Endurance Training in Patients Undergoing Lung Transplantation

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplantation
• Intervention / Treatment: Other: Exercise Therapy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Endurance training in the form of treadmill/cycle-ergometry
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; Endurance training in the form of treadmill/cycle-ergometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Test	Distance covered during the 6 Minute Walk Test performed according to the American Thoracic Guidelines.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Test	Distance covered with the 6 Minute Walk Test performed according to the American Thoracic Guidelines.	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	1 and 3 months
Sit-to-stand	Number of times the patient can stand up from a chair and sit back in 30 seconds	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.	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.	1 and 3 months
Maximal inspiratory and expiratory pressures	Maximal inspiratory and expiratory pressures performed with the respiratory muscles	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.	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.	1 and 3 months

Collaborators and Investigators

• Sponsor: University Hospital A Coruña

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 30, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Physical Therapy Modalities; Exercise Therapy; Functional Capacity
• Other Study ID Numbers: EGM-TXP-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No