MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Stroke, Acute Clinical Trial

— MONSS  

Official title:

Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05793177
• Other study ID #: MONSS
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Zealand University Hospital
• Contact: Stefan S Bodilsen, MSPT
• Phone: +4528401595
• Email: sbodi[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior
• Physical Inactivity
• Sedentary Behavior
• Stroke
• Stroke, Acute

Intervention

Behavioral:
• Everyday Life is Rehabilitation
Behavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedentary time	Time participants spend with sedentary behavior compared between the intervention and control group	12 weeks follow-up
Secondary	Physical activity scale (PAS2)	Subjective physical activity	Baseline,12 and 26 weeks follow-up
Secondary	The Stroke Specific Quality of Life Scale (SS-QOL)	Quality of life	Baseline,12 and 26 weeks follow-up
Secondary	The General Self-efficacy Scale (GSES)	self-efficacy	Baseline,12 and 26 weeks follow-up
Secondary	The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire	Fatigue	Baseline,12 and 26 weeks follow-up
Secondary	Patient health questionnaire (PHQ-9)	Depression symptoms	Baseline,12 and 26 weeks follow-up
Secondary	The Fugl Meyer Assessment (FMA)	The function of upper and lower extremity	Baseline,12 and 26 weeks follow-up
Secondary	Timed Up & Go (TUG) test	Mobility	Baseline,12 and 26 weeks follow-up
Secondary	Montreal Cognitive Assessment (MoCA)	cognitive assessment	Baseline
Secondary	Glycated hemoglobin (HbA1c)	Glycated hemoglobin (HbA1c)	Baseline,6,12 and 26 weeks follow-up