NCT01152086

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 23, 2011

Status Verified

September 1, 2011

Enrollment Period

5 months

First QC Date

June 28, 2010

Last Update Submit

September 22, 2011

Conditions

Keywords

Physical activitymountain hikingexercisetraining programhopelessnesschronic suicidalitydepressionsuicide attemptsuicide

Outcome Measures

Primary Outcomes (1)

  • Hopelessness

    Summary score BHS (Beck Hopelessness Scale; 20 items)

    18 weeks (3 time points)

Secondary Outcomes (8)

  • Exercise capacity

    18 weeks (3 time points)

  • Depression

    18 weeks (3 time points)

  • Anxiety

    18 weeks (3 time points)

  • Suicide ideation

    18 weeks (3 time points)

  • Quality of life

    18 weeks (3 time points)

  • +3 more secondary outcomes

Study Arms (2)

Hiking first

ACTIVE COMPARATOR

This group first starts with mountain hiking over 9 weeks followed by a 9 weeks control period.

Other: Mountain hiking in the Austrian and Bavarian Alps

Control first

ACTIVE COMPARATOR

This group first starts with the control period (9 weeks) followed by the 9 weeks mountain hiking intervention.

Other: Mountain hiking in the Austrian and Bavarian Alps

Interventions

Regularly supervised physical exercise training program. Duration over all: 9 weeks; Frequency: 2 times per week; Duration one training-unit: 3 hours; Program: * Endurance training (performed within 70-85% of the maximum heart rate) * Short exercises before hiking (Mobilisation, Body and nature perception, ca. 5 min) * Stretching after hiking (ca. 5 min) * Short break at half-time (ca. 15 min)

Control firstHiking first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronically suicidal defined as:
  • at least one attempted suicide
  • BHS summary scale \> 26

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 19692930BACKGROUND
  • 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.

    PMID: 18046198BACKGROUND
  • 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.

    PMID: 15488361BACKGROUND
  • 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.

    PMID: 19114382BACKGROUND
  • 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.

    PMID: 17924938BACKGROUND

MeSH Terms

Conditions

SuicideMotor ActivityDepressionSuicide, Attempted

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Reinhold Fartacek, MD, MBA

    Paracelsus Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Prof. MD, PhD, MBA

Study Record Dates

First Submitted

June 28, 2010

First Posted

June 29, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 23, 2011

Record last verified: 2011-09