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Effect of Exercise on Post-traumatic Growth Among Health Care Providers With Post-traumatic Stress

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Nature based walk therapy
Sit in nature
Sponsored by
University of Karachi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Traumatic Stress Disorder focused on measuring natural environment, walking, post traumatic growth, traumatic stress

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Both genders, aged 16-50 years
  2. Must be disease free (by their reports), there must be no evidence of any metastatic disease.
  3. Fluent in written and spoken the Urdu language (National Language of Pakistan).
  4. Experienced any traumatic event in the last 12 months.
  5. Informed written consent
  6. Being able to walk five times per week. (Participants will be asked to complete the Physical Activity Readiness Questionnaire)

Exclusion Criteria:

  1. Subjects who received a structured psychological intervention for at least six months during the last three years performed by a psychologist or psychiatrist will be excluded.
  2. Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last three years will also be excluded from the study sample.
  3. Those subjects who had developed Post Traumatic Growth. (will be evaluated from Post Traumatic Growth Inventory)
  4. Those subjects who do not have any trauma intensity. (will be evaluated from Trauma Symptom Checklist 40)
  5. Subjects who are at high risk for physical injury during exercise.
  6. Self-reported current and regular exercise in nature

Sites / Locations

  • Shamoon Noushad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The experimental intervention (walk):

The control intervention (sit & relax):

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Post-Traumatic Growth (PTG)
Change in post-traumatic growth from baseline to post-intervention assessment. Post-Traumatic Growth Inventory will be used to assess this outcome. This inventory is comprising of 21 questions based on 5 factors i.e. spiritual modifications, self-conception and alterations in viewpoints, relationship changes, new motivations and interests in life and the discovery of individual resources attainable by themselves and others. Likert scale will be used for rating where 0 means no change experienced, to increasing consequently as 5 means change experienced to a greater degree.
Traumatic Stress
Change in traumatic Stress from baseline to post-intervention assessment. trauma symptom checklist - 40 will be used to assess this outcome. This 40-item instrument measure assesses trauma-related problems in categories like Dissociation, Anxiety, Depression, SATI (Sexual Abuse Trauma Index), Sleep Disturbance & Sexual Problems. using a four point scale ranging from 0 means never, to 3 means often.

Secondary Outcome Measures

C- Reactive Protein (CRP)
Change in the CRP level will be observed among the subjects enrolled in the experimental group as compared to the control group
Brain-derived neurotrophic factor (BDNF)
Change in the BDNF level will be observed among the subjects enrolled in the experimental group as compared to the control group
Interleukin-6 (IL-6)
Change in the IL-6 level will be observed among the subjects enrolled in the experimental group as compared to the control group
Cortisol
Change in the cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group

Full Information

First Posted
October 1, 2020
Last Updated
February 5, 2023
Sponsor
University of Karachi
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1. Study Identification

Unique Protocol Identification Number
NCT04592770
Brief Title
Effect of Exercise on Post-traumatic Growth Among Health Care Providers With Post-traumatic Stress
Official Title
Effect of Nature-based Exercise on Post-traumatic Growth Among People With Post-traumatic Stress: A Randomized Placebo-controlled Trial Designed to Observe Psychophysiological Alterations Before to After Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Karachi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
natural environment, walking, post traumatic growth, traumatic stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The experimental intervention (walk):
Arm Type
Experimental
Arm Description
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.
Arm Title
The control intervention (sit & relax):
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Nature based walk therapy
Other Intervention Name(s)
Experimental
Intervention Description
10 minutes stretching exercises followed by walk in nature for 50 minutes
Intervention Type
Behavioral
Intervention Name(s)
Sit in nature
Other Intervention Name(s)
Control
Intervention Description
Sit in nature for 60 minutes
Primary Outcome Measure Information:
Title
Post-Traumatic Growth (PTG)
Description
Change in post-traumatic growth from baseline to post-intervention assessment. Post-Traumatic Growth Inventory will be used to assess this outcome. This inventory is comprising of 21 questions based on 5 factors i.e. spiritual modifications, self-conception and alterations in viewpoints, relationship changes, new motivations and interests in life and the discovery of individual resources attainable by themselves and others. Likert scale will be used for rating where 0 means no change experienced, to increasing consequently as 5 means change experienced to a greater degree.
Time Frame
3 Months
Title
Traumatic Stress
Description
Change in traumatic Stress from baseline to post-intervention assessment. trauma symptom checklist - 40 will be used to assess this outcome. This 40-item instrument measure assesses trauma-related problems in categories like Dissociation, Anxiety, Depression, SATI (Sexual Abuse Trauma Index), Sleep Disturbance & Sexual Problems. using a four point scale ranging from 0 means never, to 3 means often.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
C- Reactive Protein (CRP)
Description
Change in the CRP level will be observed among the subjects enrolled in the experimental group as compared to the control group
Time Frame
3 Months
Title
Brain-derived neurotrophic factor (BDNF)
Description
Change in the BDNF level will be observed among the subjects enrolled in the experimental group as compared to the control group
Time Frame
3 Months
Title
Interleukin-6 (IL-6)
Description
Change in the IL-6 level will be observed among the subjects enrolled in the experimental group as compared to the control group
Time Frame
3 Months
Title
Cortisol
Description
Change in the cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group
Time Frame
3 Months
Other Pre-specified Outcome Measures:
Title
Heart Rate Variability (HRV)
Description
Change in the HRV will be observed among the subjects enrolled in the experimental group as compared to the control group
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both genders, aged 16-50 years Must be disease free (by their reports), there must be no evidence of any metastatic disease. Fluent in written and spoken the Urdu language (National Language of Pakistan). Experienced any traumatic event in the last 12 months. Informed written consent Being able to walk five times per week. (Participants will be asked to complete the Physical Activity Readiness Questionnaire) Exclusion Criteria: Subjects who received a structured psychological intervention for at least six months during the last three years performed by a psychologist or psychiatrist will be excluded. Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last three years will also be excluded from the study sample. Those subjects who had developed Post Traumatic Growth. (will be evaluated from Post Traumatic Growth Inventory) Those subjects who do not have any trauma intensity. (will be evaluated from Trauma Symptom Checklist 40) Subjects who are at high risk for physical injury during exercise. Self-reported current and regular exercise in nature
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basit Ansari, Ph.D
Organizational Affiliation
University of Karachi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sadaf Ahmed, Ph.D
Organizational Affiliation
University of Karachi
Official's Role
Study Director
Facility Information:
Facility Name
Shamoon Noushad
City
Karachi
State/Province
Sindh
ZIP/Postal Code
78500
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35191173/
Description
Study Results

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Effect of Exercise on Post-traumatic Growth Among Health Care Providers With Post-traumatic Stress

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