Effects of an exercise and sport intervention among refugees living in a Greek refugee camp on mental health, physical fitness and cardiovascular risk markers

Plain English Summary

Background and study aims
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. As a consequence, the risk of psychiatric disorders is markedly increased among international refugees with particularities based on gender. 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 PTSD patients, however, very limited empirical evidence exists, and studies carried out with international refugees are nearly non-existent.

In 2017, the study team implemented a pilot study in a Greek refugee camp to investigate the potential benefits of exercise and sport on refugees’ mental health and fitness. Therefore, the main purpose of this study is to invetsigate the effects of a sport and exercise intervention among refugees living in a Greek refugee camp on PTSD symptoms in a larger clinical trial. There is also a long term aim to develop a strategy to continue the exercise and sport program after the funding of the Swiss Network for International Studies (SNIS) comes to an end, and to scale up the program beyond the borders of the Koutsochero camp.

Who can participate?
People aged 16-59 years and living in the Koutsochero refugee camp who provide informed consent to participate will be eligible

What does the study involve?
The proposed study will take place in the Koutsochero refugee camp, located close to the city of Larissa (Greece). Participants in the study will be randomly allocated to either begin the exercise and sport program immediately or will be added to a wait-list to begin the program at a later date. Participants will be assessed three times, first, before beginning the program, then immediately at the end of the program (after 3 months), and then after a further 3 months for a final follow-up (after 6 months from the beginning of the program). In the second year of study, the program will be opened to all camp residents. Exercise and sport will be offered five times per week for three months, with sessions lasting 60 min. Participants will participate in at least two sessions per week. The program is developed according to the participants’ needs and preferences and they will be able to choose between a range of activities.

What are the possible benefits and risks of participating?
Personal benefits for participants are that they can participate in a 3-month structured exercise and sport program at least 2 times per week for 60 min. They will also have the possibility to continue their participation after the end of the trial (at least until February 2023). Regular participation in physical activity is recommended by the World Health Organization to maintain good health. It is hoped that the study will provide important information regarding the potential of regular exercise and sport participation to improve refugees’ health.

Risks for capillary blood sampling are minimal and present a frequently used procedure. Nevertheless, finger prick might be a slightly uncomfortable procedure. Participants will fill in a Physical Activity Readiness questionnaire before study enrolment to ensure that they will be suitable to take part in the exercise program. In the case of contra-indications, consultation with a medical doctor will be held.

Where is the study run from?
The project is organized as a cooperation between the universities of Basel, Zürich, and Bern (Switzerland) and the University of Thessaly (Greece) and will be closely cooperating with the Ministry of Migration and Asylum (Greece), the municipality of Larissa (Greece), the Danish Refugee Council (Denmark), and other locally active NGOs.

When is the study starting and how long is it expected to run for?
From January 2020 to February 2023

Who is funding the study?
The Swiss Network for International Studies (Switzerland)

Who is the main contact?
1. Prof. Dr. Markus Gerber (Switzerland)
Markus.gerber@unibas.ch
2. Prof. Dr. Antonis Hatzigeorgiadis (Greece)
ahatzigeorgiadis@yahoo.com

Study website

Type

Scientific

Contact name

Prof Markus Gerber

ORCID ID

https://orcid.org/0000-0001-6140-8948

Contact details

Department of Sport
Exercise and Health
University of Basel
St. Jakob-Turm
Birsstrasse 320B
Basel
4052
Switzerland
+41612074783
markus.gerber@unibas.ch

Type

Scientific

Contact name

Dr Antonis Hatzigeorgiadis

ORCID ID

http://orcid.org/0000-0001-7062-479X

Contact details

Department of Physical Education and Sport Science
University of Thessaly
Karyes
Trikala
42100
Greece
+302431047009
ahatzi@uth.gr

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Scientific title

Effects of an exercise and sport intervention among refugees living in a Greek refugee camp on mental health, physical fitness and cardiovascular risk markers (REMEX)

Acronym

SALEEM

Study hypothesis

The main purpose of the present study is to examine with a randomized controlled trial (RCT) the effects of a sport and exercise intervention among refugees living in a Greek refugee camp on PTSD symptoms (primary outcome). Based on an initial pilot study, our main hypothesis is that a sport and exercise intervention has a positive influence on both the primary and secondary outcomes.

