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NCT Number: NCT05793177

MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

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.

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Key information

Conditions

Stroke, Acute Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Physical Inactivity Sedentary Behavior Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zealand University hospital

Roskilde, 4000, Denmark

Location status: Recruiting

Location contact

Stefan S Bodilsen

CONTACT

[email protected]

+4528401595

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Everyday Life is Rehabilitation

Behavioral

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

Primary outcomes

  1. Sedentary time

    Time frame: 12 weeks follow-up

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

Secondary outcomes

  1. Physical activity scale (PAS2)

    Time frame: Baseline,12 and 26 weeks follow-up

    Subjective physical activity

  2. The Stroke Specific Quality of Life Scale (SS-QOL)

    Time frame: Baseline,12 and 26 weeks follow-up

    Quality of life

  3. The General Self-efficacy Scale (GSES)

    Time frame: Baseline,12 and 26 weeks follow-up

    self-efficacy

  4. The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire

    Time frame: Baseline,12 and 26 weeks follow-up

    Fatigue

  5. Patient health questionnaire (PHQ-9)

    Time frame: Baseline,12 and 26 weeks follow-up

    Depression symptoms

  6. The Fugl Meyer Assessment (FMA)

    Time frame: Baseline,12 and 26 weeks follow-up

    The function of upper and lower extremity

  7. Timed Up & Go (TUG) test

    Time frame: Baseline,12 and 26 weeks follow-up

    Mobility

  8. Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline

    cognitive assessment

  9. Glycated hemoglobin (HbA1c)

    Time frame: Baseline,6,12 and 26 weeks follow-up

    Glycated hemoglobin (HbA1c)

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan S Bodilsen, MSPT

CONTACT

[email protected]

+4528401595

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Acronym: MONSS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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