Clinical Trials Directory

Trials / Completed

CompletedNCT03584620

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

The Effects of Inspiratory Muscle Training on Physical Activity and Quality of Life in Lung Transplantation Candidates

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Istanbul Medipol University Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERInspiratory muscle trainingInspiratory 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 measurement, 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.
OTHERPulmonary rehabilitationAerobic 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

Timeline

Start date
2016-04-01
Primary completion
2017-03-01
Completion
2017-05-01
First posted
2018-07-12
Last updated
2019-05-30

Source: ClinicalTrials.gov record NCT03584620. Inclusion in this directory is not an endorsement.