NCT01928264

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

August 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

August 5, 2013

Last Update Submit

October 14, 2015

Conditions

Depressive DisorderSomatoform DisorderAnxiety DisorderPersonality Disorder

Keywords

Mental disordersPhysical activityDisability pensionDisability pension due to mental illnessAbility to workMental toughness

Outcome Measures

Primary Outcomes (1)

  • Change in the ability to work (h/d / %)

    baseline and 15 months

Secondary Outcomes (29)

  • 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

  • +24 more secondary outcomes

Other Outcomes (10)

  • 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

  • +7 more other outcomes

Study Arms (2)

Physical activity

EXPERIMENTAL

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

Behavioral: Physical activity

Leisure time activities

NO INTERVENTION

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

Interventions

Physical activityBEHAVIORAL
Physical activity

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Comorbidity with a somatic disorder that limits the ability for physical exercises
  • Pregnancy
  • Ongoing disturbance of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Hospital of the University of Basel

Basel, 4012, Switzerland

Location

MeSH Terms

Conditions

Depressive DisorderSomatoform DisordersAnxiety DisordersPersonality DisordersMental DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mood DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kristin Rabovsky, MD

    Psychiatric Hospital of the University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2013

First Posted

August 23, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

CH(1)