Lung Transplantation Clinical Trial
Official title:
Endurance Training in Patients Undergoing Lung Transplantation: Differences Between Treadmill and Cycle Ergometry Training
Verified date | January 2020 |
Source | University Hospital A Coruña |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | May 1, 2020 |
Est. primary completion date | May 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: - Torpid post-operative recovery with a prolonged stay at the Post-Anaesthesia Care Unit > 12 days. - Diagnosed with intensive care unit acquired muscle weakness. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital A Coruña |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6 Minute Walk Test | Distance covered during the 6 Minute Walk Test performed according to the American Thoracic Guidelines. | 1 month | |
Secondary | 6 Minute Walk Test | Distance covered with the 6 Minute Walk Test performed according to the American Thoracic Guidelines. | 3 Months | |
Secondary | 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 | 1 and 3 months | |
Secondary | Sit-to-stand | Number of times the patient can stand up from a chair and sit back in 30 seconds | 1 and 3 months | |
Secondary | 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. | 1 and 3 months | |
Secondary | 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. | 1 and 3 months | |
Secondary | Maximal inspiratory and expiratory pressures | Maximal inspiratory and expiratory pressures performed with the respiratory muscles | 1 and 3 months | |
Secondary | Forced Expiratory Capacity (FVC) | Changes in forced expiratory capacity assessed during a forced spirometry test performed according to the international guidelines. | 1 and 3 months | |
Secondary | Peak Expiratory Flow (PEF) | Changes in peak expiratory flow assessed during a forced spirometry test performed according to the international guidelines. | 1 and 3 months |
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