Endurance Training in Patients Undergoing Lung Transplantation

NCT04244305 | Unknown

• 1 other identifier: EGM-TXP-2016
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Keywords

Exercise Therapy; Physical Therapy Modalities; Functional Capacity

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test

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

  1 month

Secondary Outcomes (8)

• 6 Minute Walk Test

  3 Months

• Maximal isometric strength

  1 and 3 months

• Sit-to-stand

  1 and 3 months

• Forced Expiratory Volume 1st second (FEV1)

  1 and 3 months

• Incremental Symptom-Limited Test

  1 and 3 months

Study Arms (2)

Treadmill Training

EXPERIMENTAL

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

Cyclo-ergometry Training

ACTIVE COMPARATOR

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

Exercise Therapy OTHER

Endurance training in the form of treadmill/cycle-ergometry

Cyclo-ergometry Training; Treadmill Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital A Coruña: lead

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors were blinded to group allocation of the participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 28, 2020
• Study Start: May 1, 2016
• Primary Completion: May 30, 2019
• Study Completion: May 1, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share