Skip to main content
Clinical Trials/NCT05793177
NCT05793177
Recruiting
N/A

Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

Zealand University Hospital1 site in 1 country100 target enrollmentOctober 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke, Acute
Sponsor
Zealand University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Sedentary time
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stefan Sjørslev Bodilsen

Ph.d. student, MSPT, PT

Zealand University Hospital

Eligibility Criteria

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

  • Unable to give informed consent
  • Unable to ambulate independently
  • Mental illness
  • Other co-morbidity like terminal cancer.

Outcomes

Primary Outcomes

Sedentary time

Time Frame: 12 weeks follow-up

Time participants spend with sedentary behavior compared between the intervention and control group

Secondary Outcomes

  • The General Self-efficacy Scale (GSES)(Baseline,12 and 26 weeks follow-up)
  • Physical activity scale (PAS2)(Baseline,12 and 26 weeks follow-up)
  • The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire(Baseline,12 and 26 weeks follow-up)
  • The Fugl Meyer Assessment (FMA)(Baseline,12 and 26 weeks follow-up)
  • Montreal Cognitive Assessment (MoCA)(Baseline)
  • Patient health questionnaire (PHQ-9)(Baseline,12 and 26 weeks follow-up)
  • The Stroke Specific Quality of Life Scale (SS-QOL)(Baseline,12 and 26 weeks follow-up)
  • Timed Up & Go (TUG) test(Baseline,12 and 26 weeks follow-up)
  • Glycated hemoglobin (HbA1c)(Baseline,6,12 and 26 weeks follow-up)

Study Sites (1)

Loading locations...

Similar Trials