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

October 14, 2015 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4012
        • Psychiatric Hospital of the University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in the ability to work (h/d / %)
Time Frame: baseline and 15 months
baseline and 15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in the ability to work (h/d / %)
Time Frame: baseline and 6 months
baseline and 6 months
Change in the ability to work (h/d / %)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in participation skills (sum score)
Time Frame: baseline and 15 months
baseline and 15 months
Change in participation skills (sum score)
Time Frame: baseline and 6 months
baseline and 6 months
Change in participation skills (sum score)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in psychological functioning (sum scores)
Time Frame: baseline and 15 months
baseline and 15 months
Change in psychological functioning (sum scores)
Time Frame: baseline and 6 months
baseline and 6 months
Change in psychological functioning (sum scores)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in subjective sleep quality (sum score)
Time Frame: baseline and 15 months
baseline and 15 months
Change in subjective sleep quality (sum score)
Time Frame: baseline and 6 months
baseline and 6 months
Change in subjective sleep quality (sum score)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in subjective sleep quality (sum score)
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change in subjective sleep quality (sum score)
Time Frame: baseline and 4 weeks
baseline and 4 weeks
Change in subjectively perceived stress (sum score)
Time Frame: baseline and 15 months
baseline and 15 months
Change in subjectively perceived stress (sum score)
Time Frame: baseline and 6 months
baseline and 6 months
Change in subjectively perceived stress (sum score)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in subjectively perceived stress (sum score)
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change in subjectively perceived stress (sum score)
Time Frame: baseline and 4 weeks
baseline and 4 weeks
Change in Clinical Global Impression (sum score)
Time Frame: baseline and 15 months
baseline and 15 months
Change in Clinical Global Impression (sum score)
Time Frame: baseline and 6 months
baseline and 6 months
Change in Clinical Global Impression (sum score)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in Leisure-time physical activity (sum score)
Time Frame: baseline and 15 months
baseline and 15 months
Change in Leisure-time physical activity (sum score)
Time Frame: baseline and 6 months
baseline and 6 months
Change in Leisure-time physical activity (sum score)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in self-efficacy (sum score)
Time Frame: baseline and 15 months
baseline and 15 months
Change in self-efficacy (sum score)
Time Frame: baseline and 6 months
baseline and 6 months
Change in self-efficacy (sum score)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in self-efficacy (sum score)
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change in self-efficacy (sum score)
Time Frame: baseline and 4 weeks
baseline and 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in physical fitness (VO2max = ml/kg/min)
Time Frame: baseline and 15 months
baseline and 15 months
Change in physical fitness (VO2max = ml/kg/min)
Time Frame: baseline and 6 months
baseline and 6 months
Change in physical fitness (VO2max = ml/kg/min)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in physical fitness (VO2max = ml/kg/min)
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change in physical fitness (VO2max = ml/kg/min)
Time Frame: baseline and 4 weeks
baseline and 4 weeks
Change in perceived fitness (sum score)
Time Frame: baseline and 15 months
baseline and 15 months
Change in perceived fitness (sum score)
Time Frame: baseline and 6 months
baseline and 6 months
Change in perceived fitness (sum score)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change in perceived fitness (sum score)
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change in perceived fitness (sum score)
Time Frame: baseline and 4 weeks
baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Psychiatric Hospital of the University of Basel
Institute for Exercise and Health Sciences, University of Basle, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristin Rabovsky, MD, Psychiatric Hospital of the University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 114/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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