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Effects of Aerobic Exercise as Add-On Treatment for Inpatients With Moderate to Severe Depression on Depression Severity, Sleep, Cognition, Psychological Well-Being, and Biomarkers: Study Protocol, Description of Study Population, and Manipulation Check.

ABSTRACT: Background: Aerobic exercise (AE) may be a non-pharmacological strategy to improve depression treatment and lessen the burden of somatic comorbidity of depression. Only few studies have examined the effect of AE as an add-on treatment for moderate to severe depression in an inpatient setting, and most studies have focused on depression severity and cardiovascular parameters. The purpose of the present article is to present the study protocol, to provide information about the assessed study population, and to perform a manipulation check in order to examine whether the intervention program was properly implemented. Methods: We conducted a randomized controlled trial in two centers comparing 6 weeks of AE to a placebo control intervention (stretching) as an add-on to standardized inpatient treatment of moderate to severe depression. Besides depression severity, several other psychological and biological variables were measured such as salivary cortisol, brain-derived neurotropic factor, cognitive tests, and polysomnography. To evaluate long-term effects of the intervention, we also scheduled a follow-up 6 months after completion of the study intervention. Results: Forty-five patients were randomized to either AE (n = 23) or the placebo intervention (n = 22); 36 patients completed the 6-week intervention. In the AE group, 65% completed all 18 training sessions. Patients who were less physically active prior to admission were less likely to complete the study. With regard to energy expenditure, mean kcal/kg/week was 16.4 kcal/kg/week (range: 13.8-17.7), coming close to the targeted dose of 17.5 kcal/kg/week. Conclusions: Overall, patients showed good adherence to the intervention protocol despite at least moderate depression severity. However, the dropout rate suggests that depressed inpatients may need special support to adhere to a structured exercise intervention program. This study will add evidence on the effects of AE as an add-on to inpatient treatment of moderate to severe depression. Besides antidepressant effects, potentially beneficial effects of AE on a broad array of further variables associated with depression will be evaluated. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02679053.

SUBMITTER: Imboden C

PROVIDER: S-EPMC6497035 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Effects of Aerobic Exercise as Add-On Treatment for Inpatients With Moderate to Severe Depression on Depression Severity, Sleep, Cognition, Psychological Well-Being, and Biomarkers: Study Protocol, Description of Study Population, and Manipulation Check.

Imboden Christian C Gerber Markus M Beck Johannes J Eckert Anne A Pühse Uwe U Holsboer-Trachsler Edith E Hatzinger Martin M

Frontiers in psychiatry 20190425

<b>Background:</b> Aerobic exercise (AE) may be a non-pharmacological strategy to improve depression treatment and lessen the burden of somatic comorbidity of depression. Only few studies have examined the effect of AE as an add-on treatment for moderate to severe depression in an inpatient setting, and most studies have focused on depression severity and cardiovascular parameters. The purpose of the present article is to present the study protocol, to provide information about the assessed stud ...[more]

PMID: 31073292

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Project description:IntroductionDepression is common, increasing among adolescents and carries risk of disability, lower educational achievements, cardiovascular disease, substance abuse, self-harm and suicide. The effects of evidence-based treatments with medication or psychotherapy are modest. Aerobic exercise is a promising intervention for adolescents with depression, but available studies are hampered by methodological shortcomings. This study aims to evaluate aerobic group exercise versus an active comparator of leisure group activities in adolescents from clinical services with mild-to-moderate depression.Methods and analysisThis study is a multicentre randomised controlled trial at four psychiatric clinics in Sweden. Participants (n=122) will be randomised 1:1 to group exercise delivered by exercise professionals and supported by mental health (MH) workers or leisure activities lead by the same MH workers for 1 hour three times a week for 12 weeks. Participants will be assessed at baseline, single blind after 13 weeks and 26 weeks and openly after 1 year. Participants randomised to the leisure group will be offered exercise in the open phase. The primary outcome is clinician-rated Children's Depression Rating Scale-Revised. Secondary outcomes are self-rated Quick Inventory of Depressive Symptomatology, self-rated functioning; clinician-rated improvement and functioning; objectively measured aerobic capacity, muscular strength, muscular endurance, body composition and presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples. Further outcomes are cost-effectiveness and adolescents', parents' and coaches' experiences of the interventions and an exploration of how the adolescents' health and lifestyle are influenced by the interventions through qualitative interviews.Ethics and disseminationThe study is approved by the Swedish Ethical Review Authority (Ref. 2021-05307-01). Informed consent in writing will be provided from patients and parents of participants below 15 years of age. The results of this study will be communicated to the included participants and healthcare providers and also submitted for publication in peer-reviewed journals.Trial registration numberNCT05076214.

Project description:BackgroundPatients with major depression disorder presents increased rates of cognitive decline, reduced hippocampal volume, poor sleep quality, hypertension, obesity, suicidal ideation and behavior, and decreased functionality. Although continuous aerobic exercise (CAE) improves some of the aforementioned symptoms, comorbidities, and conditions, recent studies have suggested that performing aerobic exercise with motor complexity (AEMC) may be more beneficial for cognitive decline, hippocampal volume, and functionality. Therefore, this randomized controlled trial will compare the effects of CAE and AEMC on depression score, cognitive function, hippocampal volume, brain-derived neurotrophic factor expression, sleep parameters, cardiovascular risk parameters, suicidal behavior, functionality, and treatment costs in patients with depression.Methods/designSeventy-five medicated patients with depression will be recruited from a Basic Healthcare Unit to participate in this prospective, parallel group, single blinded, superiority, randomized controlled trial. Patients with depression according to DSM-V criteria will be balanced and randomly assigned (based on depression scores and number of depressive episodes) to a non-exercising control (C), CAE, and AEMC groups. The CAE and AEMC groups will exercise for 60 min, twice a week for 24 weeks (on non-consecutive days). Exercise intensity will be maintained between 12 and 14 points of the rating of perceived exertion scale (~?70-80% of the maximum heart rate). The CAE group will perform a continuous aerobic exercise while the AEMC group will perform exercises with progressively increased motor complexity. Blinded raters will assess patients before and after the intervention period. The primary outcome measure will be the change in depression score measured by the Montgomery-Asberg Depression Rating Scale. Secondary outcomes will include measures of cognitive function, hippocampal volume, brain-derived neurotrophic factor expression, sleep parameters, cardiovascular risk parameters, suicidal behavior, functionality, and treatment costs.DiscussionThis study was selected in the call of public policy programs for the Brazilian Unified National Health System - "PPSUS 2015". To our knowledge, this is the first pragmatic trial to test the effect of adding AEMC to the pharmacological treatment of patients with depression and to evaluate the possible reductions in depression symptoms and healthcare costs.Trial registrationBrazilian Clinical Trials Registry (ReBec) - RBR-9zgxzd - Registered on 4 Jan. 2017.

Dataset Information

Effects of Aerobic Exercise as Add-On Treatment for Inpatients With Moderate to Severe Depression on Depression Severity, Sleep, Cognition, Psychological Well-Being, and Biomarkers: Study Protocol, Description of Study Population, and Manipulation Check.

Publications

Effects of Aerobic Exercise as Add-On Treatment for Inpatients With Moderate to Severe Depression on Depression Severity, Sleep, Cognition, Psychological Well-Being, and Biomarkers: Study Protocol, Description of Study Population, and Manipulation Check.

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