Clinical trial NCT01152086: The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Suicide
Hopelessness
Keywords: Physical activity
mountain hiking
exercise
training program
hopelessness
chronic suicidality
depression
suicide attempt
suicide
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Suicide is a major public health issue with estimated 1 million deaths worldwide within the last year. Physical activity and nature recreation might be protective factors against suicidal behaviour, suicidal ideation and contributing factors like depression and hopelessness.

In this randomized controlled cross-over intervention study the investigators aim to investigate the physical and psychological effects of a 9 weeks hiking program in chronically suicidal patients. The investigators aim to enroll 24 patients suffering from chronic suicidality, defined as at least one attempted suicide and a hopelessness greater than 26 in Beck's Hopelessness Scale summary score. At baseline patients will undergo pre-tests including questionnaires to assess suicide ideation, hopelessness, depression, anxiety, quality of life and health-related physical activity, physiological investigations to assess exercise capacity and blood investigations. Randomly assigned 12 patients start with the 9 weeks supervised mountain hiking program followed by a 9-week-period without supervised exercise program. The other 12 patients start with 9 weeks without supervised exercise program followed by a 9-week-period of supervised mountain hiking program. The mountain hiking program includes 2 training sessions per week with a duration of 3 hours per session. The hiking intervention will be performed within 70-85% of heart rate reserve and gymnastics for body and nature perception, mobilisation and stretching will enrich the training program. Further investigations including questionnaire-assessments, assessment of exercise capacity and blood investigations will be scheduled 9 and 18 weeks after the study start. In addition a daily assessment of several suicide risk-factors based on a web-based questionnaire will be done over the full study period. Within this mountain hiking program the investigators hope to reduce hopelessness in chronically suicidal patients.


Eligibility criteria: Inclusion Criteria:

Chronically suicidal defined as:

* at least one attempted suicide
* BHS summary scale \> 26

Exclusion Criteria:

* Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
* not oriented in time and space
* demented
* acute psychotic
* cognitively impaired
* insufficient german language skills

Primary outcomes:
measure: Hopelessness
timeFrame: 18 weeks (3 time points)
Secondary outcomes:
measure: Exercise capacity
timeFrame: 18 weeks (3 time points)
measure: Depression
timeFrame: 18 weeks (3 time points)
measure: Anxiety
timeFrame: 18 weeks (3 time points)
measure: Suicide ideation
timeFrame: 18 weeks (3 time points)
measure: Quality of life
timeFrame: 18 weeks (3 time points)
measure: Blood parameters of inflammation
timeFrame: 18 weeks (3 time points)
measure: suicide risk factors
timeFrame: 18 weeks (daily)
measure: health-related physical activity
timeFrame: 18 weeks (3 time points)
Other outcomes:
Locations:
Study officials:
affiliation: Paracelsus Medical University
name: Reinhold Fartacek, MD, MBA
role: STUDY_CHAIR
References:
citation: Babiss LA, Gangwisch JE. Sports participation as a protective factor against depression and suicidal ideation in adolescents as mediated by self-esteem and social support. J Dev Behav Pediatr. 2009 Oct;30(5):376-84. doi: 10.1097/DBP.0b013e3181b33659.
citation: Brown DR, Galuska DA, Zhang J, Eaton DK, Fulton JE, Lowry R, Maynard LM. Psychobiology and behavioral strategies. Physical activity, sport participation, and suicidal behavior: U.S. high school students. Med Sci Sports Exerc. 2007 Dec;39(12):2248-57. doi: 10.1249/mss.0b013e31815793a3.
citation: Simon TR, Powell KE, Swann AC. Involvement in physical activity and risk for nearly lethal suicide attempts. Am J Prev Med. 2004 Nov;27(4):310-5. doi: 10.1016/j.amepre.2004.07.003.
citation: Taliaferro LA, Rienzo BA, Pigg RM Jr, Miller MD, Dodd VJ. Associations between physical activity and reduced rates of hopelessness, depression, and suicidal behavior among college students. J Am Coll Health. 2009 Jan-Feb;57(4):427-36. doi: 10.3200/JACH.57.4.427-436.
citation: Tao FB, Xu ML, Kim SD, Sun Y, Su PY, Huang K. Physical activity might not be the protective factor for health risk behaviours and psychopathological symptoms in adolescents. J Paediatr Child Health. 2007 Nov;43(11):762-7. doi: 10.1111/j.1440-1754.2007.01217.x.