Clinical trial NCT03584620: The Effects of IMT on Physical Activity and Quality of Life in LTx Candidates
Official title: The Effects of Inspiratory Muscle Training on Physical Activity and Quality of Life in Lung Transplantation Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplantation
Inspiratory Muscle Training
Keywords: lung transplantation
inspiratory muscle training
pulmonary rehabilitation
quality of life
physical activity
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Change from baseline International physical activity questionary short form (IPAQ-SF) score at 3-months
timeFrame: Three months
measure: Change from baseline Saint George Respiratory Questionaire score at 3-months
timeFrame: Three months
Secondary outcomes:
measure: Change from baseline distance covered in six minute walking test at 3-months
timeFrame: Three months
measure: Change from baseline Maximum Inspiratory Pressure (MIP) at 3-months
timeFrame: Three months
Other outcomes:
Locations:
Study officials:
References: