Promoting Physical Activity in People With Schizophrenia.

Schizophrenia Clinical Trial

— ProActiveS  

Official title:

Testing an Intervention to Increase Physical Activity in Schizophrenia: A Feasibility and Acceptability Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514212
• Other study ID #: 2015/0383
• Secondary ID: 185550DTF/12/121
• Status: Completed
• Phase: N/A
• Start date: November 24, 2015
• Est. completion date: August 31, 2016

Study information

• Verified date: April 2018
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• ProActiveS
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Chief Scientist Office of the Scottish Government, NHS Lothian

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of the intervention.	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	Change in weekly step count.	Activity was measured objectively using accelerometers.	At baseline and at intervention end point (12 weeks).
Secondary	Change in activity levels.	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.