scholarly journals Efficacy and Safety of Jin-Shui Huan-Xian Granule for Idiopathic Pulmonary Fibrosis: Study Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Author(s):  
Shu-guang Yang ◽  
Xue-qing Yu ◽  
Jiansheng Li ◽  
Yang Xie ◽  
Wei Zhang ◽  
...  

Abstract Background Idiopathic pulmonary fibrosis is a critical disease with poor prognosis. Although different studies have been conducted for the treatment of idiopathic pulmonary fibrosis, limited treatments are available. Jin-shui Huan-xian granule, which is a Chinese medicine herbal compound, has shown a promising efficacy in reducing frequencies of acute exacerbations, improving exercise capacity the quality of life of patients for idiopathic pulmonary fibrosis. Subjects and Methods: This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 312 idiopathic pulmonary fibrosis patients will be enrolled and randomly allocated to one of the two groups with 1:1. After a 2-week washout period, 52-week treatment will also be performed for all the patients. Patients in experimental group will be given Jin-shui Huan-xian granule with Jin-shui Huan-xian placebo for control group. Outcome measures including acute exacerbations, pulmonary function, dyspnea, exercise capacity, quality of life will be evaluated in this study. Discussion Based on our previous study, it is hypothesized that JHG will reduce the acute exacerbations, improve exercise capacity, pulmonary function, quality of life, delay the disease progression-free. High-level evidence-based support for TCM in IPF will also be obtained in this study. Trial registration: http:www.clinicaltrials.gov : NCT04187690. Register data: December 11, 2019.


Author(s):  
Jose Cerdán-de-las-Heras ◽  
Fernanda Balbino ◽  
Anders Løkke ◽  
Daniel Catalán-Matamoros ◽  
Ole Hilberg ◽  
...  

We investigated the usefulness and effectiveness of tele-rehabilitation on exercise capacity in patients with idiopathic pulmonary fibrosis (IPF). A randomized study was carried out, including stable patients with IPF for 3 months of tele-rehabilitation: video and chat consultations with a physiotherapist and workout sessions with a virtual physiotherapist agent (VAPA). Moreover, 6-minute walk test distance (6MWTD), forced vital capacity (FVC), diffusion capacity for carbon monoxide (DLCO), 7 days pedometry, Saint George Respiratory Questionnaire for interstitial lung disease, The King's Brief Interstitial Lung Disease Questionnaire, and General Anxiety Disorder 7 Questionnaire were tested before and after 3 months of tele-rehabilitation, as well as after 3 and 6 months follow-up. Patient satisfaction and adherence were also measured for tele-rehabilitation with VAPA. Twenty-nine patients aged 70.9 ± 8.6 years, male 72.4%, FVC% 83.5 ± 17.7, DLCO% 50.6 ± 13.0, 6MWTD 468.4 ± 14.8 were included. Fifteen patients were randomized to tele-rehabilitation with VAPA and 14 to the control group. Differences in 6MWTD between groups were at baseline (+10 m (p = 0.11)) and after 3 (+39.5m (p = 0.03)), 6 (+ 34.3m (p = 0.02)), and 9 months (+ 40.5m (p = 0.15)) follow-up. No difference was observed in pedometry and quality of life. Adherence was above 63%. Patient satisfaction was high. Tele-rehabilitation with VAPA appears to be useful in patients with IPF. Exercise capacity was better at follow up at 3 and 6 months compared with the control group. There was no change in quality of life or pedometry. Adherence and patient satisfaction were all high.





2020 ◽  
Author(s):  
Fei Jing ◽  
Haina Fan ◽  
Zhimin Zhao ◽  
Feng Xing ◽  
Yingchun He ◽  
...  

