MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke (MONSS)

March 30, 2023 updated by: Stefan Sjørslev Bodilsen, Zealand University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Everyday Life is Rehabilitation
Behavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedentary time
Time Frame: 12 weeks follow-up
Time participants spend with sedentary behavior compared between the intervention and control group
12 weeks follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2023

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MONSS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke, Acute

Clinical Trials on Everyday Life is Rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe