MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Conditions
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Stroke, Acute, Behavior, Physical Inactivity, Sedentary Behavior

Intervention / Treatment
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* Behavioral: Everyday Life is Rehabilitation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Everyday Life is Rehabilitation<br>* Behavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary time | Time participants spend with sedentary behavior compared between the intervention and control group | 12 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity scale (PAS2) | Subjective physical activity | Baseline,12 and 26 weeks follow-up | 
| The Stroke Specific Quality of Life Scale (SS-QOL) | Quality of life | Baseline,12 and 26 weeks follow-up | 
| The General Self-efficacy Scale (GSES) | self-efficacy | Baseline,12 and 26 weeks follow-up | 
| The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire | Fatigue | Baseline,12 and 26 weeks follow-up | 
| Patient health questionnaire (PHQ-9) | Depression symptoms | Baseline,12 and 26 weeks follow-up | 
| The Fugl Meyer Assessment (FMA) | The function of upper and lower extremity | Baseline,12 and 26 weeks follow-up | 
| Timed Up & Go (TUG) test | Mobility | Baseline,12 and 26 weeks follow-up | 
| Montreal Cognitive Assessment (MoCA) | cognitive assessment | Baseline | 
| Glycated hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) | Baseline,6,12 and 26 weeks follow-up |