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

NCT03584620 | Completed

• 1 other identifier: IMT_LTx_PA_QOL
• 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, 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

Conditions

Lung Transplantation; Inspiratory Muscle Training

Keywords

lung transplantation; inspiratory muscle training; pulmonary rehabilitation; quality of life; physical activity

Outcome Measures

Primary Outcomes (2)

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

  Three months

• Change from baseline Saint George Respiratory Questionaire score at 3-months

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

  Three months

Secondary Outcomes (2)

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

  Three months

• Change from baseline Maximum Inspiratory Pressure (MIP) 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 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.

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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: July 12, 2018
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 30, 2019

Record last verified: 2018-06