Physical Activity in Patients With Severe Mental Illness | NCT01329094

Studies
Physical Activity in Patients With Severe Mental Illness

NCT01329094

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Apr 5, 2011Estimated

Enrollment

75Actual

Phase

Not provided

Conditions

Mental Disorders

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Aug 9, 2010

First Submission Date that Met QC Criteria

Apr 4, 2011

First Posted Date

Apr 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2011

Last Update Posted Date

Apr 5, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical activity level	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.	The average physical activity level of the past week is assessed (one week)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Physical disablement, subject to coercive treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene N Jacobsen, PT, Msc	Aarhus University, Risskov	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

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