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Aerobic endurance training to improve cognition and enhance recovery in schizophrenia: design and methodology of a multicenter randomized controlled trial.

ABSTRACT: Even today, patients with schizophrenia often have an unfavorable outcome. Negative symptoms and cognitive deficits are common features in many patients and prevent recovery. In recent years, aerobic endurance training has emerged as a therapeutic approach with positive effects on several domains of patients' health. However, appropriately sized, multicenter randomized controlled trials that would allow better generalization of results are lacking. The exercise study presented here is a multicenter, rater-blind, two-armed, parallel-group randomized clinical trial in patients with clinically stable schizophrenia being conducted at five German tertiary hospitals. The intervention group performs aerobic endurance training on bicycle ergometers three times per week for 40-50 min/session (depending on the intervention week) for a total of 26 weeks, and the control group performs balance and tone training for the same amount of time. Participants are subsequently followed up for 26 weeks. The primary endpoint is all-cause discontinuation; secondary endpoints include psychopathology, cognition, daily functioning, cardiovascular risk factors, and explorative biological measures regarding the underlying mechanisms of exercise. A total of 180 patients will be randomized. With currently 162 randomized participants, our study is the largest trial to date to investigate endurance training in patients with schizophrenia. We hypothesize that aerobic endurance training has beneficial effects on patients' mental and physical health, leading to lower treatment discontinuation rates and improving disease outcomes. The study results will provide a basis for recommending exercise interventions as an add-on therapy in patients with schizophrenia.The study is registered in the International Clinical Trials Database (ClinicalTrials.gov identifier [NCT number]: NCT03466112) and in the German Clinical Trials Register (DRKS-ID: DRKS00009804).

SUBMITTER: Maurus I

PROVIDER: S-EPMC8257533 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:A low maximal oxygen consumption (VO2max) is a strong risk factor for premature mortality. Supervised endurance exercise training increases VO2max with a very wide range of effectiveness in humans. Discovering the DNA variants that contribute to this heterogeneity typically requires substantial sample sizes. In the present study, we first use RNA expression profiling to produce a molecular classifier that predicts VO2max training response. We then hypothesized that the classifier genes would harbor DNA variants that contributed to the heterogeneous VO2max response. Two independent preintervention RNA expression data sets were generated (n=41 gene chips) from subjects that underwent supervised endurance training: one identified and the second blindly validated an RNA expression signature that predicted change in VO2max ("predictor" genes). The HERITAGE Family Study (n=473) was used for genotyping. We discovered a 29-RNA signature that predicted VO2max training response on a continuous scale; these genes contained approximately 6 new single-nucleotide polymorphisms associated with gains in VO2max in the HERITAGE Family Study. Three of four novel candidate genes from the HERITAGE Family Study were confirmed as RNA predictor genes (i.e., "reciprocal" RNA validation of a quantitative trait locus genotype), enhancing the performance of the 29-RNA-based predictor. Notably, RNA abundance for the predictor genes was unchanged by exercise training, supporting the idea that expression was preset by genetic variation. Regression analysis yielded a model where 11 single-nucleotide polymorphisms explained 23% of the variance in gains in VO2max, corresponding to approximately 50% of the estimated genetic variance for VO2max. In conclusion, combining RNA profiling with single-gene DNA marker association analysis yields a strongly validated molecular predictor with meaningful explanatory power. VO2max responses to endurance training can be predicted by measuring a approximately 30-gene RNA expression signature in muscle prior to training. The general approach taken could accelerate the discovery of genetic biomarkers, sufficiently discrete for diagnostic purposes, for a range of physiological and pharmacological phenotypes in humans.

Project description:Respiratory/inspiratory muscle training (RMT/IMT) has been proposed to improve the endurance performance of athletes in normoxia. In recent years, due to the increased use of hypoxic training method among athletes, the RMT applicability has also been tested as a method to minimize adverse effects since hyperventilation may cause respiratory muscle fatigue during prolonged exercise in hypoxia. We performed a review in order to determine factors potentially affecting the change in endurance performance in hypoxia after RMT in healthy subjects. A comprehensive search was done in the electronic databases MEDLINE and Google Scholar including keywords: "RMT/IMT," and/or "endurance performance," and/or "altitude" and/or "hypoxia." Seven appropriate studies were found until April 2018. Analysis of the studies showed that two RMT methods were used in the protocols: respiratory muscle endurance (RME) (isocapnic hyperpnea: commonly 10-30', 3-5 d/week) in three of the seven studies, and respiratory muscle strength (RMS) (Powerbreathe device: commonly 2 × 30 reps at 50% MIP (maximal inspiratory pressure), 5-7 d/week) in the remaining four studies. The duration of the protocols ranged from 4 to 8 weeks, and it was found in synthesis that during exercise in hypoxia, RMT promoted (1) reduced respiratory muscle fatigue, (2) delayed respiratory muscle metaboreflex activation, (3) better maintenance of SaO2 and blood flow to locomotor muscles. In general, no increases of maximal oxygen uptake (VO2max) were described. Ventilatory function improvements (maximal inspiratory pressure) achieved by using RMT fostered the capacity to adapt to hypoxia and minimized the impact of respiratory stress during the acclimatization stage in comparison with placebo/sham. In conclusion, RMT was found to elicit general positive effects mainly on respiratory efficiency and breathing patterns, lower dyspneic perceptions and improved physical performance in conditions of hypoxia. Thus, this method is recommended to be used as a pre-exposure tool for strengthening respiratory muscles and minimizing the adverse effects caused by hypoxia related hyperventilation. Future studies will assess these effects in elite athletes.

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Aerobic endurance training to improve cognition and enhance recovery in schizophrenia: design and methodology of a multicenter randomized controlled trial.

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