Abstract Background: Some patients with COVID-19 have been found pulmonary dysfunction and/or fibrosis in the recovery period, especially severe cases, but there are no certain drugs or treatment to cope with this situation. Previous studies proved the efficacy of FZHY on lung fibrosis induced by Bleomycin in animals and improvement of pulmonary function in COPD patients. We design this trial to carry out the clinical study that the effects of FZHY Tablets on pulmonary fibrosis and/or pulmonary function injury in the recovery period of COVID-19 and expect to improve the prognosis.Methods/design: This is a double-blind, placebo-controlled, randomized, multicenter clinical trial. It enrolls 160 patients who had been diagnosed with COVID-19, but currently they are negative for viral testing and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly divided equally into control group and experimental group. All patients are given basic treatment such as respiratory function rehabilitation training and vitamin C. The control group is given placebo of FZHY, and the experimental group is given FZHY. Each patient will be observed for 24 weeks and followed up for 8 weeks. The primary outcome for the trial is a composite endpoint consisting of lung function and HRCT. Secondary outcomes include clinical symptoms, oxygen saturation and quality of life assessment. Discussion: The trial is designed to test the hypothesis that treating pulmonary fibrosis or pulmonary dysfunction after SARS-CoV-2 infection with FZHY will improve the patient’s lung function or the pathological manifestation of pulmonary fibrosis, and improve the quality of life. Trial registration: Clinical Trials.gov, ID: NCT04279197. Registered on 12 April 2020.



2021 ◽  
Author(s):  
Zhe Wu ◽  
Winston Banya ◽  
Nazia Chaudhuri ◽  
Ira Jakupovic ◽  
Toby Maher ◽  
...  

Abstract Background: Idiopathic pulmonary fibrosis (IPF) is a progressive disease that leads to lung scarring, Cough is reported by 85% of patients with IPF and can be a distressing symptom with a significant impact on patients’ quality of life. There are no proven effective therapies for IPF related cough. While morphine is frequently used as a palliative agent for breathlessness in IPF, its effects on cough have never been tested. PAciFy Cough is a multicenter, double-blind, placebo-controlled, crossover trial of morphine sulfate for the treatment of cough in IPF. Methods: We will recruit 44 subjects with IPF prospectively from three interstitial lung disease units in the UK, namely the Royal Brompton Hospital, Manchester University NHS Foundation Trust (MFT) and Aintree University Hospital NHS Foundation Trust. Patients will be randomized (1:1) to either placebo twice daily or morphine sulfate 5mg twice daily for 14 days. They will then crossover after a 7 day washout period. The primary endpoint is the percent change in daytime cough frequency (coughs per hour) from baseline as assessed by objective cough monitoring at Day 14 of treatment.Discussion: This multicentre, randomised trial will assess the effect of opioids on cough counts and cough associated quality of life in IPF subjects. If proven to be an effective intervention, it represents a readily available treatment for patients.Trial registration: The study was approved by the UK Medicines and Healthcare Regulatory Agency (Ref: CTA 21268/0224/001-0001 – EUDRACT 2019-003571-19 – Protocol Number RBH2019/001) on 08 April 2020, in compliance with the European Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004 and its subsequent amendments. The study was provided with ethical approval by the London Brent Research Ethics Committee (Ref: 20/LO/0368) on 21 May 2020 and is registered with clinicaltrials.gov (NCT04429516) on 12 June 2020, available at https://clinicaltrials.gov/ct2/show/NCT04429516



Breathe ◽  
2016 ◽  
Vol 12 (2) ◽  
pp. 130-138 ◽  
Author(s):  
Baruch Vainshelboim

