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Clinical Trial NCT05793177 (MONSS) for Stroke, Acute, Behavior, Physical Inactivity, Sedentary Behavior is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke (MONSS)

Recruiting
Clinical Trial NCT05793177 (MONSS) is an interventional study for Stroke, Acute, Behavior, Physical Inactivity, Sedentary Behavior that is recruiting. It started on October 1, 2023 with plans to enroll 100 participants. Led by Zealand University Hospital, it is expected to complete by December 31, 2024. The latest data from ClinicalTrials.gov was last updated on July 25, 2024.
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.
Official Title

Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Conditions
Stroke, AcuteBehaviorPhysical InactivitySedentary Behavior
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • MONSS
NCT ID Number
NCT05793177
Start Date (Actual)
2023-10-01
Last Update Posted
2024-07-25
Completion Date (Estimated)
2024-12-31
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Single Group
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention
Everyday Life is Rehabilitation
Behavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management.
No InterventionControl
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Sedentary time
Time participants spend with sedentary behavior compared between the intervention and control group
12 weeks follow-up
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  • 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

  • Aphasia
  • Unable to give informed consent
  • Unable to ambulate independently
  • Mental illness
  • Other co-morbidity like terminal cancer.
Zealand University Hospital logoZealand University Hospital
Study Responsible Party
Stefan Sjørslev Bodilsen, Principal Investigator, Ph.d. student, MSPT, PT, Zealand University Hospital
Study Central Contact
Contact: Stefan S Bodilsen, MSPT, +4528401595, [email protected]
1 Study Locations in 1 Countries
Zealand University hospital, Roskilde, 4000, Denmark
Stefan S Bodilsen, Contact, +4528401595, [email protected]
Recruiting