MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Not Applicable

Recruiting

• Conditions: Behavior; Physical Inactivity; Sedentary Behavior; Stroke, Acute
• Interventions: Behavioral: Everyday Life is Rehabilitation

• Registration Number: NCT05793177
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-03-31
• Study Start: 2023-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2024-10-15
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Everyday Life is Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Sedentary time	12 weeks follow-up	Time participants spend with sedentary behavior compared between the intervention and control group

Secondary Outcome Measures

Name	Time	Method
The General Self-efficacy Scale (GSES)	Baseline,12 and 26 weeks follow-up	self-efficacy
Physical activity scale (PAS2)	Baseline,12 and 26 weeks follow-up	Subjective physical activity
The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire	Baseline,12 and 26 weeks follow-up	Fatigue
The Fugl Meyer Assessment (FMA)	Baseline,12 and 26 weeks follow-up	The function of upper and lower extremity
Montreal Cognitive Assessment (MoCA)	Baseline	cognitive assessment
Patient health questionnaire (PHQ-9)	Baseline,12 and 26 weeks follow-up	Depression symptoms
The Stroke Specific Quality of Life Scale (SS-QOL)	Baseline,12 and 26 weeks follow-up	Quality of life
Timed Up & Go (TUG) test	Baseline,12 and 26 weeks follow-up	Mobility
Glycated hemoglobin (HbA1c)	Baseline,6,12 and 26 weeks follow-up	Glycated hemoglobin (HbA1c)

Trial Locations

Locations (1)

Zealand University hospital; 🇩🇰 Roskilde, Denmark