Supine vs upright exercise in patients with hepatopulmonary syndrome and orthodeoxia: study protocol for a randomized controlled crossover trial

Abstract Background The hepatopulmonary syndrome (HPS) is a pulmonary complication of liver disease found in 10 to 32% of patients with cirrhosis and is characterized by intrapulmonary vascular dilatations and abnormal oxygenation. Liver transplantation is the only effective therapy for this disease. Patients with HPS have significant exercise limitations, impacting their quality of life and associated with poor liver transplant outcomes. Many patients with HPS exhibit orthodeoxia—an improvement in oxygenation in the supine compared to the upright position. We hypothesize that exercise capacity will be superior in the supine compared to the upright position in such patients. Methods We propose a randomized controlled crossover trial in patients with moderate HPS (PaO2 < 80 mmHg) and orthodeoxia (supine to upright PaO2 decrease > 4 mmHg) comparing the effect of supine vs upright position on exercise. Patients with pulmonary hypertension, FEV1/FVC ratio < 0.65, significant coronary artery disease, disorders preventing or contraindicating use of a cycle ergometer, and/or moderate or severe ascites will be excluded. Participants will be randomized to cycle ergometry in either the supine or upright position. After a short washout period (a minimum of 1 day to a maximum of 4 weeks), participants will crossover and perform an exercise in the alternate position. Exercise will be performed at a constant work rate of 70–85% of the predicted peak work rate until the “stopping time” is reached, defined by exhaustion, profound desaturation, or safety concerns (drop in systolic blood pressure or life-threatening arrhythmia). The primary outcome will be the difference in the stopping time between exercise positions, compared with a repeated measures analysis of variance method with a mixed effects model approach. The model will be adjusted for period effects. P < 0.05 will be considered statistically significant. Discussion HPS patients have hypoxemia leading to significant exercise limitations. If our study is positive, a supine exercise regimen could become a routine prescription for patients with HPS and orthodeoxia, enabling them to exercise more effectively. Future studies could explore the corresponding effects of a supine exercise training regimen on physiologic variables such as long-term exercise capacity, quality of life, dyspnea, and liver transplantation outcomes. Trial registration ClinicalTrials.gov Protocol Registration and Results System (PRS) NCT04004104. Registered on 1 July 2019

Download Full-text

Supine Versus Upright Exercise in Patients With Hepatopulmonary Syndrome and Orthodeoxia: Study Protocol for a Randomized Controlled Crossover Trial

10.21203/rs.3.rs-308658/v1 ◽

2021 ◽

Author(s):

Harsh Parikh ◽

Eric Lui ◽

Marie E Faughnan ◽

Abdul Al-Hesayen ◽

Stephanie Segovia ◽

...

Keyword(s):

Quality Of Life ◽

Liver Transplantation ◽

Exercise Capacity ◽

Stopping Time ◽

Hepatopulmonary Syndrome ◽

Upright Position ◽

Work Rate ◽

Exercise Limitation ◽

Randomized Controlled

Abstract Background: The hepatopulmonary syndrome (HPS) is a pulmonary complication of liver disease found in 10 to 32% of patients with cirrhosis and characterized by intrapulmonary vascular dilatations and abnormal oxygenation. Liver transplantation is the only effective therapy for this disease. Patients with HPS have significant exercise limitation, impacting their quality of life and associated with poor liver transplant outcomes. Many patients with HPS exhibit orthodeoxia – an improvement in oxygenation in the supine compared to the upright position. We hypothesize that exercise capacity will be superior in the supine compared to the upright position in such patients.Methods: We propose a randomized controlled cross-over trial in patients with HPS and orthodeoxia, comparing the effect of supine versus upright position on exercise. Participants will be randomized to cycle ergometry in either the supine or upright position, followed by a crossover to the alternate position after a minimum of 1 day to a maximum of 4 weeks. Exercise will be performed at a constant work rate of 70-85% of the predicted peak work rate until the “stopping time” is reached, defined by exhaustion, profound desaturation, or safety concerns (drop in systolic blood pressure or life-threatening arrhythmia). The primary outcome will be the difference in stopping time between exercise positions.Discussion: HPS patients have hypoxemia leading to significant exercise limitation. If our study is positive, a supine exercise regimen could become a routine prescription for patients with HPS and orthodeoxia, enabling them to exercise more effectively. Future studies could explore the corresponding effects of a supine exercise training regimen on physiologic variables such as long-term exercise capacity, quality of life, dyspnea, and liver transplantation outcomes. Trial registration: The ClinicalTrials.gov Protocol Registration and Results System (PRS): NCT04004104. Registered on 1st July 2019. https://clinicaltrials.gov/ct2/show/NCT04004104

Download Full-text

EXPRESS: The benefit of exercise-based rehabilitation programmes in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials

Pulmonary Circulation ◽

10.1177/20458940211007810 ◽

2021 ◽

pp. 204589402110078

Author(s):

Lu Yan ◽

Wence Shi ◽

Zhi-hong Liu ◽

Qin Luo ◽

Zhihui Zhao ◽

...

Keyword(s):

Quality Of Life ◽

Pulmonary Hypertension ◽

Randomized Controlled Trials ◽

Exercise Capacity ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

The Mean ◽

Quality Evidence

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I Â² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peakÂ oxygen uptakeÂ Â was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control groupÂ . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

Download Full-text

The risks and benefits of yoga for patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis

Clinical Rehabilitation ◽

10.1177/0269215519860551 ◽

2019 ◽

Vol 33 (12) ◽

pp. 1847-1862 ◽

Cited By ~ 2

Author(s):

Holger Cramer ◽

Heidemarie Haller ◽

Petra Klose ◽

Lesley Ward ◽

Vincent CH Chung ◽

...

Keyword(s):

Quality Of Life ◽

Pulmonary Function ◽

Exercise Capacity ◽

Meta Analysis ◽

Chronic Obstructive ◽

Controlled Trials ◽

Obstructive Pulmonary Disease ◽

Randomized Controlled ◽

Mean Differences

Objectives: To determine the effectiveness and safety of yoga interventions on disease symptoms, quality of life and function in patients diagnosed with chronic obstructive pulmonary disease (COPD). Data sources: Medline/PubMed, Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through 6 June 2019. Review methods: Randomized controlled trials assessing the effects of yoga on quality of life, dyspnea, exercise capacity, and pulmonary function (FEV1) in patients with COPD were included. Safety was defined as secondary outcome. Mean differences (MD) and standardized mean differences (SMD) with 95% confidence intervals (CIs) were computed. Risk of bias was assessed using the Cochrane tool. Results: Eleven randomized controlled trials with a total of 586 patients were included. Meta-analysis revealed evidence for effects of yoga compared to no treatment on quality of life on the COPD Assessment Test (MD = 3.81; 95% CI = 0.97 to 6.65; P = 0.009, I2 = 70%), exercise capacity assessed by the 6-minute walk test (MD = 25.53 m; 95% CI = 12.16 m to 38.90 m; P = 0.001, I2 = 0%), and pulmonary function assessed by FEV1 predicted (MD = 3.95%; 95% CI = 2.74% to 5.17%; P < 0.001, I2 = 0%). Only the effects on exercise capacity and pulmonary function were robust against methodological bias. Effects were only present in breathing-focused yoga interventions but not in interventions including yoga postures. Adverse events were reported infrequently. Conclusion: This meta-analysis found robust effects of yoga on exercise capacity and pulmonary function in patients with COPD. Yoga, specifically yoga breathing techniques, can be an effective adjunct intervention for patients with COPD. Yoga’s safety needs to be assessed in more depth in future studies.

Download Full-text

Effect of Yangyin Shuxin Decoction on Exercise Capacity in Patients with Heart Failure with Normal Ejection Fraction: Rationale and Design of a Randomized Controlled Trial

10.21203/rs.2.23369/v1 ◽

2020 ◽

Author(s):

Zhiqiang Zhao ◽

Xianliang Wang ◽

Shuai Wang ◽

Ruijuan Zhou ◽

Quan Su ◽

...

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Randomized Controlled Trial ◽

Exercise Capacity ◽

Standard Treatment ◽

Peak Velocity ◽

Controlled Trial ◽

Normal Ejection Fraction ◽

Randomized Controlled

Abstract Background The incidence of heart failure with normal ejection fraction (HFNEF) is increasing yearly, accounting for approximately half of all heart failure cases. Even after standardized treatment, the patient's prognosis is not good. Therefore, it is necessary to explore new treatment methods for HFNEF. Yangyin Shuxin Decoction, a traditional Chinese medicine prescription from our clinical experience in the treatment of HFNEF, has a potential cardioprotective effect. Preliminary clinical trials have shown that this prescription can improve the quality of life of HFNEF. This prompted us to use more objective indicators to further evaluate whether Yangyin Shuxin Decoction can improve the exercise capacity in HENEF patients. Methods This is a single-center parallel randomized controlled trial. The 64 patients who met the inclusion criteria were from the Cardiovascular Clinic. They will be randomly assigned to the treatment group (Yangying Shuxin Decoction combined with standard treatment) or the control group (standard treatment) according to the ratio of 1:1. The course of treatment will be 2 weeks. Both groups were interviewed at the following time points: of at enrollment (V1), and week 2 (V2), week 4 (V3), week 8 (V4), and week 12 (V5) after enrollment. The primary indicator is the peak oxygen consumption(Peak VO2) of the cardiopulmonary exercise test (CPET). Secondary indicators include CPET indicators such as anaerobic threshold oxygen consumption, carbon dioxide ventilation equivalent slope, echocardiographic indicators such as the ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity(E/e′), left atrial volume index (LAVI), left ventricular mass index (LVMI), the peak velocity of tricuspid regurgitation (TR), B-type natriuretic peptide (BNP), New York Heart Association (NYHA) cardiac function grading, and so on. These indicators will be used to evaluate the effect of Yangyin Shuxin Decoction on exercise capacity in patients with HFNEF. Discussion At present, it is unclear whether the exercise capacity can be maintained after long-term use of Yangyin Shuxin Decoction. In this study, we will evaluate whether Yangyin Shuxin Decoction can improve the exercise capacity and quality of life of patients with HFNEF. This will provide an objective basis for the therapeutic effect of traditional Chinese medicine on HFNEF.

Download Full-text