (Principal Investigator, University Hospital A Coruña) — Principal investigator
First posted
Jan 28, 2020
Start date
May 1, 2016
Primary completion
May 30, 2019
Completion
May 1, 2020 (estimated)
Last update
Jan 29, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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