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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everyday Life is Rehabilitation | Behavioral | Behavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary time | Time participants spend with sedentary behavior compared between the intervention and control group | 12 weeks follow-up |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan S Bodilsen, MSPT | Contact | +4528401595 | sbodi@regionsjaelland.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University hospital | Recruiting | Roskilde | 4000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36860816 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001519 | Behavior |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |