Clinical trial NCT06983977: Increasing Physical Activity Among Medical Inpatients by Digital Nudging of Patients and Staff
Official title: Increasing Physical Activity Among Medical Inpatients by Digital Nudging of Patients and Staff - A Cluster Randomised Multicentre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Activity
Inpatients
Digital Health
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sedentary behaviour among medical inpatients is strongly associated with hospital-associated functional decline and poses a severe threat to patients' functional capacity and independency. High human and socioeconomic costs underline the urgency to find solutions to this world-wide problem.

Objective: This multicentre study, including a total of 400 patients from Copenhagen, Aalborg, Tórshavn, and Nuuk, will assess the effect of a digital intervention that aims to reduce sedentary behaviour and increase physical activity in medical inpatients.

Intervention: Digital feedback and nudging regarding the patients' physical activity levels to patients and healthcare staff Design: Stepped-wedge cluster randomised multicentre trial Primary outcome: Daily average time of patients' physical activity (minutes).


Eligibility criteria: Inclusion Criteria:

* Admitted to one of the participating wards
* Has understood and signed informed consent
* Reads and understands Danish, Faroese, Greenlandic or English

Exclusion Criteria:

* Has an expected hospitalisation less than 24 hours after potential recruitment
* Is not able to give informed consent to participate in the study
* Has allergy towards band aid
* Not able to (shortly) stand in an upright position even with maximal assistance
* There are contraindications for the patient to mobilise or be physically active due to unstabilized acute medical conditions, including, but not limited to, acute aortic dissection, -myocardial infarction, -pulmonary embolism, -sepsis.
* There are ethical concerns regarding the patients' participation in the study, including, but not limited to, the patient being:

  * In the terminal phase of life
  * In a crisis state regarding their disease/situation and deemed unfit for participation

To ensure medically responsible inclusion of patients, the project personnel will consult and confer with the treatment responsible medical doctor, or their delegate, before including a potential participant for the trial.

Primary outcomes:
measure: Daily average time of participants' physical activity (minutes)
timeFrame: From enrollment to end of trial participation (maximum 7 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Region Hovedstaden
city: Hobro
country: Denmark
facility: Aalborg University Hospital
state: Region Nordjylland
city: Tórshavn
country: Faroe Islands
facility: National Hospital
city: Nuuk
country: Greenland
facility: Queen Ingrids Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Christian H Dall, Associate professor, PhD
role: PRINCIPAL_INVESTIGATOR
References: