Clinical trial NCT05793177: MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
Official title: Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Behavior
Physical Inactivity
Sedentary Behavior
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Sedentary time
timeFrame: 12 weeks follow-up
Secondary outcomes:
measure: Physical activity scale (PAS2)
timeFrame: Baseline,12 and 26 weeks follow-up
measure: The Stroke Specific Quality of Life Scale (SS-QOL)
timeFrame: Baseline,12 and 26 weeks follow-up
measure: The General Self-efficacy Scale (GSES)
timeFrame: Baseline,12 and 26 weeks follow-up
measure: The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire
timeFrame: Baseline,12 and 26 weeks follow-up
measure: Patient health questionnaire (PHQ-9)
timeFrame: Baseline,12 and 26 weeks follow-up
measure: The Fugl Meyer Assessment (FMA)
timeFrame: Baseline,12 and 26 weeks follow-up
measure: Timed Up & Go (TUG) test
timeFrame: Baseline,12 and 26 weeks follow-up
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline,6,12 and 26 weeks follow-up
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University hospital
Study officials:
References:
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.