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

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592770
• Other study ID #: KU-DoHPESS-5
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: August 10, 2021

Study information

• Verified date: February 2023
• Source: University of Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Nature based walk therapy
10 minutes stretching exercises followed by walk in nature for 50 minutes
• Sit in nature
Sit in nature for 60 minutes

Locations

Country	Name	City	State
Pakistan	Shamoon Noushad	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
University of Karachi

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate Variability (HRV)	Change in the HRV will be observed among the subjects enrolled in the experimental group as compared to the control group	3 Months
Primary	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
Primary	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	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	3 Months
Secondary	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	3 Months
Secondary	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	3 Months
Secondary	Cortisol	Change in the cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group	3 Months

External Links

•   Study Protocol
•   Study Results