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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Terminated

CT.gov ID

NCT01928264

Collaborator

Psychiatric Hospital of the University of Basel (Other), Institute for Exercise and Health Sciences, University of Basle, Switzerland (Other)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder Somatoform Disorder Anxiety Disorder Personality Disorder	Behavioral: Physical activity	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical activity Physical activity group program over 12 weeks; 1 hour sessions, 2 times a week	Behavioral: Physical activity
No Intervention: Leisure time activities Predominantly sedentary leisure time group activities, like playing board games, doing handicrafts, etc.; 12 weeks, 1 hour sessions, 2 times a week

Arm

Intervention/Treatment

Experimental: Physical activity

Physical activity group program over 12 weeks; 1 hour sessions, 2 times a week

Behavioral: Physical activity

No Intervention: Leisure time activities

Predominantly sedentary leisure time group activities, like playing board games, doing handicrafts, etc.; 12 weeks, 1 hour sessions, 2 times a week

Outcome Measures

Primary Outcome Measures

Change in the ability to work (h/d / %) [baseline and 15 months]

Secondary Outcome Measures

Change in the ability to work (h/d / %) [baseline and 6 months]
Change in the ability to work (h/d / %) [baseline and 12 weeks]
Change in participation skills (sum score) [baseline and 15 months]
Change in participation skills (sum score) [baseline and 6 months]
Change in participation skills (sum score) [baseline and 12 weeks]
Change in psychological functioning (sum scores) [baseline and 15 months]
Change in psychological functioning (sum scores) [baseline and 6 months]
Change in psychological functioning (sum scores) [baseline and 12 weeks]
Change in subjective sleep quality (sum score) [baseline and 15 months]
Change in subjective sleep quality (sum score) [baseline and 6 months]
Change in subjective sleep quality (sum score) [baseline and 12 weeks]
Change in subjective sleep quality (sum score) [baseline and 8 weeks]
Change in subjective sleep quality (sum score) [baseline and 4 weeks]
Change in subjectively perceived stress (sum score) [baseline and 15 months]
Change in subjectively perceived stress (sum score) [baseline and 6 months]
Change in subjectively perceived stress (sum score) [baseline and 12 weeks]
Change in subjectively perceived stress (sum score) [baseline and 8 weeks]
Change in subjectively perceived stress (sum score) [baseline and 4 weeks]
Change in Clinical Global Impression (sum score) [baseline and 15 months]
Change in Clinical Global Impression (sum score) [baseline and 6 months]
Change in Clinical Global Impression (sum score) [baseline and 12 weeks]
Change in Leisure-time physical activity (sum score) [baseline and 15 months]
Change in Leisure-time physical activity (sum score) [baseline and 6 months]
Change in Leisure-time physical activity (sum score) [baseline and 12 weeks]
Change in self-efficacy (sum score) [baseline and 15 months]
Change in self-efficacy (sum score) [baseline and 6 months]
Change in self-efficacy (sum score) [baseline and 12 weeks]
Change in self-efficacy (sum score) [baseline and 8 weeks]
Change in self-efficacy (sum score) [baseline and 4 weeks]

Other Outcome Measures

Change in physical fitness (VO2max = ml/kg/min) [baseline and 15 months]
Change in physical fitness (VO2max = ml/kg/min) [baseline and 6 months]
Change in physical fitness (VO2max = ml/kg/min) [baseline and 12 weeks]
Change in physical fitness (VO2max = ml/kg/min) [baseline and 8 weeks]
Change in physical fitness (VO2max = ml/kg/min) [baseline and 4 weeks]
Change in perceived fitness (sum score) [baseline and 15 months]
Change in perceived fitness (sum score) [baseline and 6 months]
Change in perceived fitness (sum score) [baseline and 12 weeks]
Change in perceived fitness (sum score) [baseline and 8 weeks]
Change in perceived fitness (sum score) [baseline and 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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