Stroke, AcuteMONSSNCT05793177
MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
A study testing Everyday Life is Rehabilitation in people with Stroke, Acute and Behavior, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute, Behavior, Physical Inactivity
- What is being tested?
- Everyday Life is Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Aphasia
- Unable to give informed consent
- Unable to ambulate independently
- Mental illness
- Other co-morbidity like terminal cancer.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University hospital
Roskilde, 4000
Stefan S Bodilsen, +4528401595, sbodi@regionsjaelland.dk
About this study
Official title: 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.
- Conditions
- Stroke, Acute, Behavior, Physical Inactivity, Sedentary Behavior
- Being tested
- Everyday Life is Rehabilitation
- Medical subject headings
- Stroke, Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everyday Life is RehabilitationBehavioural
Behavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Everyday Life is Rehabilitation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary time
Time participants spend with sedentary behavior compared between the intervention and control group
Measured: 12 weeks follow-up
Secondary outcomes (9)
Physical activity scale (PAS2)
Subjective physical activity
Measured: Baseline,12 and 26 weeks follow-up
The Stroke Specific Quality of Life Scale (SS-QOL)
Quality of life
Measured: Baseline,12 and 26 weeks follow-up
The General Self-efficacy Scale (GSES)
self-efficacy
Measured: Baseline,12 and 26 weeks follow-up
The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire
Fatigue
Measured: Baseline,12 and 26 weeks follow-up
Patient health questionnaire (PHQ-9)
Depression symptoms
Measured: Baseline,12 and 26 weeks follow-up
The Fugl Meyer Assessment (FMA)
The function of upper and lower extremity
Measured: Baseline,12 and 26 weeks follow-up
Timed Up & Go (TUG) test
Mobility
Measured: Baseline,12 and 26 weeks follow-up
Montreal Cognitive Assessment (MoCA)
cognitive assessment
Measured: Baseline
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c)
Measured: Baseline,6,12 and 26 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Oct 2023
- Primary completion15 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Sjørslev Bodilsen, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793177
- Sponsor's protocol ID
- MONSS
- Acronym
- MONSS
- Status last verified
- Jul 2024
- First submitted
- 23 Mar 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36860816
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05793177
- Acronym / sponsor ID
- MONSS / MONSS
- Conditions
- Stroke, Acute, Behavior, Physical Inactivity, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Everyday Life is Rehabilitation |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Aphasia
- Unable to give informed consent
- Unable to ambulate independently
- Mental illness
- Other co-morbidity like terminal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everyday Life is RehabilitationBehavior change intervention focuses on implementing more movement into everyday life using action planning, goal setting, and fatigue management. | Behavioural | Intervention |
Primary outcome
Sedentary time
Time frame: 12 weeks follow-up
Time participants spend with sedentary behavior compared between the intervention and control group
9 secondary outcomes
Physical activity scale (PAS2)
Time frame: 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
The General Self-efficacy Scale (GSES)
Time frame: Baseline,12 and 26 weeks follow-up
The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire
Time frame: Baseline,12 and 26 weeks follow-up
Patient health questionnaire (PHQ-9)
Time frame: Baseline,12 and 26 weeks follow-up
The Fugl Meyer Assessment (FMA)
Time frame: Baseline,12 and 26 weeks follow-up
Timed Up & Go (TUG) test
Time frame: Baseline,12 and 26 weeks follow-up
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline
Glycated hemoglobin (HbA1c)
Time frame: Baseline,6,12 and 26 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 36860816Bodilsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everyday Life is Rehabilitation in people with Stroke, Acute and Behavior, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan S Bodilsen, MSPT (+4528401595, sbodi@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary time (time frame: 12 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.