- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329094
Physical Activity in Patients With Severe Mental Illness
Study Overview
Status
Conditions
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All in and outpatients attending psychiatric treatment at Aarhus University Hospital, Risskov
Exclusion Criteria:
- Physical disablement, subject to coercive treatment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with severe mental illness
In-patients and out-patients with severe mental illness attending treatment at Aarhus University Hospital, Risskov.
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Healthy controls
Healthy controls recruited from staff members at Aarhus University Hospital, Risskov
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity level
Time Frame: The average physical activity level of the past week is assessed (one week)
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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.
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The average physical activity level of the past week is assessed (one week)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lene N Jacobsen, PT, Msc, Aarhus University, Risskov
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lene Nyboe Jacobsen 2
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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