The Effects of IMT on Exercise Capacity, Dyspnea and Lung Functions in LTx

NCT03505697 | Completed

• 1 other identifier: esrapehlivan
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inspiratory Muscle Training (IMT), which is used to strengthen the respiratory muscles, is one of the techniques used in PR. It is mostly used in patients with chronic obstructive pulmonary disease, and has been shown to be beneficial for functionality and also for relieving dyspnea perception. It is reported in the guidelines that IMT has additional benefit for endurance in COPD patients. However, there are no studies related to its use and effectiveness in lung transplantation. In this study, we hoped to increase these known benefits by adding IMT to the standard Pulmonary Rehabilitation. There are two main objectives of this study:

1. 1.to examine the effect of respiratory muscle training on exercise capacity in lung transplantation candidates,
2. 2.to compare dyspnea perception and lung function changes between the IMT+PR group and the PR group.

Conditions

Lung Transplant; Inspiratory Muscle Training

Keywords

rehabilitation; exercise; maximal inspiratory pressure; 6-minute walk test

Outcome Measures

Primary Outcomes (4)

• Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months

  The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.

  Three months

• Change from baseline Maximum Expiratory Pressure (MEP) at 3-months

  The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.

  Three months

• Change from baseline distance covered in six minute walking test at 3-months

  The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk. Before and after the test, oxygen saturation, heart rate, Borg fatigue rating, and walking distance were recorded.

  Three months

• Change from baseline Modified Medical Research Council (mMRC) Dyspnea Scale score at 3-months

  Dyspnea perceptions during the activities of daily living were assessed with modified Medical Research Council (mMRC) scale.

  Three months

Secondary Outcomes (3)

• Change from baseline Forced Vital Capacity (FVC) at 3-months

  Three months

• Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 3-months

  Three months

• Change from baseline alveolar volume ratio of carbonmonoxide diffusion capacity (DLCO/VA) at 3-months

  Three months

Study Arms (2)

IMT+PR Group

EXPERIMENTAL

Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training. In addition standard pulmonary rehabilitation, patients received inspiratory muscle training.

Other: inspiratory muscle training; Other: Pulmonary rehabilitation

PR group

EXPERIMENTAL

Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training.

Other: Pulmonary rehabilitation

Interventions

inspiratory muscle training OTHER

Inspiratory Muscle Training was performed with an exercise tool (Powerbreath®) with a resistance range of 0-90. The training intensity was started with 30% of the Maximum Inspiratory Pressure (MIP) value obtained as a result of the mouth pressure measurement16, training was progressively increased from 30% to 60% considering that they were terminal-stage pulmonary disease patients. Patients were asked to perform IMT for 15 minutes, twice a day, 7 days a week, for 3 months.

IMT+PR Group

Pulmonary rehabilitation OTHER

Aerobic training:The aerobic exercise program consists of treadmill walking, cycle ergometer and arm ergometer training. Group exercises were performed in sets of 15 minutes each with three exercise modalities. Strength training:It is recommended that resistance targets are set at loads equivalent to 20 to 40% of a 1-repetition maximum (1RM) maneuver and performed between 8 to 12 repetitions for 1 to 2 sets per session. Home exercise programme:The program included breathing exercises (local expansion exercises, diaphragmatic breathing and pursed lip breathing), free walking, upper and lower extremity strengthening exercises with Thera-Band

IMT+PR Group; PR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of terminally severe lung disease,
• being listed for lung transplantation,
• medically stable,
• had no orthopedic or cardiac problems that would prevent them from exercising
• had no transfer problem to the PR centre.

You may not qualify if:

• Malignancy in the last 2 years,
• Other advanced major organ / system dysfunction that can not be treated outside the lung,
• Untreated non-pulmonary infection,
• Disputed medical treatment discontinuity,
• Untreatable psychiatric illness or psychosocial condition that interferes with treatment compliance,
• No appropriate, reliable social support,

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 23, 2018
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 23, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share