Promoting Physical Activity in People With Schizophrenia.

NCT ID: NCT03514212

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-24
• Study Completion Date: 2016-08-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ProActiveS

As this was a feasibility study, all participants received the intervention.

Group Type: EXPERIMENTAL

ProActiveS

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen M Lawrie, MBChB,FRCPsych

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Gillian E Mead, MBChB,FRCPEd

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

References

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.

Reference Type: BACKGROUND

PMID: 24085733 (View on PubMed)

Other Identifiers

185550

Identifier Type: OTHER

Identifier Source: secondary_id

DTF/12/12

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15-SS-0192

Identifier Type: OTHER

Identifier Source: secondary_id

2015/0383

Identifier Type: -

Identifier Source: org_study_id