Physical Activity in Patients With Severe Mental Illness

This study has been completed.

Sponsor:

Information provided by:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01329094

First received: August 9, 2010

Last updated: April 4, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 9, 2010

Last Updated Date

April 4, 2011

Start Date ^ICMJE

March 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Physical activity level [ Time Frame: The average physical activity level of the past week is assessed (one week) ] [ Designated as safety issue: No ]

The physical activity level is assessed using the Physical Activity Scale, which is based ion the concept that the intensity of physical activity can be expressed in metabolic equivalents.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01329094 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Physical Activity in Patients With Severe Mental Illness

Official Title ^ICMJE

Physical Activity in Patients With Severe Mental Illness

Brief Summary

The aim of the study was to evaluate the applicability of the Physical Activity Scale (PAS) in relation to patients with severe mental illness. The study hypothesised that physical activity levels among patients with severe mental illness was significantly lower than healthy controls. The physical activity level of patients with severe mental illness attending Aarhus University Hospital, Risskov in comparisons with healthy controls matched on gender and age was assessed with PAS.

Detailed Description

The study population of interest was psychiatric in- or outpatients from Aarhus University Hospital , Risskov, some of whom were referred for physiotherapeutic treatment. The patients were compared with healthy controls matched on gender and age, recruited from hospital staff including administrative employees.Patients and controls were included in the study after giving informed consent, according to the Declaration of Helsinki 2008. All participants assessed their physical activity level by completing the PAS questionnaire twice within a time period of 5-7 days for evaluation of the test-retest reliability of PAS. For patients, PAS was administered as an interview, and for controls as a self-questionnaire. Several physiotherapists (PTs) were involved in interviewing the patients.

In total, 47 hospitalized patients or outpatients and 28 controls were included in the study. In comparison with controls, the physical activity level of daily life of the patients was statistically significantly lower, even though the average physical activity level of the healthy controls was just above 'moderate physical activity'.

There was a satisfactory test-retest reliability of PAS when applied to both mentally ill patients and healthy controls. PAS was found to be an applicable method for evaluating physical activity levels in patients with severe mental illness, and also useful in measuring changes in physical activity levels.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Psychiatric in- and outpatients admitted to Aarhus University Hospital, Risskov, Denmark

Condition ^ICMJE

Mental Disorders

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients with severe mental illness
In-patients and out-patients with severe mental illness attending treatment at Aarhus University Hospital, Risskov.
Healthy controls
Healthy controls recruited from staff members at Aarhus University Hospital, Risskov

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All in and outpatients attending psychiatric treatment at Aarhus University Hospital, Risskov

Exclusion Criteria:

Physical disablement, subject to coercive treatment

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01329094

Other Study ID Numbers ^ICMJE

Lene Nyboe Jacobsen 2

Has Data Monitoring Committee

Responsible Party

Lene Nyboe Jacobsen, Aarhus University

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lene N Jacobsen, PT, Msc

Aarhus University, Risskov

Information Provided By

University of Aarhus

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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