Ethics approval(s)

Approved 26/11/2020, Ethikkommission Nordwest- und Zentralschweiz (EKNZ) (Hebelstrasse 53, 4056 Basel, Switzerland; +41 (0)61 268 13 50; eknz@bs.ch), ref: AO_2020_00036

Study design

Single-blind randomized wait-list controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study type

Prevention

Patient information sheet

See additional files

Condition

Prevention of post-traumatic stress disorder symptoms among refugees living in a Greek refugee camp

Intervention

The study is designed as a randomized controlled trial (RCT) with an intervention group (IG, who will participate in the exercise and sport activities) and a wait-list control group (WLCG), with a 1:1 allocation ratio between the IC and WLCG, and with concealed allocation to groups. To ensure allocation concealment, allocation to groups will be done randomly by a computer-generated code after the baseline assessment has taken place. In order to reduce random differences between the two groups, we will use the "OxMaR" software (Oxford Minimization and Randomization), taking into account the following stratification variables: gender, age, time fleeing, and PTSD symptom severity.

Exercise and sport activities will be offered five times per week (60 min/session) for three months. Separate programs will be offered for men and women. Moreover, cultural particularities of the target population will be considered during program development. Participants are asked to participate in at least two sessions per week (but encouraged to do more). Participants can choose between a range of activities. Based on experience from a pilot study where 95% were satisfied or very satisfied, activities for males could include weight and endurance training, football, volleyball, or other activities depending on the needs and preferences of the participants. The program for female participants will also consider their needs and preferences. Thus, we will carry out individual interviews and organize focus group discussions in order to develop appropriate programs for male and female participants. Due to possible language barriers or inter-cultural difficulties due to multi-ethnic background of refugees, it is important that the activities are tailor-made, in particular, simple, acceptable, pleasant, and easy to understand and apply to meet individual, gender, age, ethnic/cultural-specific needs and preferences in the real-life (pragmatic) setting of a refugee camp with limited exercise/sport facilities. Tailor-made interventions are highlighted by international physical activity guidelines for people with mental health problems and proved to provide mental health benefits in real-life settings.

After the 3 month program, all participants will be assessed, and then followed up again after 6 months. In the second year of the study, the program will be made available to the wait-list control group.

Intervention type

Behavioural

Primary outcome measure

1. Post-traumatic stress disorder symptoms measured using a self-report questionnaire at baseline, 3, 6, and 9 months

Secondary outcome measures

1. Perceived stress measured using self-report questionnaires at baseline, 3, 6, and 9 months
2. Depressive symptoms measured using self-report questionnaires at baseline, 3, 6, and 9 months
3. Anxiety symptoms measured using self-report questionnaires at baseline, 3, 6, and 9 months
4. Insomnia symptoms measured using self-report questionnaires at baseline, 3, 6, and 9 months
5. Health-related quality of life measured using self-report questionnaires at baseline, 3, 6, and 9 months
6. Pain measured using a visual analogue scale at baseline, 3, 6, and 9 months
7. Perceived fitness measured using self-report questionnaires at baseline, 3, 6, and 9 months
8. Cardiorespiratory fitness measured using a bicycle ergometer test at baseline, 3, 6, and 9 months
9. Hand grip strength measured using the hand grip strength test at baseline, 3, 6, and 9 months
10. Physical activity measured using 7-day accelerometry at baseline, 3, 6, and 9 months
11. Cognitive function measured using computerized tests at baseline, 3, 6, and 9 months
12. Cardiovascular risk markers:
12.1. Body weight and height measured using a digital weighing scale and a stadiometer at baseline, 3, 6, and 9 months
12.2. Body composition measured using a bioelectrical impedance analysis at baseline, 3, 6, and 9 months
12.3. Waist circumference measured using a flexible tape at baseline, 3, 6, and 9 months
12.4. Systolic and diastolic blood pressure measured using a digital blood pressure monitor at baseline, 3, 6, and 9 months
12.5. Anaemia measured using a HemoCue® Hb 301 system at baseline, 3, 6, and 9 months
12.6. Blood lipids, blood glucose, inflammatory cytokines measured using an Alere point-of-care (PAC) analyser at baseline, 3, 6, and 9 months
13. Participants socio-demographic background and potential confounders (age, nationality, religious background, marital status, number of children, educational background, time fleeing, time in camp, physical activity level during the past week, and PTSD symptoms) are assessed using an interview format before the baseline data assessment

Overall study start date

01/01/2020

Overall study end date

28/02/2023

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Informed consent given
2. Aged 16-59 years
3. Living in the selected refugee camp

Participant type(s)

