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

November 20, 2019 updated by: Mette Merete Pedersen, Copenhagen University Hospital, Hvidovre

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital, Hvidovre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
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
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
NO_INTERVENTION: Usual care
All patients admitted to the control wards will receive usual care during and after hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor
Time Frame: Mean number of hours per day spent upright during hospitalization (up to 7 days)
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Collaborators

Velux Fonden
Danske Fysioterapeuter

Investigators

  • Principal Investigator: Mette M Pedersen, PhD, Postdoc, Clinical Research Centre, Hvidovre Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 25, 2018

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

January 30, 2019

First Posted (ACTUAL)

January 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-18027877

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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