Effects of an exercise and sport intervention among refugees living in a Greek refugee camp on mental health, physical fitness and cardiovascular risk markers
| ISRCTN | ISRCTN16291983 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16291983 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Basel |
| Funder | Swiss Network for International Studies |
- Submission date
- 15/12/2020
- Registration date
- 08/02/2021
- Last edited
- 16/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Department of Sport, Exercise and Health
University of Basel
St. Jakob-Turm
Birsstrasse 320B
Basel
4052
Switzerland
 ORCID ID |
0000-0001-6140-8948 |
|---|---|
| Phone | +41612074783 |
| markus.gerber@unibas.ch |
Scientific
Department of Physical Education and Sport Science
University of Thessaly
Karyes
Trikala
42100
Greece
| ORCID ID |
0000-0001-7062-479X |
|---|---|
| Phone | +302431047009 |
| ahatzi@uth.gr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomized wait-list controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN16291983_PIS_v2_24Nov2020.pdf |
| 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) |
| Study acronym | SALEEM |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
1. Post-traumatic stress disorder symptoms measured using a self-report questionnaire at baseline, 3, 6, and 9 months |
| Key secondary outcome measure(s) |
1. Perceived stress measured using self-report questionnaires at baseline, 3, 6, and 9 months |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 59 Years |
| Sex | All |
| Target sample size at registration | 136 |
| Total final enrolment | 143 |
| Key inclusion criteria | 1. Informed consent given 2. Aged 16-59 years 3. Living in the selected refugee camp |
| Key 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 |
| Date of first enrolment | 01/03/2021 |
| Date of final enrolment | 31/08/2021 |
Locations
Countries of recruitment
- Greece
Study participating centre
Larissa
415 00
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/09/2024 | 16/09/2024 | Yes | No | |
| Protocol article | 21/11/2021 | 20/02/2023 | Yes | No | |
| Participant information sheet | version v2 | 24/11/2020 | 08/02/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN16291983_PIS_v2_24Nov2020.pdf
- uploaded 08/02/2021
Editorial Notes
16/09/2024: Publication reference added.
16/06/2023: The intention to publish date
20/02/2023: Publication reference added.
16/12/2022: The following changes were made to the trial record:
1. The acronym was changed from REMEX to SALEEM.
2. The total final enrolment was added.
3. The intention to publish date was changed from 31/12/2022 to 30/06/2023.
08/02/2021: The participant information sheet was uploaded as an additional file.
04/01/2021: Trial’s existence confirmed by Ethikkommission Nordwest- und Zentralschweiz (EKNZ).
