The Effects of IMT on Physical Activity and Quality of Life in LTx Candidates

Not Applicable

Completed

• Conditions: Inspiratory Muscle Training; Lung Transplantation
• Interventions: Other: Pulmonary rehabilitation; Other: Inspiratory muscle training

• Registration Number: NCT03584620
• Lead Sponsor: Istanbul Medipol University Hospital

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, investigators hoped to increase these known benefits by adding IMT to the standard Pulmonary Rehabilitation.

There are two main objectives of this study:

* to examine the effect of inspiratory muscle training on physical activity status and quality of life in lung transplantation candidates,

* to compare physical activity and quality of life changes between the IMT+PR group and the PR group

Detailed Description

The patients in the lung transplantation waiting list were included the study. These patients were with severe lung disease requiring transplantation, and that the intervention was undertaken before any lung transplantation. The patients were eligible for inclusion if participitants have: 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 and had no transfer problem to the PR centre.

Participants who meet the study inclusion criteria and complete the baseline assessments were randomly allocated into one of the two groups: namely Pulmonary Rehabilitation plus Inspiratory Muscle Training Group (IMT+PR) or Pulmonary Rehabilitation Group (PR) using a numbered series of 34 prefilled envelops specifying group assignment generated by a computer-based program.

All patients underwent supervised PR program on 2 days per week for 3 months. Apart from that, participitant were asked to perform the home exercise program which was scheduled as 3 days per week and fill out the exercise follow-up form. The study group was provided with IMT in addition to the standard program.

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-05-01
• Status Verified: 2018-06
• Study First Submitted: 2018-06-30
• Study First Submitted QC: 2018-06-30
• Study First Posted: 2018-07-12
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• 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.

Exclusion Criteria

• 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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PR group	Pulmonary rehabilitation	Patients received a 3-month standard hospital-based Pulmonary Rehabilitation included aerobic and strength training.
IMT+PR Group	Inspiratory muscle training	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.
IMT+PR Group	Pulmonary rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline International physical activity questionary short form (IPAQ-SF) score at 3-months	Three months	including seven questions on the frequency and duration of time spent in physical activity in the past 7 days to calculate a score for each domain (walking, moderate-intensity activities and vigorous-intensity activities) and an overall grand total expressed in MET-minutes/week.
Change from baseline Saint George Respiratory Questionaire score at 3-months	Three months	The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)

Secondary Outcome Measures

Name	Time	Method
Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months	Three 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.
Change from baseline distance covered in six minute walking test at 3-months	Three 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.