Clinical trial NCT03514212: Promoting Physical Activity in People With Schizophrenia.
Official title: Testing an Intervention to Increase Physical Activity in Schizophrenia: A Feasibility and Acceptability Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: physical activity
intervention
walking
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: Chief Scientist Office of the Scottish Government
First posted: 2018-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: OTHER

Brief summary: People with schizophrenia die approximately 20 years earlier than those in the general population, and this is mostly due to cardiovascular disease (CVD) and related poor physical health. The risk factors for CVD are significantly more prevalent in people with schizophrenia, but they are largely preventable by, for example, engaging in regular PA. Existing interventions to increase PA in schizophrenia are generally atheoretical and lack manualisation and appropriate evaluation, thus reducing their usefulness to clinical practice.

Drawing on the MRC Guidelines for the development and evaluation of complex interventions, a 12-week intervention was developed and informed by a systematic review of the factors that influence PA in people with schizophrenia and a qualitative study exploring the barriers and motivators to PA (n=10). The feasibility and acceptability of the intervention was then investigated in an uncontrolled pilot study (n=20).

The pilot study demonstrated that the intervention was both feasible and acceptable to people with schizophrenia. The retention rate was 90% (n=18), and reasons given for dropout were work commitments and other illness.

Of the 18 who completed the intervention, 17 (94%) increased their weekly step count, 14 (78%) met current public health guidelines of 10,000 steps per day at some point during the 12 weeks, 10 (56%) experienced some weight loss, 12 (67%) took up an additional health promotion opportunity (e.g., improving diet, stopping smoking, joining a gym) and 13 (72%) took up another form of PA in addition to walking (e.g., swimming).

Participants found the intervention enjoyable and thought it should be offered to everyone with schizophrenia. The intervention also proved to be feasible and acceptable to staff who referred patients to take part. Informal feedback from staff confirmed the need for such a service, particularly for those taking anti-psychotic medication, and indicated that, if it was to be implemented more widely, it would be a popular and useful resource.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or related disorder (e.g., schizoaffective disorder, psychosis)
* Living in the community
* Clinically stable for at least 8 weeks prior to intervention enrolment
* Ability to safely walk unaided

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Feasibility and acceptability of the intervention.
timeFrame: Post intervention (12 weeks).
Secondary outcomes:
measure: Change in weekly step count.
timeFrame: At baseline and at intervention end point (12 weeks).
measure: Change in activity levels.
timeFrame: Throughout the 12-week intervention.
Other outcomes:
Locations:
Study officials:
affiliation: University of Edinburgh
name: Stephen M Lawrie, MBChB,FRCPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Gillian E Mead, MBChB,FRCPEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNamee L, Mead G, MacGillivray S, Lawrie SM. Schizophrenia, poor physical health and physical activity: evidence-based interventions are required to reduce major health inequalities. Br J Psychiatry. 2013 Sep;203(3):239-41. doi: 10.1192/bjp.bp.112.125070.