MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

NCT ID: NCT05793177

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Stroke, Acute Behavior Physical Inactivity Sedentary Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Group Type EXPERIMENTAL

Everyday Life is Rehabilitation

Intervention Type BEHAVIORAL

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Everyday Life is Rehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stefan Sjørslev Bodilsen

Ph.d. student, MSPT, PT

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zealand University hospital

Roskilde, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Stefan S Bodilsen, MSPT

Role: CONTACT

+4528401595

Facility Contacts

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Stefan S Bodilsen

Role: primary

+4528401595

References

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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.

Reference Type BACKGROUND
PMID: 36860816 (View on PubMed)

Other Identifiers

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MONSS

Identifier Type: -

Identifier Source: org_study_id

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