NCT03825497

Brief Summary

The WALK-Copenhagen project aims at enhancing physical activity during and after hospitalization in older medical patients by an intervention developed in co-operation with key stakeholders

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

October 5, 2018

Last Update Submit

November 20, 2019

Conditions

Keywords

older medical patientmobilityhospitalizationactivity monitoringcross sectoral

Outcome Measures

Primary Outcomes (1)

  • Upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor

    Between group difference in time spent standing or walking per day (Upright time)

    Mean number of hours per day spent upright during hospitalization (up to 7 days)

Secondary Outcomes (8)

  • Number of steps measured by an ActivPal (PAL Technologies Ltd) activity monitor

    Mean number of steps per day during hospitalization (up to 7 days)

  • Time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor

    Mean number of hours per day spent lying/sitting during hospitalization (up to 7 days)

  • Change in upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor

    Change in mean number of hours per day spent upright between hospitalization and 4 weeks after discharge

  • Change in number of steps measured by an ActivPal (PAL Technologies Ltd)activity monitor

    Change in mean number of steps per day between hospitalization and 4 weeks after discharge

  • Change in time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor

    Change in mean number of hours per day spent lying/sitting between hospitalization and 4 weeks after discharge

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

1\) On admission, patients will receive a welcome folder focusing on physical activity; 2) daily during hospitalization, patients will be encouraged to walk along a walk path in the hallway; 3) during hospitalization, patients will be encouraged to consult and use posters with exercises (sit to stand, heel raise, balance); 4) on admission, patients will receive a prescribed walk plan with 3 daily walking sessions to perform during hospitalization (3 times 1 minute, 5 minutes or 10 minutes); 5) during hospitalization patients will be motivated to pick up of clothes and beverages themselves; 6) patients will be discharged with a walk plan to use at home; 7) after discharge the municipality will follow up on patients receiving home care and patients with a rehabilitation plan

Other: Promotion of activity during and after hospitalization

Usual care

NO INTERVENTION

All patients admitted to the control wards will receive usual care during and after hospitalization.

Interventions

1\) a welcome folder encouraging physical activity; 2) encouragement to use a walk path established in the ward; 3) encouragement to use posters containing exercise suggestions;4) prescription of a walk-plan for in-hospital use; 5) encouragement to pick up clothes and beverages by oneself; 6) prescription of a walk-plan at discharge for at home use 7) follow-up on walk plan after discharge by municipality

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • +65 years
  • acutely admitted to intervention wards
  • able to walk independently with or without walking aid

You may not qualify if:

  • in isolation
  • inability to cooperate
  • not able to speak or understand Danish
  • in treatment for cancer
  • terminally ill
  • transferred to intensive care unit or another ward within 24 hours after admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Pedersen BS, Kirk JW, Olesen MK, Gronfeldt BM, Stefansdottir NT, Brodsgaard R, Tjornhoj-Thomsen T, Nilsen P, Andersen O, Bandholm T, Pedersen MM. Feasibility and implementation fidelity of a co-designed intervention to promote in-hospital mobility among older medical patients-the WALK-Copenhagen project (WALK-Cph). Pilot Feasibility Stud. 2022 Apr 9;8(1):80. doi: 10.1186/s40814-022-01033-z.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mette M Pedersen, PhD

    Postdoc, Clinical Research Centre, Hvidovre Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
All patients at the intervention wards will receive the intervention why neither investigators nor outcome assessors will be blinded to the intervention. Patients at intervention and control wards will get equal information regarding the study and will be asked to participate in equal assessments
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A feasibility study at Medical Wards (intervention wards) in Oct 2018, January 2019 and February 2019 prior to a cluster randomized trial. Medical wards at 4 different hospitals representing clusters - 2 intervention clusters and 2 control clusters.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

October 5, 2018

First Posted

January 31, 2019

Study Start

September 25, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations