HospitalizationNCT03825497
The WALK-Copenhagen Trial (WALK-Cph): a Mixed Methods Study
A study testing Promotion of activity during and after hospitalization in people with Hospitalization and Activity, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hospitalization, Activity
- What is being tested?
- Promotion of activity during and after hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Sep 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- +65 years
- acutely admitted to intervention wards
- able to walk independently with or without walking aid
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Hospitalization, Activity
- Being tested
- Promotion of activity during and after hospitalization
- Keywords
- older medical patient, mobility, hospitalization, activity monitoring, cross sectoral
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of activity during and after hospitalizationOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor
Between group difference in time spent standing or walking per day (Upright time)
Measured: 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
Between group difference in number of steps per day
Measured: 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
Between group difference time spent lying/sitting per day
Measured: 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
Between group difference in change in time spent standing or walking per day (Upright time)
Measured: 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
between group difference in change in number of steps per day
Measured: 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
Between group difference in change in time spent lying/sitting per day
Measured: 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)
Between group difference in change in Life Space
Measured: Change in Life Space between admission and 4 weeks after discharge
Change in 4-meter gait speed test
Between group in change in Habitual gait speed
Measured: 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)
Between group difference in change in mobility
Measured: Change in DEMMI score between admission and 4 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start25 Sep 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, Danske Fysioterapeuter
- Responsible party
- Principal investigator, Mette Merete Pedersen, Copenhagen University Hospital, Hvidovre
- Investigators
- Mette M Pedersen, PhD, Principal investigator, Postdoc, Clinical Research Centre, Hvidovre Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825497
- Sponsor's protocol ID
- H-18027877
- Status last verified
- Nov 2019
- First submitted
- 5 Oct 2018
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35397574
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WALK-Copenhagen (WALK-Cph): Promoting Physical Activity in Older Adults During Hospitalization and After Discharge
- ClinicalTrials.gov ID
- NCT03825497
- Acronym / sponsor ID
- H-18027877
- Conditions
- Hospitalization, Activity
- Keywords
- older medical patient, mobility, hospitalization, activity monitoring, cross sectoral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Velux Fonden, Danske Fysioterapeuter
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Promotion of activity during and after hospitalization1) 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 |
| Usual care | No intervention | –All patients admitted to the control wards will receive usual care during and after hospitalization. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- +65 years
- acutely admitted to intervention wards
- able to walk independently with or without walking aid
Key exclusion criteria (6 listed)
- in isolation
- inability to cooperate
- not able to speak or understand Danish
- in treatment for cancer
- terminally ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promotion of activity during and after hospitalization1) 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 | Other | Intervention |
Primary outcome
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)
8 secondary outcomes
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)
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)
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
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
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
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
Change in 4-meter gait speed test
Time frame: 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
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 35397574Pedersen 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.
- 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 projectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette M Pedersen, PhD principal investigator
Postdoc, Clinical Research Centre, Hvidovre Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of activity during and after hospitalization in people with Hospitalization and Activity, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03825497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.