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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01152086
Other study ID # Hiking2010
Secondary ID
Status Completed
Phase Phase 4
First received June 28, 2010
Last updated September 22, 2011
Start date July 2010
Est. completion date December 2010

Study information

Verified date September 2011
Source Paracelsus Medical University
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Mountain hiking in the Austrian and Bavarian Alps
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)

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Paracelsus Medical University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical Universtity Salzburg, Institute of Synergetics and Psychotherapy Research, Paracelsus Medical Universtity Salzburg, Suicide Prevention Research Program, Paracelsus Medical Universtity Salzburg

References & 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hopelessness Summary score BHS (Beck Hopelessness Scale; 20 items) 18 weeks (3 time points) No
Secondary Exercise capacity (Watts/kg) 18 weeks (3 time points) No
Secondary Depression BDI-2 summary score (Beck depression inventory 2, 21 items) 18 weeks (3 time points) Yes
Secondary Anxiety Summary score BAI (Beck anxiety inventory, 21 items) 18 weeks (3 time points) No
Secondary Suicide ideation Summary score BSI (Beck suicide ideation inventory, 21 items) 18 weeks (3 time points) No
Secondary Quality of life PLC (Profil der Lebensqualität Chronisch Kranker, 6 subscales: Leistungsvermögen, Genuß- und Entspannungsfähigkeit, Positive Stimmung, Negative Stimmung, Kontaktvermögen, Zugehörigkeitsgefühl) 18 weeks (3 time points) No
Secondary Blood parameters of inflammation Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17; 18 weeks (3 time points) No
Secondary suicide risk factors Several items:
Grundwert aus dem Test zur existentiellen Motivation (Eckhard, 2000, 2 items)
Burdensomeness and Connectedness (Interpersonal needs questionnaire, Joiner 2005, 3 items)
Chronic Suicidality (Paris, 2007, 2 items)
Suicidal Status Form (SSF, Jobes, 2006, 9 items)
Emotionalität und Problembelastung (SNS-subscala, Schiepek, 9 items)
Alcohol consumption (1 item)
Sleep quality (1 item)
Social support (F-SozU-S54, 4 items)
Physical activity (IPAQ-short, 2 items)
Environmental perception (3 items)
Religiousness and spirituality (2 items)
18 weeks (daily) No
Secondary health-related physical activity IPAQ short version (International physical activity questionnaire, 2002) 18 weeks (3 time points) No
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