Promoting Physical Activity in People With Schizophrenia. (ProActiveS)
Testing an Intervention to Increase Physical Activity in Schizophrenia: A Feasibility and Acceptability Study.
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ProActiveS
As this was a feasibility study, all participants received the intervention.
|
A 12-week behaviour change intervention, during which time participants met with the researcher weekly and used a pedometer to measure step count and completed an activity diary to monitor progress, set goals and plan how to cope with identified barriers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility and acceptability of the intervention.
Time Frame: Post intervention (12 weeks).
|
Feasibility and acceptability of the intervention was evaluated using mixed-methods to explore recruitment, delivery, reasons for drop-out, participant feedback (positive and negative), and suggestions for improvement.
This was quantitatively assessed by recording the number of eligible participants that agreed to participate and the number of participants that enrolled but dropped out.
Participants were also asked to complete a feedback form, which contained space for free text, during the last session of the intervention.
|
Post intervention (12 weeks).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weekly step count.
Time Frame: At baseline and at intervention end point (12 weeks).
|
Activity was measured objectively using accelerometers.
|
At baseline and at intervention end point (12 weeks).
|
|
Change in activity levels.
Time Frame: Throughout the 12-week intervention.
|
Participants used their pedometers to measure daily step count and record totals in their activity diaries.
Participants also recorded sedentary time in their activity diaries.
|
Throughout the 12-week intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen M Lawrie, MBChB,FRCPsych, University of Edinburgh
- Principal Investigator: Gillian E Mead, MBChB,FRCPEd, University of Edinburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/0383
- 185550 (Other Identifier: IRAS Project ID)
- DTF/12/12 (Other Grant/Funding Number: Chief Scientist Office)
- 15-SS-0192 (Other Identifier: NHS Lothian REC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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