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

NCT04592770 | Completed DMC

• 1 other identifier: KU-DoHPESS-5
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Traumatic Stress Disorder

Keywords

natural environment; walking; post traumatic growth; traumatic stress

Outcome Measures

Primary Outcomes (2)

• 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.

  3 Months

• 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.

  3 Months

Secondary Outcomes (4)

• C- Reactive Protein (CRP)

  3 Months

• Brain-derived neurotrophic factor (BDNF)

  3 Months

• Interleukin-6 (IL-6)

  3 Months

• Cortisol

  3 Months

Other Outcomes (1)

• Heart Rate Variability (HRV)

  3 Months

Study Arms (2)

The experimental intervention (walk):

EXPERIMENTAL

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.

Behavioral: Nature based walk therapy

The control intervention (sit & relax):

PLACEBO COMPARATOR

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.

Behavioral: Sit in nature

Interventions

Nature based walk therapy BEHAVIORAL

10 minutes stretching exercises followed by walk in nature for 50 minutes

Also known as: Experimental

The experimental intervention (walk):

Sit in nature BEHAVIORAL

Sit in nature for 60 minutes

Also known as: Control

The control intervention (sit & relax):

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Karachi: lead

Study Sites (1)

Shamoon Noushad

Karachi, Sindh, 78500, Pakistan

Location

Related Publications (13)

• Alper B, Erdogan B, Erdogan MO, Bozan K, Can M. Associations of Trauma Severity with Mean Platelet Volume and Levels of Systemic Inflammatory Markers (IL1beta, IL6, TNFalpha, and CRP). Mediators Inflamm. 2016;2016:9894716. doi: 10.1155/2016/9894716. Epub 2016 Apr 5.

  PMID: 27127347 BACKGROUND

• Brown DK, Barton JL, Gladwell VF. Viewing nature scenes positively affects recovery of autonomic function following acute-mental stress. Environ Sci Technol. 2013 Jun 4;47(11):5562-9. doi: 10.1021/es305019p. Epub 2013 May 16.

  PMID: 23590163 BACKGROUND

• Gladwell VF, Brown DK, Barton JL, Tarvainen MP, Kuoppa P, Pretty J, Suddaby JM, Sandercock GR. The effects of views of nature on autonomic control. Eur J Appl Physiol. 2012 Sep;112(9):3379-86. doi: 10.1007/s00421-012-2318-8. Epub 2012 Jan 21.

  PMID: 22270487 BACKGROUND

• Gladwell VF, Brown DK, Wood C, Sandercock GR, Barton JL. The great outdoors: how a green exercise environment can benefit all. Extrem Physiol Med. 2013 Jan 3;2(1):3. doi: 10.1186/2046-7648-2-3.

  PMID: 23849478 BACKGROUND

• Hartig T, Mitchell R, de Vries S, Frumkin H. Nature and health. Annu Rev Public Health. 2014;35:207-28. doi: 10.1146/annurev-publhealth-032013-182443. Epub 2014 Jan 2.

  PMID: 24387090 BACKGROUND

• Kerai SM, Khan UR, Islam M, Asad N, Razzak J, Pasha O. Post-traumatic stress disorder and its predictors in emergency medical service personnel: a cross-sectional study from Karachi, Pakistan. BMC Emerg Med. 2017 Aug 29;17(1):26. doi: 10.1186/s12873-017-0140-7.

  PMID: 28851280 BACKGROUND

• Kondo MC, Fluehr JM, McKeon T, Branas CC. Urban Green Space and Its Impact on Human Health. Int J Environ Res Public Health. 2018 Mar 3;15(3):445. doi: 10.3390/ijerph15030445.

  PMID: 29510520 BACKGROUND

• Britton E, Kindermann G, Domegan C, Carlin C. Blue care: a systematic review of blue space interventions for health and wellbeing. Health Promot Int. 2020 Feb 1;35(1):50-69. doi: 10.1093/heapro/day103.

  PMID: 30561661 BACKGROUND

• Li Q, Otsuka T, Kobayashi M, Wakayama Y, Inagaki H, Katsumata M, Hirata Y, Li Y, Hirata K, Shimizu T, Suzuki H, Kawada T, Kagawa T. Acute effects of walking in forest environments on cardiovascular and metabolic parameters. Eur J Appl Physiol. 2011 Nov;111(11):2845-53. doi: 10.1007/s00421-011-1918-z. Epub 2011 Mar 23.

  PMID: 21431424 BACKGROUND

• Michopoulos V, Norrholm SD, Jovanovic T. Diagnostic Biomarkers for Posttraumatic Stress Disorder: Promising Horizons from Translational Neuroscience Research. Biol Psychiatry. 2015 Sep 1;78(5):344-53. doi: 10.1016/j.biopsych.2015.01.005. Epub 2015 Jan 30.

  PMID: 25727177 BACKGROUND

• Ohly H, White MP, Wheeler BW, Bethel A, Ukoumunne OC, Nikolaou V, Garside R. Attention Restoration Theory: A systematic review of the attention restoration potential of exposure to natural environments. J Toxicol Environ Health B Crit Rev. 2016;19(7):305-343. doi: 10.1080/10937404.2016.1196155. Epub 2016 Sep 26.

  PMID: 27668460 BACKGROUND

• Valtchanov D, Barton KR, Ellard C. Restorative effects of virtual nature settings. Cyberpsychol Behav Soc Netw. 2010 Oct;13(5):503-12. doi: 10.1089/cyber.2009.0308. Epub 2010 Feb 25.

  PMID: 20950174 BACKGROUND

• Noushad S, Ahmed S, Ansari B, Mustafa UH, Saleem Y, Hazrat H. Physiological biomarkers of chronic stress: A systematic review. Int J Health Sci (Qassim). 2021 Sep-Oct;15(5):46-59.

  PMID: 34548863 BACKGROUND

Related Links

• Study Results

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic Acid

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Isothiocyanates; Isocyanates; Sulfur Compounds

Study Officials

• Basit Ansari, Ph.D

  University of Karachi

  STUDY CHAIR

• Sadaf Ahmed, Ph.D

  University of Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2021
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)