MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke

NCT05793177 | Recruiting DMC

• 1 other identifier: MONSS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Behavior; Physical Inactivity; Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• Sedentary time

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

  12 weeks follow-up

Secondary Outcomes (9)

• Physical activity scale (PAS2)

  Baseline,12 and 26 weeks follow-up

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

  Baseline,12 and 26 weeks follow-up

• The General Self-efficacy Scale (GSES)

  Baseline,12 and 26 weeks follow-up

• The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire

  Baseline,12 and 26 weeks follow-up

• Patient health questionnaire (PHQ-9)

  Baseline,12 and 26 weeks follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Everyday Life is Rehabilitation

Control

NO INTERVENTION

Interventions

Everyday Life is Rehabilitation BEHAVIORAL

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University hospital

Roskilde, 4000, Denmark

RECRUITING

Related 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.

  PMID: 36860816 BACKGROUND

MeSH Terms

Conditions

Stroke; Behavior; Sedentary Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Stefan S Bodilsen, MSPT

CONTACT

+4528401595; sbodi@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d. student, MSPT, PT

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: March 31, 2023
• Study Start: October 1, 2023
• Primary Completion: October 15, 2024
• Study Completion: December 31, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

DK (1)