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Clinical Trials/NCT03584620
NCT03584620
Completed
Not Applicable

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

Istanbul Medipol University Hospital0 sites34 target enrollmentApril 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Transplantation
Sponsor
Istanbul Medipol University Hospital
Enrollment
34
Primary Endpoint
Change from baseline International physical activity questionary short form (IPAQ-SF) score at 3-months
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
May 1, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

esra pehlivan

Principal investigator

Istanbul Medipol University Hospital

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,

Outcomes

Primary Outcomes

Change from baseline International physical activity questionary short form (IPAQ-SF) score at 3-months

Time Frame: 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

Time Frame: Three months

The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)

Secondary Outcomes

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

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