Key pointsExercise training has been proven to be a safe and effective behavioural intervention for prevention and rehabilitation of chronic conditions.Despite the complexity of the signs and symptoms presented in IPF, supervised exercise training is a feasible and effective treatment for clinical improvement.Emerging data show significant enhancements in exercise capacity, dyspnoea and quality of life among IPF patients after exercise training interventions.Understanding of the principles of exercise training and the pathophysiology of IPF are essential for effective exercise programme delivery.Educational aimsTo describe the current evidence supporting exercise training for IPF.To highlight the importance of exercise physiology principles in rehabilitation treatment of patients with IPF.To introduce an effective practical exercise programme for IPF.To discuss the possible underlying physiological mechanisms of training effects in IPF.Exercise is a well-documented safe and effective intervention for prevention and rehabilitation of chronic diseases. Idiopathic pulmonary fibrosis (IPF) is a chronic deadly lung disease associated with severe signs and symptoms, exercise intolerance, diminished quality of life and poor prognosis. In the short term, supervised exercise training programmes have demonstrated clinical benefits in improving exercise capacity, dyspnoea and quality of life in patients with IPF. The underlying mechanisms of chronic adaption to a regular exercise regimen in IPF have yet to be well described and require further investigation. The available data underscore the importance of implementing training principles to target the pathophysiological impairments of IPF in order to optimise training adaption and enhance the outcomes. The current exercise training data in IPF provide sufficient evidence of clinical benefit for consideration to be given to recommending exercise-based pulmonary rehabilitation as standard of care for IPF.



2020 ◽  
Vol 12 (3) ◽  
pp. 1041-1055 ◽  
Author(s):  
Masatoshi Hanada ◽  
Karina Tamy Kasawara ◽  
Sunita Mathur ◽  
Dmitry Rozenberg ◽  
Ryo Kozu ◽  
...  


2021 ◽  
Author(s):  
Xuan Chen ◽  
Cuiping Fu ◽  
Xiongbiao Wang ◽  
Meng Sun ◽  
Wei Zhang ◽  
...  

BACKGROUND Baduanjin has been applied in health and rehabilitation and gained a growing number of practitioners both in home and abroad.To explore the effect of home based and video guided PR training, our research determined to evaluate Baduanjin on moderate COPD patients and explore its synergy effect with IMT in inducing improvement in pulmonary function, exercise capacity and quality of life. OBJECTIVE We cooperated Baduanjin as a pulmonary rehabilitation intervention for patients with moderate COPD. We evaluated its efficiency on pulmonary function, exercise capacity, quality of life in moderate COPD patients. METHODS This was a multi-centered, prospective, randomized controlled trial. Moderate COPD patients were collected from ten hospitals in Shanghai. After a two-week run-in period, all eligible participants were randomly assigned into Baduanjin training group, Tri-Ball® Respiratory training group, Baduanjin combined with respiratory training group and control group. The outcome assessments were conducted at four time points, namely at the 4th week and 8th week during the intervention, after 12-week pulmonary rehabilitation program and 3-month follow up. RESULTS A total of 240 participants were recruited in this study. 217 moderate COPD patients were analyzed in this study. After 12-week PR intervention, improvement was noticed in pulmonary function (FEV1%), exercise capacity (6MWD) and quality of life (CAT, SGRQ and T.C.M score) in Baduanjin training group when compared to the control group (P<0.05). Combining Baduanjin with additional inspiratory muscle training exerted better result than Banduanjin or inrespiratory muscle training alone (P<0.05). Improved performances after 12-week PR intervention were maintained after 3-month follow up in this research. Compared with the control group, drastically more percentage of participants with mMRC≤2 in combination training group was observed (mMRC≤2, 55(100%) vs 44(83.02%); mMRC>2, 0(0%) vs 9 (16.98%), P<0.01). CONCLUSIONS The results of this trial suggested that, Baduanjin training, as a simple daily pulmonary rehabilitation maneuver, could prevent the deterioration of pulmonary function in COPD patients and associated with improvement in exercise capacity and quality of life. CLINICALTRIAL The study protocol has been registered with the Clinical Trial Registry (NCT03892629).





Author(s):  
Maarten Stessel ◽  
Monique Wapenaar ◽  
Jasmina Huremovic ◽  
Elisabeth Bendstrup ◽  
Maria Molina ◽  
...  


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