Mixed

Age group

Adult

Lower age limit

16 Years

Upper age limit

59 Years

Sex

Both

Target number of participants

136

Total final enrolment

143

Participant exclusion criteria

1. Any contra-indications for moderate-intensity physical activity (based on the Physical Activity Readiness Questionnaire)
2. Unable to exercise at least two times per week for 60 min at moderate intensity

Recruitment start date

01/03/2021

Recruitment end date

31/08/2021

Countries of recruitment

Greece

Study participating centre

Koutsochero refugee camp
Koutsochero
Larissa
415 00
Greece

Organisation

University of Basel

Sponsor details

Department of Sport
Exercise and Health
St. Jakob-Turm
Birsstrasse 320B
Basel
4052
Switzerland
+41 612074783
sekretariat-dsbg@unibas.ch

Sponsor type

University/education

Website

https://dsbg.unibas.ch/de/home/

ROR

https://ror.org/02s6k3f65

Funder type

Government

Funder name

Swiss Network for International Studies

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Publication plan
The trial steering committee will coordinate the international dissemination of the study results through presentations at national and international conferences and publications in peer-reviewed literature. In order to achieve the greatest possible reach, all publications will be “open access”.

Dissemination plan
1. Information for key stakeholders. During the program development phase, we will closely collaborate with a variety of partner organizations, in order to maximise their commitment and ensure that they feel a strong sense of investment in the project. At the end of the study, the results will be communicated to the respective health, education and administrative authorities in Greece and in Switzerland, as well as the management of other refugee camps in Greece. Video footage will be collected during the entire course of the project in order to document and promote our intervention measures. A short film trailer will be helpful in summarizing the main results and lessons that should be considered in the future.
2. Project homepage. At the beginning of the project, we will create a project homepage to inform the public as soon as possible about our planned activities as efficiently as possible. This homepage will present an overview of the randomized controlled trial, the project team and partners, and well as funding organizations. The project homepage will also serve as a platform to make the intervention material publicly available.
3. Social media. During the course of the project, Facebook and Twitter accounts will be created (and linked to the project homepage) to communicate and promote the activities of the project, and to encourage interaction between all involved parties; including refugees, sport coaches, and associates of the program.
4. Sustainability. Participants of the intervention and wait-list control groups will have the opportunity to continue their participation in the exercise and sport program once the official intervention has come to an end. Based on qualitative interviews with the refugees and people involved in the implementation of the program, we will strive to improve the intervention material on a regular basis, and develop a program that is highly attractive to the participants (including both male and female refugees). Since we will open the program for all camp residents in the second year of the study, we will receive immediate feedback regarding the acceptability and perceived attractiveness of our program. We will also develop a strategy for the continuation of the exercise and sport program can be continued after the SNIS funding comes to an end, and for scaling-up of the program beyond the borders of the Koutsochero refugee camp.
5. Training seminars. During the second year of the project, our university teams will be delivering sport and physical activity programs to all refugees wishing to participate. During the same period, seminars regarding the implementation of sport and physical activity programs for refugees will be offered to interested parties. In particular, seminars will be delivered to sport students from the universities of Thessaly and Basel, coaches of different sports, fitness instructors, and employees working in the refugee camp, such as health professionals, social workers, and care-takers. Furthermore, the seminars will be adapted so that they can be offered to refugees who can speak Greek or English, and who could eventually lead or facilitate sport and physical activity participation in the camp. In addition, internships positions for the refugee camp can be offered by the universities, to further promote the sustainability of the project.
6. Conference presentations. A series of presentations will be delivered at conferences in Switzerland and Greece, and also internationally. In particular, a symposium will be organized in the 16th European Congress of Sport and Exercise Psychology that takes place the summer of 2022 in Padova, Italy.
7. Cooperation with professional associations: Several professional associations have shown great interest in the planned study. Some of them have offered to post a short description of our trial on their homepage, and have a short abstract published in their newsletters or in their internal publication outlets.

Intention to publish date

30/09/2023

Individual participant data (IPD) sharing plan

In line with the guidelines and open access policies of nationally and internationally recognized foundations and institutions, the published data from our project will be stored in a publically available repository, at https://fairsharing.org (individual participant data that underlie the results reported in an article, after deidentification; immediately following publication; anyone who wishes to access the data; for any purpose; data are available indefinitely).

IPD sharing plan summary

Stored in publicly available repository

Study outputs

• ISRCTN16291983_PIS_v2_24Nov2020.pdf uploaded 08/02/2021