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      Effects of an exercise and sport intervention among refugees living in a Greek refugee camp on mental health, physical fitness and cardiovascular risk markers: study protocol for the SALEEM pragmatic randomized controlled trial

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          Abstract

          Background

          Due to ongoing political and social conflicts, the number of international refugees has been increasing. Refugees are exposed to severe mental and physical strain, as well as traumatic experiences during their flight. Therefore, the risk of psychiatric disorders is markedly increased among international refugees. International organizations have criticized the lack of early interventions as a key problem, because untreated mental disorders are often difficult to cure at a later stage. Today, exercise and sport have been successfully employed to treat a wide range of psychiatric disorders. With patients with post-traumatic stress disorders (PTSD), very limited empirical evidence exists, and studies carried out with international refugees are nearly non-existent.

          Methods

          We intend to implement a pragmatic randomized controlled trial (RCT) with an exercise and sport intervention group ( n = 68, 50% women) and a wait-list control group ( n = 68, 50% women) in the Koutsochero refugee camp, located close to the city of Larissa (Greece). During the RCT, exercise and sport will be offered five times per week (60 min/session) for 10 weeks. Participants will be asked to participate in at least two sessions per week. The programme is developed according to the participants’ needs and preferences and they will be able to choose between a range of activities. PTSD symptoms will serve as primary outcome, and several secondary outcomes will be assessed. Qualitative data collection methods will be used to gain a more in-depth appraisal of the participants’ perception of the intervention programme. In the second year of study, the programme will be opened to all camp residents. A strategy will be developed how the programme can be continued after the end of the funding period, and how the programme can be scaled up beyond the borders of the Koutsochero camp.

          Discussion

          By moving towards the primary prevention of chronic physical conditions and psychiatric disorders, a relevant contribution can be done to enhance the quality and quantity of life of refugee camp residents in Greece. Our findings may also strengthen the evidence for exercise as medicine as a holistic care option in refugee camps, by helping camp residents to adopt and maintain a physically active lifestyle.

          Trial registration

          The study was registered prospectively on the 8 February 2021 with ISRCTN https://www.isrctn.com/ISRCTN16291983

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          Most cited references91

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            A Global Measure of Perceived Stress

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              Executive Functions

              Executive functions (EFs) make possible mentally playing with ideas; taking the time to think before acting; meeting novel, unanticipated challenges; resisting temptations; and staying focused. Core EFs are inhibition [response inhibition (self-control—resisting temptations and resisting acting impulsively) and interference control (selective attention and cognitive inhibition)], working memory, and cognitive flexibility (including creatively thinking “outside the box,” seeing anything from different perspectives, and quickly and flexibly adapting to changed circumstances). The developmental progression and representative measures of each are discussed. Controversies are addressed (e.g., the relation between EFs and fluid intelligence, self-regulation, executive attention, and effortful control, and the relation between working memory and inhibition and attention). The importance of social, emotional, and physical health for cognitive health is discussed because stress, lack of sleep, loneliness, or lack of exercise each impair EFs. That EFs are trainable and can be improved with practice is addressed, including diverse methods tried thus far.
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                Author and article information

                Contributors
                markus.gerber@unibas.ch
                flora.colledge@unibas.ch
                dominique.dequervain@unibas.ch
                Konstantina.filippou@pe.uth.gr
                elsainkerihavas@gmail.com
                florian.knappe@unibas.ch
                sebastian.ludyga@unibas.ch
                marianne.meier@izfg.unibe.ch
                iomorres@pe.uth.gr
                panagos.alexandros3@gmail.com
                uwe.puehse@unibas.ch
                karim.ramadan01@lau.edu
                herald.seelig@unibas.ch
                theodorakis@pe.uth.gr
                ahatzi@pe.uth.gr
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                21 November 2021
                21 November 2021
                2021
                : 22
                : 827
                Affiliations
                [1 ]GRID grid.6612.3, ISNI 0000 0004 1937 0642, Department of Sport, Exercise and Health, , University of Basel, ; Grosse Allee 6, CH-4052 Basel, Switzerland
                [2 ]GRID grid.6612.3, ISNI 0000 0004 1937 0642, Division of Cognitive Neuroscience, , University of Basel, ; Basel, Switzerland
                [3 ]GRID grid.410558.d, ISNI 0000 0001 0035 6670, Department of Physical Education and Sport Sciences, , University of Thessaly, ; Volos, Greece
                [4 ]GRID grid.5734.5, ISNI 0000 0001 0726 5157, Interdisciplinary Center for Gender Studies, , University of Bern, ; Bern, Switzerland
                [5 ]GRID grid.412004.3, ISNI 0000 0004 0478 9977, Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, , University Hospital Zurich, ; Zurich, Switzerland
                Author information
                http://orcid.org/0000-0001-6140-8948
                Article
                5808
                10.1186/s13063-021-05808-2
                8607641
                34802451
                7916cbd6-ba8b-4dee-9ec7-43cd6406b4ad
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 11 May 2021
                : 8 November 2021
                Funding
                Funded by: Swiss Network for International Studies (SNIS)
                Award ID: n.a.
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2021

                Medicine
                asylum seekers,cardiovascular risk,exercise,fitness,greece,mental health,physical activity,post-traumatic stress disorders,randomized controlled trial,refugees,sport

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