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

• Sponsor: Zealand University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05793177
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 17

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute; Behavior; Physical Inactivity; Sedentary Behavior	Behavioral: Everyday Life is Rehabilitation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sedentary time [12 weeks follow-up]

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

Secondary Outcome Measures

1. Physical activity scale (PAS2) [Baseline,12 and 26 weeks follow-up]

   Subjective physical activity

2. The Stroke Specific Quality of Life Scale (SS-QOL) [Baseline,12 and 26 weeks follow-up]

   Quality of life

3. The General Self-efficacy Scale (GSES) [Baseline,12 and 26 weeks follow-up]

   self-efficacy

4. The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire [Baseline,12 and 26 weeks follow-up]

   Fatigue

5. Patient health questionnaire (PHQ-9) [Baseline,12 and 26 weeks follow-up]

   Depression symptoms

6. The Fugl Meyer Assessment (FMA) [Baseline,12 and 26 weeks follow-up]

   The function of upper and lower extremity

7. Timed Up & Go (TUG) test [Baseline,12 and 26 weeks follow-up]

   Mobility

8. Montreal Cognitive Assessment (MoCA) [Baseline]

   cognitive assessment

9. Glycated hemoglobin (HbA1c) [Baseline,6,12 and 26 weeks follow-up]

   Glycated hemoglobin (HbA1c)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zealand University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Stefan Sjørslev Bodilsen, Ph.d. student, MSPT, PT, Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT05793177
• Other Study ID Numbers: MONSS
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Mar 31, 2023