Physical Activity Intervention for Trauma Afflicted Refugees

February 19, 2024 updated by: Swedish Red Cross University College
This study evaluates the effects of a 10-session physical activity intervention for trauma afflicted refugees. Half of participants will receive this 10-session physical activity intervention and half of the participants will be allocated to the control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Physical activity, particularly when performed in social settings, has been found to constitute an effective stress reliever and has been associated with improved physical and mental well-being, functional capacity and overall life satisfaction, as well as decreased risk of lifestyle diseases in various populations. Physical activity can also revert symptoms of psychiatric disorders such as depression, anxiety, social isolation and dissociation, which is common among trauma afflicted refugees. Many refugees also suffer from PTSD, and so the investigator's aim is to evaluate what effect a 10-session physical activity intervention will have on the mental and physical health of trauma afflicted refugees in a northern European country. The sessions will include physical exercise as well as psychoeducational components, and will be held by a physiotherapist over a period of ten weeks. The physical activity intervention group will be compared to a control-group, who receives two brief lectures on psycho-education in connection to baseline-assessment and follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
183

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 211 21
        • The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Arabic/Persian speaking persons.
  • Persons with refugee background referred to the Swedish Red Cross Treatment Center for trauma related to war and/or torture.
  • Person able to undertake physical activity in a group setting.

Exclusion Criteria:

  • Current serious suicidal ideation, psychosis, serious cognitive impairments, current substance abuse, acute physical injuries or other health conditions that constrain physical activity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical activity Intervention
This arm receives ten two-hour group sessions with physical activity and psycho-educational components, held by a physiotherapist over a period of ten weeks.
Behavioral: Physical activity intervention
Ten sessions (two hours each) with physical activity and psycho-educational components.
Active Comparator: Brief Psycho-education
This arm receives two brief lectures of psycho-education held by a physiotherapist.
Behavioral: Brief psycho-education
Two brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in symptoms of PTSD
Time Frame: Baseline, 10 weeks, and six months
Change in symptoms of PTSD measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5). The PCL-5 is a self-report questionnaire comprising 20 items relating to the main symptoms of PTSD, and which may be divided into the four symptom clusters of PTSD; intrusion, hyperarousal/reactivity, avoidance, and negative alterations in cognitions and mood. Scores range between 0-80. Higher score indicate worse outcome. Initial research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD across samples.
Baseline, 10 weeks, and six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotional distress
Time Frame: Baseline, 10 weeks, and six months
Change in emotional distress (depression and anxiety) assessed by the Hopkins Symptom Checklist (HSCL-25, 25 items). HSCL-25 consists of 10 anxiety and 15 depression items. The items, which refer to how specific symptoms have bothered or distressed the individual during the last week, have four response alternatives ranging from 'not at all' (1) to 'very much' (4). Individual mean item scores will be calculated separately for the anxiety and depression subscales. Respondents with a mean item score above 1.80 and 1.75 classifies as having depression or anxiety, respectively.
Baseline, 10 weeks, and six months
Subjective well-being
Time Frame: Baseline, 10 weeks, and six months
Change in subjective well-being (SWB) assessed by WHO-5 Well-being Index (WHO-5) (5 items). WHO-5 contains five statements of the type 'I have felt happy and in a good mood' and the response alternatives range from 'all the time' (5) to 'never' (0) in relation to the last 2 weeks. The highest possible value of that scale is 100, as the total score is multiplied by a factor of four. Those with values below 50 are classified as having low SWB.
Baseline, 10 weeks, and six months
Health related quality of life
Time Frame: Baseline, 10 weeks, and six months
Change in general health, health-related quality of life, assessed by the EuroQol 5 dimenstions, 5 levels (EQ-5D-5L) (5 items). This instrument consists of a descriptive system including the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondent's answer on each of the five dimensions results in a one-digit number indicating the level selected for that dimension. The digits for the five dimensions are combined in a five-digit number describing the respondent's health state. The health states may be converted into a single index value between zero and one, where zero being equal to death and one being equal to a state of perfect health.
Baseline, 10 weeks, and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swedish Red Cross University College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swedish Red Cross

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fredrik Saboonchi, Professor, Swedish Red Cross University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/1174-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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