MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorZealand University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Aphasia
Unable to give informed consent
Unable to ambulate independently
Mental illness
Trial design
Design model
Single group
Treatments tested in this trial
Everyday Life is Rehabilitation
BehavioralBehavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sedentary time
Time participants spend with sedentary behavior compared between the intervention and control group
Time frame
12 weeks follow-upSecondary outcomes
1
Physical activity scale (PAS2)
Subjective physical activity
Time frame
Baseline,12 and 26 weeks follow-up2
The Stroke Specific Quality of Life Scale (SS-QOL)
Quality of life
Time frame
Baseline,12 and 26 weeks follow-up3
The General Self-efficacy Scale (GSES)
self-efficacy
Time frame
Baseline,12 and 26 weeks follow-up4
The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire
Fatigue
Time frame
Baseline,12 and 26 weeks follow-upSponsors and contacts
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Source ClinicalTrials.gov