The WALK-Copenhagen Trial (WALK-Cph): a Mixed Methods Study

Hospitalization Clinical Trial

Official title:

WALK-Copenhagen (WALK-Cph): Promoting Physical Activity in Older Adults During Hospitalization and After Discharge

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03825497
• Other study ID #: H-18027877
• Status: Terminated
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activity
• Hospitalization

Intervention

Other:
• Promotion of activity during and after hospitalization
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

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Hvidovre	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	Danske Fysioterapeuter, Velux Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of steps measured by an ActivPal (PAL Technologies Ltd) activity monitor	Between group difference in number of steps per day	Mean number of steps per day during hospitalization (up to 7 days)
Secondary	Time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor	Between group difference time spent lying/sitting per day	Mean number of hours per day spent lying/sitting during hospitalization (up to 7 days)
Secondary	Change in upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor	Between group difference in change in time spent standing or walking per day (Upright time)	Change in mean number of hours per day spent upright between hospitalization and 4 weeks after discharge
Secondary	Change in number of steps measured by an ActivPal (PAL Technologies Ltd)activity monitor	between group difference in change in number of steps per day	Change in mean number of steps per day between hospitalization and 4 weeks after discharge
Secondary	Change in time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor	Between group difference in change in time spent lying/sitting per day	Change in mean number of hours per day spent lying/sitting between hospitalization and 4 weeks after discharge
Secondary	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)	Between group difference in change in Life Space	Change in Life Space between admission and 4 weeks after discharge
Secondary	Change in 4-meter gait speed test	Between group in change in Habitual gait speed	Change in habitual gait speed between admission and 4 weeks after discharge
Secondary	Change in mobility using The de Morton Mobility Index (DEMMI) (0-100 point scale with 0 representing low mobility and 100 representing high mobility)	Between group difference in change in mobility	Change in DEMMI score between admission and 4 weeks after discharge

External Links

•   A tailored strategy for designing the Walk-Copenhagen (WALK-Cph) intervention to increase mobility in hospitalised older medical patients: a protocol for the qualitative part of the WALK-Cph project