Promoting Physical Activity in People With Schizophrenia. (ProActiveS)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProActiveS
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia focused on measuring physical activity, intervention, walking
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ProActiveS
Arm Description
As this was a feasibility study, all participants received the intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in weekly step count.
Activity was measured objectively using accelerometers.
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.
Full Information
NCT ID
NCT03514212
First Posted
March 27, 2018
Last Updated
May 1, 2018
Sponsor
University of Edinburgh
Collaborators
NHS Lothian, Chief Scientist Office of the Scottish Government
1. Study Identification
Unique Protocol Identification Number
NCT03514212
Brief Title
Promoting Physical Activity in People With Schizophrenia.
Acronym
ProActiveS
Official Title
Testing an Intervention to Increase Physical Activity in Schizophrenia: A Feasibility and Acceptability Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 24, 2015 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian, Chief Scientist Office of the Scottish Government
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
physical activity, intervention, walking
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProActiveS
Arm Type
Experimental
Arm Description
As this was a feasibility study, all participants received the intervention.
Intervention Type
Behavioral
Intervention Name(s)
ProActiveS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and acceptability of the intervention.
Description
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.
Time Frame
Post intervention (12 weeks).
Secondary Outcome Measure Information:
Title
Change in weekly step count.
Description
Activity was measured objectively using accelerometers.
Time Frame
At baseline and at intervention end point (12 weeks).
Title
Change in activity levels.
Description
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.
Time Frame
Throughout the 12-week intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M Lawrie, MBChB,FRCPsych
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gillian E Mead, MBChB,FRCPEd
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24085733
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.
Results Reference
background
Learn more about this trial
Promoting Physical Activity in People With Schizophrenia.
We'll reach out to this number within 24 hrs