Endurance Training in Patients Undergoing Lung Transplantation

Lung Transplantation Clinical Trial

Official title:

Endurance Training in Patients Undergoing Lung Transplantation: Differences Between Treadmill and Cycle Ergometry Training

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04244305
• Other study ID #: EGM-TXP-2016
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: May 1, 2020

Study information

• Verified date: January 2020
• Source: University Hospital A Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Other:
• Exercise Therapy
Endurance training in the form of treadmill/cycle-ergometry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital A Coruña

Outcome

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