Rationale and Design of a Randomized Controlled Trial Evaluating Whole Muscle Exercise Training Effects in Outpatients with Pulmonary Arterial Hypertension (WHOLEi+12).

BACKGROUND AND AIMS: Physical exercise is an important component in the management of pulmonary artery hypertension (PAH). The aim of this randomized controlled trial (RCT) is to determine the effects of an 8-week intervention combining muscle resistance, aerobic and inspiratory pressure load exercises in PAH outpatients. METHODS: The RCT will be conducted from September 2015 to September 2016 following the recommendations of the Consolidated Standards of Reported Trials (CONSORT), with a total sample size of n ≥ 48 (≥24 participants/group). We will determine the effects of the intervention on: (i) skeletal-muscle power and mass (primary end points); and (ii) NT-proBNP, cardiopulmonary exercise testing variables (VO2peak, ventilatory equivalent for CO2 at the anaerobic threshold (VE/VCO2 at the AT), end-tidal pressure of CO2 at the anaerobic threshold (PETCO2 at the AT), 6-min walking distance (6MWD), maximal inspiratory pressure (PImax), health-related quality of life (HRQoL), objectively-assessed spontaneous levels of physical activity, and safety (secondary end points). CONCLUSIONS AND PERSPECTIVES: This trial will provide insight into biological mechanisms of the disease and indicate the potential benefits of exercise in PAH outpatients, particularly on muscle power.

Effects of Respiratory Muscle Training on Exercise Capacity, Quality of Life, and Respiratory and Pulmonary Function in People With Ischemic Heart Disease: Systematic Review and Meta-Analysis.

OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the effects of respiratory muscle training (RMT) on functional exercise capacity, health-related quality of life (HRQoL), respiratory muscle function, and pulmonary function in individuals with ischemic heart disease (IHD). METHODS: The MEDLINE, Web of Science, Scopus, PEDro, CINAHL, Science Direct, and CENTRAL electronic databases were searched in January 2023. Randomized controlled trials published in English, Spanish, or Portuguese that were conducted to determine the effect of RMT versus passive control and/or sham RMT on the target variables in individuals with IHD, irrespective of age or sex were included. Two reviewers performed the searches and extraction of the most relevant data. The quality and risk of bias for each included study were examined with the PEDro scale and Cochrane risk-of-bias tool. RESULTS: Thirteen studies (849 participants) were included. The meta-analysis showed a significant increase in peak oxygen consumption (mean difference [MD] = 2.18 mL·kg-1·min-1 [95% CI = 0.54 to 3.83]), inspiratory muscle strength (MD = 16.62 cm H2O [95% CI = 12.48 to 20.77]), inspiratory muscle endurance (standardized mean difference = 0.39 [95% CI = 0.19 to 0.60]), and expiratory muscle strength (MD = 14.52 cm H2O [95% CI = 5.51 to 23.53]). There were no benefits in 6-minute walking distance (MD = 37.57 m [95% CI = -36.34 to 111.48]), HRQoL (standardized mean difference = 0.22 [95% CI = -0.16 to 0.60]), pulmonary function (forced vital capacity; MD = 2.07% of predicted value [95% CI = -0.90 to 5.03], or forced expiratory volume at the first second (MD = -0.75% of predicted value [95% CI = -5.45 to 3.95]). CONCLUSION: This meta-analysis provided high- and moderate-quality evidence that inspiratory muscle training (IMT) improves inspiratory muscle strength and endurance, respectively; and very low-quality evidence for effects on peak oxygen consumption and expiratory muscle strength in individuals with IHD. No superior effects were found in the 6-minute walking test, HRQoL, or pulmonary function compared with the control group. IMPACT: The results shown in this systematic review with meta-analysis will provide clinicians a better understanding of the effects of IMT in people with IHD. IMT could be integrated into the cardiac rehabilitation management, although more research is needed.

Consensus on functional assessment of chronic pain in primary care: a Delphi study.

BACKGROUND: Chronic pain is a public health concern affecting 20-30% of the population of Western countries. Focus groups of people with persistent pain indicated that their overall physical function had deteriorated because of pain, therefore assessment of function should be an integral part of pain assessment. The objective of this study was to establish a consensus on assessment of function in chronic pain primary care patients and to evaluate the use of scales and clinical guidelines in clinical practice. METHODS: A Delphi study (CL4VE study) was carried out. A group of primary care physicians, were asked to rate how strongly they agreed/disagreed with the statements in: general functioning data, and functioning outcomes in chronic pain patients. RESULTS: Seventy-one primary care physicians were invited to participate. Of these, 69 completed Round 1 (98.5% response rate), and 68 completed Round 2 (97.1%). Under the predefined criterion, a high degree of agreement (91.4%) was observed, this was confirmed in 32 of 35 questions in the second round. Discrepancies were noted, firstly, because functioning was only linked to joint recovery; secondly, in the use of specific scales and questionnaires to measure functioning, and thirdly, that no scale of functioning is used in clinical practice due to complexity and lack of time for assessment. CONCLUSIONS: Physicians agreed on the need for a precise definition of the concept of patient functional impediment to facilitate homogeneous recognition, and for the development of simple and practical scales focused on patients with chronic pain and their needs.

Quality of life and functional outcomes with tapentadol prolonged release in chronic musculoskeletal pain: post hoc analysis.

Aims: To investigate quality of life (QOL) and functionality changes in chronic pain during tapentadol prolonged release (PR) treatment. Patients & methods: Post hoc analysis of data from three Phase III trials in patients with osteoarthritis knee pain or low back pain. QOL and functionality changes were assessed by SF-36 scores. Results: All SF-36 subdomain scores improved progressively to week 3 of tapentadol titration and were sustained during 12-week maintenance treatment. Improvements in SF-36 scores were similar between tapentadol dose groups (e.g., 200 to <300 mg vs ≥500 mg), with no greater effect from higher doses. QOL and functionality improvements were consistently greater with tapentadol PR than oxycodone controlled release. Conclusion: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.

Physical activity levels are low in patients with pulmonary hypertension.

BACKGROUND: Pulmonary hypertension (PH) leads to exercise capacity impairment, but limited data are available on the objective evaluation of physical activity (PA) levels in these patients. METHODS: We assessed PA levels using triaxial accelerometry in Spanish PH patients (n=75, 48±14 years, 65% female) and gender/age matched controls (n=107), and examined potential associations of meeting minimum international recommendations [moderate-vigorous PA (MVPA) ≥150 min/week] with survival predictors. RESULTS: With the exception of vigorous PA (with very low values in both groups), all accelerometry data showed significant differences between patients and controls, with lower PA levels and proportion of individuals meeting minimum PA guidelines, but higher inactivity time, in the former. Notably, the odds ratio (OR) of having a "low-risk" value of 6-minute walking distance (≥464 m) or ventilatory equivalent for carbon dioxide (≤39) was higher in patients following MVPA guidelines than in their less active peers [OR =4.3, 95% confidence interval (CI), 1.6-11.6, P=0.005, and OR =4.5, 95% CI, 0.9-21.1, P=0.054]. CONCLUSIONS: Daily PA is reduced in patients with PH, often to a level that may decrease their odds of survival. Efforts should be made to promote the implementation of healthy PA habits in this patient population.

Health Benefits of an Innovative Exercise Program for Mitochondrial Disorders.

PURPOSE: We determined the effects of an innovative 8-wk exercise intervention (aerobic, resistance, and inspiratory muscle training) for patients with mitochondrial disease. METHODS: Several end points were assessed in 12 patients (19-59 yr, 4 women) at pretraining, posttraining, and after 4-wk detraining: aerobic power, muscle strength/power and maximal inspiratory pressure (main end points), ability to perform activities of daily living, body composition, quality of life, and blood myokines (secondary end points). RESULTS: The program was safe, with patients' adherence being 94% ± 5%. A significant time effect was found for virtually all main end points (P ≤ 0.004), indicating a training improvement. Similar findings (P ≤ 0.003) were found for activities of daily living tests, total/trunk/leg lean mass, total fat mass, femoral fracture risk, and general health perception. No differences were found for blood myokines, except for an acute exertional increase in interleukin 8 at posttraining/detraining (P = 0.002) and in fatty acid binding protein 3 at detraining (P = 0.002). CONCLUSIONS: An intervention including novel exercises for mitochondrial disease patients (e.g., inspiratory muscle training) produced benefits in numerous indicators of physical capacity and induced a previously unreported shift toward a healthier body composition phenotype.

Benefits of skeletal-muscle exercise training in pulmonary arterial hypertension: The WHOLEi+12 trial.

BACKGROUND: Pulmonary arterial hypertension is often associated with skeletal-muscle weakness. The purpose of this randomized controlled trial was to determine the effects of an 8-week intervention combining muscle resistance, aerobic and inspiratory pressure-load exercises on upper/lower-body muscle power and other functional variables in patients with this disease. METHODS: Participants were allocated to a control (standard care) or intervention (exercise) group (n=20 each, 45±12 and 46±11years, 60% women and 10% patients with chronic thromboembolic pulmonary hypertension per group). The intervention included five, three and six supervised (inhospital) sessions/week of aerobic, resistance and inspiratory muscle training, respectively. The primary endpoint was peak muscle power during bench/leg press; secondary outcomes included N-terminal pro-brain natriuretic peptide levels, 6-min walking distance, five-repetition sit-to-stand test, maximal inspiratory pressure, cardiopulmonary exercise testing variables (e.g., peak oxygen uptake), health-related quality of life, physical activity levels, and safety. RESULTS: Adherence to training sessions averaged 94±0.5% (aerobic), 98±0.3% (resistance) and 91±1% (inspiratory training). Analysis of variance showed a significant interaction (group×time) effect for leg/bench press (P<0.001/P=0.002), with both tests showing an improvement in the exercise group (P<0.001) but not in controls (P>0.1). We found a significant interaction effect (P<0.001) for five-repetition sit-to-stand test, maximal inspiratory pressure and peak oxygen uptake (P<0.001), indicating a training-induced improvement. No major adverse event was noted due to exercise. CONCLUSIONS: An 8-week exercise intervention including aerobic, resistance and specific inspiratory muscle training is safe for patients with pulmonary arterial hypertension and yields significant improvements in muscle power and other functional variables.

Effects of an 8-month exercise intervention on physical capacity, NT-proBNP, physical activity levels and quality of life data in patients with pulmonary arterial hypertension by NYHA class.

This article provides descriptive detailed (pre and post) values of physical capacity variables, NT-proBNP, physical activity levels and quality of life in patients with pulmonary arterial hypertension (PH) (both, intervention and control group) by New York Heart Association (NYHA) class before and after an 8-month exercise intervention. The data are supplemental to our original Randomized Controlled Trial (RCT) entitled "Benefits of skeletal-muscle exercise training in pulmonary arterial hypertension: The WHOLEi+12 trial" (L. González-Saiz, C. Fiuza-Luces, F. Sanchis-Gomar, A. Santos-Lozano, C.A. Quezada-Loaiza, A. Flox-Camacho, D. Munguía-Izquierdo, I. Ara, A. Santalla, M. Morán, P. Sanz-Ayan, P. Escribano-Subías, A. Lucia A, 2017) [1].