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Promoting Physical Activity in People With Schizophrenia. (ProActiveS)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProActiveS
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring physical activity, intervention, walking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 27, 2018
    Last Updated
    May 1, 2018
    Sponsor
    University of Edinburgh
    Collaborators
    NHS Lothian, Chief Scientist Office of the Scottish Government
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    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
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