Endurance Training in Patients Undergoing Lung Transplantation

NCT ID: NCT04244305

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2020-05-01

Brief 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.

Conditions

Lung Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Therapy

Intervention Type: OTHER

Endurance training in the form of treadmill/cycle-ergometry

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.

Group Type: ACTIVE_COMPARATOR

Exercise Therapy

Intervention Type: OTHER

Endurance training in the form of treadmill/cycle-ergometry

Interventions

Exercise Therapy

Endurance training in the form of treadmill/cycle-ergometry

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital A Coruña

OTHER

Sponsor Role: lead

Responsible Party

Esther Gimenez Moolhuyzen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EGM-TXP-2016

Identifier Type: -

Identifier Source: org_study_id