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Effects of high-intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial.

ABSTRACT: The focus in recent years on physical inactivity and metabolic disturbances in individuals with schizophrenia raises the question of potential effects of physical activity. Physical activity has shown beneficial effects on cognition in healthy older individuals as well as on symptom severity in depression. However, opinions diverge regarding whether aerobic high-intensity interval training reduces cognition and key symptoms in schizophrenia. The main objective for the trial is to investigate the potential effects of aerobic high-intensity interval training on neurocognitive function and mental symptoms in outpatients with schizophrenia.The trial is designed as a randomized controlled, observer-blinded clinical trial. Patients are randomized to 1 of 2 treatment arms with 12-week duration: aerobic high-intensity interval training or computer gaming skills training. All participants also receive treatment as usual. Primary outcome measure is neurocognitive function. Secondary outcome measures will be positive and negative symptoms, wellbeing, tobacco-smoking patterns and physiological/metabolic parameters. Patient recruitment takes place in catchment area-based outpatient clinics.ClinicalTrials.gov NCT02205684 . Registered 29 July 2014.

SUBMITTER: Engh JA

PROVIDER: S-EPMC4672547 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Effects of high-intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial.

Engh John A JA Andersen Eivind E Holmen Tom L TL Martinsen Egil W EW Mordal Jon J Morken Gunnar G Egeland Jens J

Trials 20151208

<h4>Background</h4>The focus in recent years on physical inactivity and metabolic disturbances in individuals with schizophrenia raises the question of potential effects of physical activity. Physical activity has shown beneficial effects on cognition in healthy older individuals as well as on symptom severity in depression. However, opinions diverge regarding whether aerobic high-intensity interval training reduces cognition and key symptoms in schizophrenia. The main objective for the trial is ...[more]

PMID: 26646670

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Project description:BackgroundHip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Most evidence is based on muscle-strengthening exercise, but aerobic physical activity has potential to enhance clinical benefits. The primary aim of this study is to test the hypothesis that adding aerobic physical activity to a muscle strengthening exercise leads to significantly greater reduction in hip pain and improvements in physical function, compared to a lower-limb muscle strengthening exercise program alone at 3 months.MethodsThis is a superiority, 2-group, parallel randomised controlled trial including 196 people with symptomatic hip OA from the community. Following baseline assessment, participants are randomly allocated to receive either i) aerobic physical activity and muscle strengthening exercise or; ii) muscle strengthening exercise only. Participants in both groups receive 9 consultations with a physiotherapist over 3 months. Both groups receive a progressive muscle strengthening exercise program in addition to advice about OA management. The aerobic physical activity plan includes a prescription of moderate intensity aerobic physical activity with a goal of attaining 150 min per week. Primary outcomes are self-reported hip pain assessed on an 11-point numeric rating scale (0 = 'no pain' and 10 = 'worst pain possible') and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale) at 3 months. Secondary outcomes include other measures of self-reported pain (assessed at 0, 3, 9 months), self-reported physical function (assessed at 0, 3, 9 months), performance-based physical function (assessed at 0, 3 months), joint stiffness (assessed at 0, 3, 9 months), quality of life (assessed at 0, 3, 9 months), muscle strength (assessed at 0, 3 months), and cardiorespiratory fitness (assessed at 0, 3 months). Other measures include adverse events, co-interventions, and adherence. Measures of body composition, serum inflammatory biomarkers, quantitative sensory measures, anxiety, depression, fear of movement and self-efficacy are included to explore causal mechanisms.DiscussionFindings will assist to provide an evidence-based recommendation regarding the additional effect of aerobic physical activity to lower-limb muscle strengthening on hip OA pain and physical function.Trial registrationAustralian New Zealand Clinical Trials Registry reference: ACTRN 12619001297112. Registered 20th September 2019.

Project description:BackgroundSince the introduction of antiretroviral therapy (ART), the incidence of HIV-associated dementia has drastically fallen. Despite using ART, people living with HIV continue to experience less severe but limiting forms of HIV-associated neurocognitive disorder (HAND). People living with HIV who are on ART and experiencing symptoms of HAND may benefit from aerobic exercise.ObjectiveThis protocol describes a randomized controlled trial designed to determine the effects of a 12-week aerobic exercise program on HAND in Southeastern Nigeria.MethodsAt least 68 patients diagnosed with HAND will be randomly placed into either an aerobic exercise group or control group. Patients in the aerobic exercise group will perform a moderate intensity workout on a stationary bicycle ergometer, 3 times a week for 12 weeks. We will measure the primary outcomes including neurocognitive performance, prevalence of HAND, viral load, and CD4 count. We will evaluate postexercise neurocognitive performance using reliable neuropsychological tests relevant to people living with HIV, in line with the Frascati criteria. We will assess secondary outcomes such as quality of life, activity limitation, and social participation using the World Health Organization Quality of Life (WHOQOL)-Brief, and the Oxford Participation and Activities questionnaire. We will use exploratory statistics to test the data for normality and homogeneity. We will analyze the effect of the exercise program on HAND using relative risk (RR) and absolute risk reduction (number needed to treat). Analysis of covariance will be run to estimate the effect of exercise on quality of life and activity and participation level.ResultsThis funded trial was approved by the Institutional Review Board in May 2020. The protocol was approved on June 15, 2020. Enrollment commenced in January 2021 and was completed in May 2021. Over 60% of the participants were recruited at the time of first submission to JMIR Mental Health. Data curation is still ongoing; hence, data analysis is yet to be executed. Study outcomes are expected to be published in March 2022.ConclusionsThis is a protocol for a randomized controlled trial that aims to evaluate the effect of a 12-week aerobic exercise program on HAND in Southeastern Nigeria.Trial registrationPan African Clinical Trials Registry PACTR202009483415745; https://tinyurl.com/2p97zpu9.International registered report identifier (irrid)PRR1-10.2196/29230.

Dataset Information

Effects of high-intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial.

Publications

Effects of high-intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial.

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