Clinical trial NCT03825497: The WALK-Copenhagen Trial (WALK-Cph): a Mixed Methods Study
Official title: WALK-Copenhagen (WALK-Cph): Promoting Physical Activity in Older Adults During Hospitalization and After Discharge
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hospitalization
Activity
Keywords: older medical patient
mobility
hospitalization
activity monitoring
cross sectoral
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: Danske Fysioterapeuter
First posted: 2019-01-31
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed description: In four phases we will develop (Phase 1), fidelity- and feasibility test (Phase 2), efficacy test (Phase 3) and adoption test the intervention (Phase 4). The project will use a combination of qualitative (Phase 1-4) and quantitative methods (Phase 2-3) and consists of two parallel tracks - WALK-Intervention and WALK-Implementation. Phase 1 of the study has been completed. Through workshops with patients, relatives, health professionals and researchers we have developped an intervention to enhance physical activity. Phase 2 will be carried out in October 2018 and January 2019 at Copenhagen University Hospital Hvidovre and in February 2019 at Copenhagen University Hospital, Frederiksberg. The developed intervention will be fidelity tested through daily observations at the wards. Also, the intervention will be feasibility tested in a prospective cohort study aiming at qualifying the intervention, testing recruitment strategies, testing patient willingness towards the intervention, testing randomization and blinding procedures and estimating an inclusion rate for Phase 3 (randomized controlled trial) to be conducted in 2019.

Update March 2019:

Due to a political decision to close down the medical ward at Copenhagen University Hospital, Frederiksberg in the spring of 2019, it was decided to change Phase 3 to a cohort study at Copenhagen University Hospital, Hvidovre. This decision was based on the fact that the methodological setup of the study (cluster RCT) was unintentionally changed due to the close down of one of the intervention wards.

Update November 2019:

Due to changes in characteristics of patients admitted to the intervention ward and thus a very slow inclusion rate in Phase 3 (Cohort Study), it was decided to terminate inclusion of patients. Qualitative data will still be collected as anticipated.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor
timeFrame: Mean number of hours per day spent upright during hospitalization (up to 7 days)
Secondary outcomes:
measure: Number of steps measured by an ActivPal (PAL Technologies Ltd) activity monitor
timeFrame: Mean number of steps per day during hospitalization (up to 7 days)
measure: Time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor
timeFrame: Mean number of hours per day spent lying/sitting during hospitalization (up to 7 days)
measure: Change in upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor
timeFrame: Change in mean number of hours per day spent upright between hospitalization and 4 weeks after discharge
measure: Change in number of steps measured by an ActivPal (PAL Technologies Ltd)activity monitor
timeFrame: Change in mean number of steps per day between hospitalization and 4 weeks after discharge
measure: Change in time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor
timeFrame: Change in mean number of hours per day spent lying/sitting between hospitalization and 4 weeks after discharge
measure: Change in Life-Space mobility using The University of Alabama at Birmingham (UAB) Life Space Assessment (a 0-120 point scale with 0 representing low mobility and 120 high mobility)
timeFrame: Change in Life Space between admission and 4 weeks after discharge
measure: Change in 4-meter gait speed test
timeFrame: Change in habitual gait speed between admission and 4 weeks after discharge
measure: Change in mobility using The de Morton Mobility Index (DEMMI) (0-100 point scale with 0 representing low mobility and 100 representing high mobility)
timeFrame: Change in DEMMI score between admission and 4 weeks after discharge
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
Study officials:
affiliation: Postdoc, Clinical Research Centre, Hvidovre Hospital, Denmark
name: Mette M Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.