NCT06983977

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
May 2025Dec 2027

First Submitted

Initial submission to the registry

May 14, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

May 19, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 14, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daily average time of participants' physical activity (minutes)

    From enrollment to end of trial participation (maximum 7 days)

Study Arms (2)

Control

OTHER

Measurement of physical activity

Other: Measurement of physical activity

Intervention

EXPERIMENTAL

Digital feedback and nudging to participant and staff regarding participants' physical activity levels

Other: Digital nudging

Interventions

Measurement of physical activity by accelerometer

Control

Digital feedback and nudging to participants (patients) and staff, based on participants' physical activity measurements, aiming to increase patients' physical activity and reduce sedentary time

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bispebjerg Hospital

Copenhagen, Capital Region, Denmark

RECRUITING

Aalborg University Hospital

Hobro, North Denmark, Denmark

RECRUITING

National Hospital

Tórshavn, Faroe Islands

RECRUITING

Queen Ingrids Hospital

Nuuk, Greenland

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christian H Dall, Associate professor, PhD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Durita V Gunnarsson, PhD student, MSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

May 19, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations