Protocol for long-term effect of pulmonary rehabilitation under nintedanib in idiopathic pulmonary fibrosis.

BACKGROUND: Pulmonary rehabilitation causes short-term improvement in exercise capacity, dyspnoea and health-related quality of life in idiopathic pulmonary fibrosis (IPF); however, long-term maintenance of the improvement is difficult. Nintedanib, an antifibrotic drug, has been shown to delay the worsening of pulmonary function in IPF. Therefore, the concomitant use of nintedanib with pulmonary rehabilitation is anticipated to contribute to the long-term maintenance of the pulmonary rehabilitation effects. The long-term effect of pulmonary rehabilitation under nintedanib treatment in IPF (FITNESS) study is a multicenter, randomised, prospective, parallel-group, open-label trial. METHODS: The study will enrol 84 patients with IPF who have been treated with nintedanib. Patients in the pulmonary rehabilitation group will receive a programmed short-term induction pulmonary rehabilitation programme, followed by a maintenance home-based pulmonary rehabilitation programme, while patients in the control group will receive usual outpatient care. Patients in both groups will continue to receive nintedanib treatment throughout the study period. The primary end-point of the study is to compare the change in the 6-min walk distance from the baseline to 12 months between the pulmonary rehabilitation and control groups. The main secondary end-point is endurance exercise time, measured using a bicycle ergometer. DISCUSSION: FITNESS is the first randomised controlled study to evaluate the long-term effects of pulmonary rehabilitation in IPF treated with nintedanib. This study will address the hypothesis that concomitant use of nintedanib contributes to the maintenance of long-term effects of pulmonary rehabilitation, thus leading to a comprehensive therapeutic approach of "nintedanib and pulmonary rehabilitation" in the antifibrotic era.

Daily physical activity affects exercise capacity in patients with idiopathic pulmonary fibrosis.

[Purpose] The aim of this study was to determine which factors, including pulmonary, physical, and mental functions; dyspnea; and daily physical activity (PA) affect the 6-minute walk distance (6MWD) in IPF patients. [Subjects and Methods] The pulmonary, physical, and mental functions; dyspnea; PA; and 6MWD were assessed in 38 outpatients with IPF. PA was represented by the mean number of steps per day. [Results] The mean 6MWD was 443.8 m (SD, 98.5), and the mean number of steps per day showing PA was 5148.4 (SD, 3295.7). The 6MWD was correlated with age, base dyspnea index, vital capacity (VC), diffusion capacity of carbon monoxide, quadriceps force (QF), dyspnea during the 6-minute walk test, and PA. Stepwise multiple regression analysis revealed that VC (ß=0.382), QF (ß=0.272), and PA (ß=0.574) were contributing factors of the 6MWD. [Conclusion] In patients with IPF, PA has a greater effect on the 6MWD than VC and QF. The evaluation of daily PA, in addition to physiological and muscle functions, is important in patients with IPF.

Factors affecting dyspnea after the 6-minute walk test in idiopathic pulmonary fibrosis patients presenting with exercise-induced hypoxemia.

[Purpose] The current study aimed to investigate factors affecting dyspnea after the 6-minute walk test (6MWT) in idiopathic pulmonary fibrosis (IPF) patients presenting with hypoxemia. [Subjects and Methods] The subjects were IPF out-patients with stable symptoms whose percutaneous arterial oxygen saturation fell to 88% during the 6MWT test. Quadriceps force, 6-minute walk distance (6MWD), dyspnea after the 6MWT, and leg fatigue (LF) were evaluated as exercise-related variables. [Results] The subjects were 14 patients (mean age 73.6 ± 6.3 years) classed based on the modified Medical Research Council dyspnea scale as 0 for 2 patients, 1 for 6 patients, and 2 for 6 patients, indicating that the patients were comparatively mild cases. Mean 6MWD was 408.9 ± 102.4 m, and dyspnea after the 6MWT and LF were 3.0 ± 1.4 and 1.5 ± 1.5, respectively. Dyspnea after the 6MWT was correlated with vital capacity (VC), forced vital capacity, and LF. Stepwise multiple regression analysis identified VC and LF as factors significantly affecting dyspnea after the 6MWT. [Conclusion] The results of this study demonstrated that it is necessary to evaluate both pulmonary function and LF in IPF patients presenting with exercise-induced hypoxemia and exertional dyspnea.

Upper extremity muscle tone and response of tidal volume during manually assisted breathing for patients requiring prolonged mechanical ventilation.

[Purpose] The aim of the present study was to examine, in patients requiring prolonged mechanical ventilation, if the response of tidal volume during manually assisted breathing is dependent upon both upper extremity muscle tone and the pressure intensity of manually assisted breathing. [Subjects] We recruited 13 patients on prolonged mechanical ventilation, and assessed their upper extremity muscle tone using the modified Ashworth scale (MAS). The subjects were assigned to either the low MAS group (MAS≤2, n=7) or the high MAS group (MAS≥3, n=6). [Methods] The manually assisted breathing technique was applied at a pressure of 2 kgf and 4 kgf. A split-plot ANOVA was performed to compare the tidal volume of each pressure during manually assisted breathing between the low and the high MAS groups. [Results] Statistical analysis showed there were main effects of the upper extremity muscle tone and the pressure intensity of the manually assisted breathing technique. There was no interaction between these factors. [Conclusion] Our findings reveal that the tidal volume during the manually assisted breathing technique for patients with prolonged mechanical ventilation depends upon the patient's upper extremity muscle tone and the pressure intensity.

Complications after video-assisted thoracic surgery in patients with pulmonary nontuberculous mycobacterial lung disease who underwent preoperative pulmonary rehabilitation.

[Purpose] Video-assisted thoracic surgery and preoperative pulmonary rehabilitation are effective in preventing postoperative complications in patients with cardiopulmonary disease. The present study aims to elucidate the presence of postoperative pneumonia and atelectasis in patients with nontuberculous mycobacterial lung disease who underwent lung resection with video-assisted thoracic surgery and preoperative pulmonary rehabilitation. [Subjects and Methods] Nineteen patients with nontuberculous mycobacterial lung disease who had undergone lung resection with video-assisted thoracic surgery and preoperative pulmonary rehabilitation were enrolled in this study. The presence of postoperative pneumonia and atelectasis was evaluated, and preoperative and postoperative pulmonary functions were compared. [Results] Postoperative pneumonia and postoperative atelectasis were not observed. Decreases of pulmonary function were 5.9% (standard deviation, 8.5) in forced vital capacity (percent predicted) and 9.6% (standard deviation, 11.1) in forced expiratory volume in 1 s (percent predicted). [Conclusion] The present study indicates that the combination of lung resection with video-assisted thoracic surgery and preoperative pulmonary rehabilitation in patients with nontuberculous mycobacterial lung disease may be effective in preventing postoperative complications.

Test-retest reliability of expiratory abdominal compression with a handheld dynamometer in patients with prolonged mechanical ventilation.

[Purpose] The present study aimed to examine the test-retest reliability of expiratory abdominal compression with a handheld dynamometer in patients with prolonged mechanical ventilation. [Subjects and Methods] We recruited 18 patients with prolonged mechanical ventilation. All patients had impaired consciousness. The mode of the ventilator was synchronized intermittent mandatory ventilation. The abdomen above the navel was vertically compressed using a handheld dynamometer in synchronization with expiration. Expiratory abdominal compression was performed two times. We measured the tidal volume during expiratory abdominal compression. There was an interval of 5 minutes between the first and second measurements. Intraclass correlation coefficient (ICC) and Bland-Altman analysis were performed to examine the test-retest reliability of expiratory abdominal compression with a handheld dynamometer. [Results] The test-retest reliability of expiratory abdominal compression was excellent (ICC(1, 1): 0.987). Bland-Altman analysis showed that there was no fixed bias and no proportional bias. [Conclusion] The findings of this study suggest that expiratory abdominal compression with a handheld dynamometer is reliable and useful for patients with respiratory failure and prolonged mechanical ventilation.

Parameters affecting the tidal volume during expiratory abdominal compression in patients with prolonged tracheostomy mechanical ventilation.

[Purpose] The aim of this study was to clarify physical parameters affecting the tidal volume during expiratory abdominal compression in patients with prolonged tracheostomy mechanical ventilation. [Methods] Eighteen patients with prolonged mechanical ventilation were included in this study. Expiratory abdominal compression was performed on patients lying in a supine position. The abdomen above the navel was vertically compressed in synchronization with expiration and released with inspiration. We measured the tidal volume during expiratory abdominal compression. [Results] The mean tidal volume during expiratory abdominal compression was higher than that at rest (430.6 ± 127.1 mL vs. 344.0 ± 94.3 mL). The tidal volume during expiratory abdominal compression was correlated with weight, days of ventilator support, dynamic compliance and abdominal expansion. Stepwise multiple regression analysis revealed that weight (ß = 0.499), dynamic compliance (ß = 0.387), and abdominal expansion (ß = 0.365) were factors contributing to the tidal volume during expiratory abdominal compression. [Conclusion] Expiratory abdominal compression increased the tidal volume in patients with prolonged tracheostomy mechanical ventilation. The tidal volume during expiratory abdominal compression was influenced by each of the pulmonary conditions and the physical characteristics.

Measuring seated hip extensor strength using a handheld dynamometer: an examination of the reliability and validity of the protocol.

[Purpose] The purpose of this study was to examine the reliability and validity of measurements of hip extensor muscle strength using a handheld dynamometer (HHD) with subjects in a sitting position. In doing so, we also aimed to establish a modified method of measurement for patients with flexion contractures in the trunk and lower extremities. [Subjects and Methods] In 20 healthy males, hip extensor muscle strength was measured using a handheld dynamometer in sitting, prone, and standing positions by contracting the hip extensor muscle isometrically with the knee flexed at 90 degrees. For each position, we investigated the relative and absolute reliability and validity of the measurements, and compared muscle strength between the different positions. [Results] The reliability and validity of measurements were highest in the sitting position and higher in both the sitting and standing positions as compared with those in the prone position. [Conclusion] Our findings suggest that measurements taken in a sitting position are accurate in assessing hip extensor muscle strength and would be applicable to patients with flexion contractures in the trunk and lower extremities.

Comparison of changes in tidal volume associated with expiratory rib cage compression and expiratory abdominal compression in patients on prolonged mechanical ventilation.

[Purpose] This study was designed to compare and clarify the relationship between expiratory rib cage compression and expiratory abdominal compression in patients on prolonged mechanical ventilation, with a focus on tidal volume. [Subjects and Methods] The subjects were 18 patients on prolonged mechanical ventilation, who had undergone tracheostomy. Each patient received expiratory rib cage compression and expiratory abdominal compression; the order of implementation was randomized. Subjects were positioned in a 30° lateral recumbent position, and a 2-kgf compression was applied. For expiratory rib cage compression, the rib cage was compressed unilaterally; for expiratory abdominal compression, the area directly above the navel was compressed. Tidal volume values were the actual measured values divided by body weight. [Results] Tidal volume values were as follows: at rest, 7.2 ± 1.7 mL/kg; during expiratory rib cage compression, 8.3 ± 2.1 mL/kg; during expiratory abdominal compression, 9.1 ± 2.2 mL/kg. There was a significant difference between the tidal volume during expiratory abdominal compression and that at rest. The tidal volume in expiratory rib cage compression was strongly correlated with that in expiratory abdominal compression. [Conclusion] These results indicate that expiratory abdominal compression may be an effective alternative to the manual breathing assist procedure.