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MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05793177
Acronym
MONSS
Enrollment
100
Registered
2023-03-31
Start date
2023-10-01
Completion date
2024-12-31
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Physical Inactivity, Sedentary Behavior, Stroke, Acute

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.

Interventions

BEHAVIORALEveryday Life is Rehabilitation

Behavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management.

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sedentary time12 weeks follow-upTime participants spend with sedentary behavior compared between the intervention and control group

Secondary

MeasureTime frameDescription
Physical activity scale (PAS2)Baseline,12 and 26 weeks follow-upSubjective physical activity
The Stroke Specific Quality of Life Scale (SS-QOL)Baseline,12 and 26 weeks follow-upQuality of life
The Multi-dimensional Fatigue Inventory (MFI-20) questionnaireBaseline,12 and 26 weeks follow-upFatigue
Patient health questionnaire (PHQ-9)Baseline,12 and 26 weeks follow-upDepression symptoms
The General Self-efficacy Scale (GSES)Baseline,12 and 26 weeks follow-upself-efficacy
Timed Up & Go (TUG) testBaseline,12 and 26 weeks follow-upMobility
Montreal Cognitive Assessment (MoCA)Baselinecognitive assessment
Glycated hemoglobin (HbA1c)Baseline,6,12 and 26 weeks follow-upGlycated hemoglobin (HbA1c)
The Fugl Meyer Assessment (FMA)Baseline,12 and 26 weeks follow-upThe function of upper and lower extremity

Countries

Denmark

Contacts

Primary ContactStefan S Bodilsen, MSPT
sbodi@regionsjaelland.dk+4528401595

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026