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MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke (MONSS)

Primary Purpose

Stroke, Acute, Behavior, Physical Inactivity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Everyday Life is Rehabilitation
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke, Acute

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Verified ischemic stroke or intracerebral hemorrhage Modified rankin score (mRS) 1-3 at discharge Discharged with at rehabilitation plan within 1-14 hospitalization days Able to ambulate independently Speak and understand Danish Exclusion Criteria: Aphasia Unable to give informed consent Unable to ambulate independently Mental illness Other co-morbidity like terminal cancer.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Sedentary time
    Time participants spend with sedentary behavior compared between the intervention and control group

    Secondary Outcome Measures

    Physical activity scale (PAS2)
    Subjective physical activity
    The Stroke Specific Quality of Life Scale (SS-QOL)
    Quality of life
    The General Self-efficacy Scale (GSES)
    self-efficacy
    The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire
    Fatigue
    Patient health questionnaire (PHQ-9)
    Depression symptoms
    The Fugl Meyer Assessment (FMA)
    The function of upper and lower extremity
    Timed Up & Go (TUG) test
    Mobility
    Montreal Cognitive Assessment (MoCA)
    cognitive assessment
    Glycated hemoglobin (HbA1c)
    Glycated hemoglobin (HbA1c)

    Full Information

    First Posted
    March 23, 2023
    Last Updated
    March 30, 2023
    Sponsor
    Zealand University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05793177
    Brief Title
    MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
    Acronym
    MONSS
    Official Title
    Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zealand University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This randomized control trial (RCT) aims to test the effect of a 12 weeks tailored behavioral intervention on stroke survivors living in the community and compare the results to a control group of stroke survivors participating in standard care. The intervention's purpose is to lower the time spend with sedentary behavior and raise the level of physical activity in stroke survivors throughout their everyday life. The intervention contains two motivational interviews with a focus on goal setting, action planning, motivation, fatigue management, and general information on life after stroke. The primary outcome for behavior change is objectively measured physical activity using an activity tracker (ActivPal4 Micro) and secondary glycohemoglobin and changes in quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute, Behavior, Physical Inactivity, Sedentary Behavior

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Everyday Life is Rehabilitation
    Intervention Description
    Behavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management.
    Primary Outcome Measure Information:
    Title
    Sedentary time
    Description
    Time participants spend with sedentary behavior compared between the intervention and control group
    Time Frame
    12 weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Physical activity scale (PAS2)
    Description
    Subjective physical activity
    Time Frame
    Baseline,12 and 26 weeks follow-up
    Title
    The Stroke Specific Quality of Life Scale (SS-QOL)
    Description
    Quality of life
    Time Frame
    Baseline,12 and 26 weeks follow-up
    Title
    The General Self-efficacy Scale (GSES)
    Description
    self-efficacy
    Time Frame
    Baseline,12 and 26 weeks follow-up
    Title
    The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire
    Description
    Fatigue
    Time Frame
    Baseline,12 and 26 weeks follow-up
    Title
    Patient health questionnaire (PHQ-9)
    Description
    Depression symptoms
    Time Frame
    Baseline,12 and 26 weeks follow-up
    Title
    The Fugl Meyer Assessment (FMA)
    Description
    The function of upper and lower extremity
    Time Frame
    Baseline,12 and 26 weeks follow-up
    Title
    Timed Up & Go (TUG) test
    Description
    Mobility
    Time Frame
    Baseline,12 and 26 weeks follow-up
    Title
    Montreal Cognitive Assessment (MoCA)
    Description
    cognitive assessment
    Time Frame
    Baseline
    Title
    Glycated hemoglobin (HbA1c)
    Description
    Glycated hemoglobin (HbA1c)
    Time Frame
    Baseline,6,12 and 26 weeks follow-up

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Verified ischemic stroke or intracerebral hemorrhage Modified rankin score (mRS) 1-3 at discharge Discharged with at rehabilitation plan within 1-14 hospitalization days Able to ambulate independently Speak and understand Danish Exclusion Criteria: Aphasia Unable to give informed consent Unable to ambulate independently Mental illness Other co-morbidity like terminal cancer.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stefan S Bodilsen, MSPT
    Phone
    +4528401595
    Email
    sbodi@regionsjaelland.dk

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36860816
    Citation
    Bodilsen SS, Aadahl M, Wienecke T, Thomsen TH. Development of a tailored intervention targeting sedentary behavior and physical activity in people with stroke and diabetes: A qualitative study using a co-creation framework. Front Rehabil Sci. 2023 Feb 13;4:1114537. doi: 10.3389/fresc.2023.1114537. eCollection 2023.
    Results Reference
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    MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

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