Effect of Exercise on Post-traumatic Growth Among Health Care Providers With Post-traumatic Stress
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of designing this randomized control trial is to observe the effect of
      nature-based walk on post-traumatic growth and Psychophysiological alterations associated
      with it, in traumatic stress among health care providers of Karachi Pakistan. This study is
      planned to investigate the recreational exposure to the natural environment for the promotion
      of PTG, in the traumatic stress subjects and to determine whether PTG is associated with
      psychophysiological alterations, i.e. C-Reactive Protein, Brain Derived Neurotropic Factor,
      Interleukin-6, Cortisol, and Heart Rate Variability. Subjects who had experienced any
      traumatic event in the last 12 months will be recruited, and at baseline, the participant
      will be assessed with Trauma Symptom Checklist 40 to evaluate trauma intensity. Moreover,
      subjects who had developed PTG or did not have any trauma intensity will be excluded from the
      study. Blinded treatment will be provided to subjects meeting eligibility criteria and will
      be randomized into two groups sequentially as they agree to participate. The nature-based
      walk will be used as intervention vs the control (relax in nature). The study outcomes will
      be monitored in subjects of both groups at different intervals, i.e. at baseline and 3-month
      follow-up (post-interventional).
    

Detailed description: 
      Plan of work

        -  Enrollment: Those subjects who had experienced any traumatic event in the last 12 months
           will be enrolled.

        -  Assessment of eligibility: Subject meeting eligibility criteria will be included in the
           study.

        -  Baseline assessment: All the variables, i.e. Post-traumatic growth inventory (PTGI),
           Trauma symptom checklist-40 (TSC-40), Traumatic stress scale (TSS), C-Reactive protein
           (CRP), Brain-derived neurotrophic factor (BDNF), Interleukin-6 (IL-6), Cortisol and
           Heart rate variability (HRV) will be measured at baseline.

        -  Randomization: Subjects based on eligibility criteria will be randomly allocated to the
           experimental or control group sequentially as they agree to participate.

        -  Allocation: A booklet with detailed instructions will be provided to the study subjects
           according to the groups allocated.

        -  Follow-up assessment: After 3 months, all the variables measured at the baseline phase
           will be measured again.

        -  Statistical Analysis: Pre & post-analysis will be conducted in this phase.

      Participants Subjects for the present study will be recruited from 5 Health care
      organizations based in Karachi, Pakistan. The targeted population includes subjects from
      diverse ethnicity and considered eligible for participation in the study if they indicated in
      a pre-screening form that they had experienced a traumatic event. These subjects will be
      invited to participate in the study through advertisements on the notice board of each
      center. Written informed consent will be obtained from each study subject after providing
      detailed information regarding the objectives of the study and its duration.

      Randomization Subjects based on eligibility criteria will be randomly allocated to the
      experimental or control group in the 1:1 ratio. Computer-generated random numbers will be
      used for randomization. After taking the subject's basic information, a unique code will be
      provided to each included subject by the study center. The code will be mentioned in each
      form of each subject.

      Interventions • The experimental intervention: In this group, the nature walk will take place
      in a conserved and by far the largest recreational area of Karachi city. The safari park
      covering an area of 148 acres (0.60 km2), It has a zoo, geared with woodland, mountain
      viewing, safari tracks, as well as two natural lakes. The experiment will take place in the
      afternoon on a 5 km marked area. The duration of the stretching exercise sessions will be of
      10 minutes followed by 50 minutes' walk session five times per week (total 12 weeks).
      participants will be asked to walk at moderate pace.

      • The control intervention: Subjects will undergo 12 weeks of nature therapy that includes
      exposure to natural landscapes. The duration of the sessions will be 60 minutes five times
      per week. The subjects will be asked to sit and relax in the evening, in the same
      recreational area which is used for the experimental group.
    

Intervention name(s): Nature based walk therapy; Sit in nature
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 minutes stretching exercises followed by walk in nature for 50 minutes; Sit in nature for 60 minutes
Other intervention name(s): Experimental; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: natural environment; walking; post traumatic growth; traumatic stress