Physical Activity in Insurance Medicine: Effects on Patients With Psychiatric Disorders

Depressive Disorder Clinical Trial

— PhysActIV  

Official title:

Physical Activity in Insurance Medicine: Effects on Psycho(-Physio-)Logical Functions, Capacity / Participation Skills, and the Ability to Work in Psychiatric Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01928264
• Other study ID #: 114/13
• Status: Terminated
• Phase: N/A
• First received: August 5, 2013
• Last updated: October 14, 2015
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: October 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

We will conduct a randomized control trial to investigate whether and to what extent regular and guided group physical activity over 12 weeks (2 sessions à 1 hour/week) improves physical fitness and (physio-)psychological functions (like subjective sleep, mental toughness, perceived stress, self-efficacy, etc.), as well as participation skills and the ability to work, in claimants for a disability pension due to psychiatric disorders, whose ability to work had recently been assessed by means of a psychiatric expert opinion. The control group is designed very similar and implies predominantly sedentary leisure time group activities (e.g. playing board games, doing handicrafts). Measures will be performed at baseline, post-test, and at follow ups three and twelve months after post-test, some variables will additionally be assessed 4-weekly during the intervention. We expect that intervention group participants will report and show, respectively, more improved physical fitness, (physio-)psychological functioning and participations skills, as well as increased ability to work, compared to the control group.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Claimants for a disability pension due to a mental disorder, whose ability to work has been recently assessed by means of a psychiatric expert opinion

• Both genders

• 18-55 years old

• Clinical diagnosis of depressive disorder, somatoform disorder, anxiety disorder, personality disorder

• Sufficient competence in understanding, speaking and reading German

• Sufficient cognitive, emotional and social level of functioning to be able to participate in a group

• Physical Activity Readiness Questionnaire without evidence for reduction

• or: Physical activity readiness certificated by the general practitioner

• Informed consent

Exclusion Criteria:

• Comorbidity with a somatic disorder that limits the ability for physical exercises

• Pregnancy

• Ongoing disturbance of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Disease
• Mental Disorders
• Personality Disorder
• Personality Disorders
• Somatoform Disorder
• Somatoform Disorders

Intervention

Behavioral:
• Physical activity

Locations

Country	Name	City	State
Switzerland	Psychiatric Hospital of the University of Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Institute for Exercise and Health Sciences, University of Basle, Switzerland, Psychiatric Hospital of the University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical fitness (VO2max = ml/kg/min)		baseline and 15 months	No
Other	Change in physical fitness (VO2max = ml/kg/min)		baseline and 6 months	No
Other	Change in physical fitness (VO2max = ml/kg/min)		baseline and 12 weeks	No
Other	Change in physical fitness (VO2max = ml/kg/min)		baseline and 8 weeks	No
Other	Change in physical fitness (VO2max = ml/kg/min)		baseline and 4 weeks	No
Other	Change in perceived fitness (sum score)		baseline and 15 months	No
Other	Change in perceived fitness (sum score)		baseline and 6 months	No
Other	Change in perceived fitness (sum score)		baseline and 12 weeks	No
Other	Change in perceived fitness (sum score)		baseline and 8 weeks	No
Other	Change in perceived fitness (sum score)		baseline and 4 weeks	No
Primary	Change in the ability to work (h/d / %)		baseline and 15 months	No
Secondary	Change in the ability to work (h/d / %)		baseline and 6 months	No
Secondary	Change in the ability to work (h/d / %)		baseline and 12 weeks	No
Secondary	Change in participation skills (sum score)		baseline and 15 months	No
Secondary	Change in participation skills (sum score)		baseline and 6 months	No
Secondary	Change in participation skills (sum score)		baseline and 12 weeks	No
Secondary	Change in psychological functioning (sum scores)		baseline and 15 months	No
Secondary	Change in psychological functioning (sum scores)		baseline and 6 months	No
Secondary	Change in psychological functioning (sum scores)		baseline and 12 weeks	No
Secondary	Change in subjective sleep quality (sum score)		baseline and 15 months	No
Secondary	Change in subjective sleep quality (sum score)		baseline and 6 months	No
Secondary	Change in subjective sleep quality (sum score)		baseline and 12 weeks	No
Secondary	Change in subjective sleep quality (sum score)		baseline and 8 weeks	No
Secondary	Change in subjective sleep quality (sum score)		baseline and 4 weeks	No
Secondary	Change in subjectively perceived stress (sum score)		baseline and 15 months	No
Secondary	Change in subjectively perceived stress (sum score)		baseline and 6 months	No
Secondary	Change in subjectively perceived stress (sum score)		baseline and 12 weeks	No
Secondary	Change in subjectively perceived stress (sum score)		baseline and 8 weeks	No
Secondary	Change in subjectively perceived stress (sum score)		baseline and 4 weeks	No
Secondary	Change in Clinical Global Impression (sum score)		baseline and 15 months	No
Secondary	Change in Clinical Global Impression (sum score)		baseline and 6 months	No
Secondary	Change in Clinical Global Impression (sum score)		baseline and 12 weeks	No
Secondary	Change in Leisure-time physical activity (sum score)		baseline and 15 months	No
Secondary	Change in Leisure-time physical activity (sum score)		baseline and 6 months	No
Secondary	Change in Leisure-time physical activity (sum score)		baseline and 12 weeks	No
Secondary	Change in self-efficacy (sum score)		baseline and 15 months	No
Secondary	Change in self-efficacy (sum score)		baseline and 6 months	No
Secondary	Change in self-efficacy (sum score)		baseline and 12 weeks	No
Secondary	Change in self-efficacy (sum score)		baseline and 8 weeks	No
Secondary	Change in self-efficacy (sum score)		baseline and 4 weeks	No