In-hospital MobilityNCT05926908
Hospital-Induced Immobility
An observational study of In-hospital Mobility and Geriatric, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Inactivity and bedrest during hospitalisation have numerous negative consequences, and it is especially important that older patients are mobile during hospitalisation. In this study the investigators aimed to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative could… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-hospital Mobility, Geriatric, Immobilization
- What is being tested?
- A Mobilisation Initiative, Focus Group Interviews and Formal Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 596 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the geriatric and medical wards at Copenhagen University Hospital, Rigshospitalet
Who may be able to join
- In-hospital patients in the geriatric and medical ward at Copenhagen University Hospital, Rigshospitalet
Who cannot join
- Patients declared moribund or delirious in the electronical medical journal
- Patients isolated in the hospital room
- Patients requiring interpreter for communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospital-Induced Immobility - A Backstage Story of Lack of Chairs, Time, and Assistance
Inactivity and bedrest during hospitalisation have numerous negative consequences, and it is especially important that older patients are mobile during hospitalisation. In this study the investigators aimed to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative could increase mobilisation of patients in a geriatric and a medical ward. Furthermore, the investigators wanted to explore patients' and health care staffs' view on facilitators and barriers for mobilisation during hospitalisation
Read the detailed description
Staying in bed and being inactive during hospitalisation can lead to a range of adverse consequences especially among older adults. The consequences include loss of muscle mass and strength leading to problems with loss of functional independence, risk of re-hospitalisation, and death. Moreover, older adults do not recover as well as younger adults with poor long-term recovery. The lack of in-hospital mobilisation is due to several factors including the hospital culture and organisational factors. Therefore, it is necessary to bring attention to this problem among the hospital staff. The aim of this study is to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative can increase the number of patients mobilised for breakfast and lunch among patients admitted to geriatric and medical wards. The activities planned in this study is self-reported level of mealtime mobilisation and observations of the patients, focus group interviews and survey on mobilisation awareness among the clinical staff, introduction of formal education and a Mobilisation Initiative. As hypothesized, this will result in an increased awareness of in-hospital mobilisation leading to an increase in the number of patients mobilised at mealtimes. Accordingly, expectations are that this will affect the activity level of the hospitalised patients and reduce adverse consequences leading to an increase in functional independence and reduce the number of readmissions resulting in a socioeconomic benefit.
- Conditions
- In-hospital Mobility, Geriatric, Immobilization
- Being tested
- A Mobilisation Initiative, Focus Group Interviews, Formal Education, Self-reported Level of Mobilisation, Observations of Patients and the Environment
- Keywords
- Mobilisation, Rehabilitation, older adults, inactivity, hospitalisation
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Mobilisation InitiativeBehavioural
The Mobilisation Initiative consists of physiotherapists assisting nursing staff in mobilising patients to sit in a chair for breakfast and lunch. This intervention follows the interventions of focus group interviews, formal education, observations of patients and the environment, and awareness of mobilisation survey
Focus Group InterviewsBehavioural
Focus group interviews using a semi-structured interview guide are conducted with health care professionals at the wards to explore the acceptability and demand for the contents of the Mobilisation Initiative, including the identification of facilitators and barriers to mobilisation
Formal EducationBehavioural
Formal education for all nursing staff employed at the two wards includes information on the consequences of immobilisation, with the purpose of enhancing confidence, competencies, and awareness of mobilisation
Self-reported Level of MobilisationBehavioural
Patient's self-reported mealtime mobilisation level reported through interview-based surveys, including structured follow-up questions
Observations of Patients and the EnvironmentBehavioural
During breakfast and lunch, the mobilisation status of all patients in the wards is observed using an observation checklist
Awareness of Mobilisation SurveyBehavioural
To assess the nursing staff's awareness of and confidence in the mobilisation of the patients, a short survey on mobilisation awareness is distributed to the nursing staff at both wards
| Study group | Role | What they receive |
|---|---|---|
| Geriatric ward | Interventions are: Patients' self-reported level of mealtime mobilisation, observations of the patients' mobilisation level and environment at mealtimes, focus group interviews with health care professionals at the wards, survey on mobilisation awareness among the nursing staff, a Mobilisation Initiative, and formal education for all nursing staff Receives: Behavioral: A Mobilisation Initiative; Behavioral: Focus Group Interviews; Behavioral: Formal Education; Behavioral: Self-reported Level of Mobilisation; Behavioral: Observations of Patients and the Environment; Behavioral: Awareness of Mobilisation Survey | |
| Medical ward | Interventions are: Patients' self-reported level of mealtime mobilisation, observations of the patients' mobilisation level and environment at mealtimes, focus group interviews with health care professionals at the wards, survey on mobilisation awareness among the nursing staff, a Mobilisation Initiative, and formal education for all nursing staff Receives: Behavioral: A Mobilisation Initiative; Behavioral: Focus Group Interviews; Behavioral: Formal Education; Behavioral: Self-reported Level of Mobilisation; Behavioral: Observations of Patients and the Environment; Behavioral: Awareness of Mobilisation Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patients mobilised at lunch
Change in percentage of patients mobilised at lunch t0-t1 Change in percentage of patients mobilised at lunch t1-t2 Change in percentage of patients mobilised at lunch t2-t3 Change in percentage of patients mobilised at lunch t3-t4 Change in percentage of patients mobilised at lunch t4-t5 Change in percentage of patients mobilised at lunch t5-t6
Measured: One, two, three, four, five, and six months
Change in patients mobilised at breakfast
Change in percentage of patients mobilised at breakfast t0-t1 Change in percentage of patients mobilised at breakfast t1-t2 Change in percentage of patients mobilised at breakfast t2-t3 Change in percentage of patients mobilised at breakfast t3-t4 Change in percentage of patients mobilised at breakfast t4-t5 Change in percentage of patients mobilised at breakfast t5-t6
Measured: One, two, three, four, five, and six months
Secondary outcomes (7)
Change in chairs present bedside at breakfast
Change in percentage of chairs observed placed bedside at breakfast for each patient t1-t2 Change in percentage of chairs observed placed bedside at breakfast for each patient t2-t3 Change in percentage of chairs observed placed bedside at breakfast for each patient t3-t4 Change in percentage of chairs observed placed bedside at breakfast for each patient t4-t5 Change in percentage of chairs observed placed bedside at breakfast for each patient t5-t6
Measured: Two, three, four, five, and six months
Change in chairs present bedside at lunch
Change in percentage of chairs observed placed bedside at lunch for each patient t1-t2 Change in percentage of chairs observed placed bedside at lunch for each patient t2-t3 Change in percentage of chairs observed placed bedside at lunch for each patient t3-t4 Change in percentage of chairs observed placed bedside at lunch for each patient t4-t5 Change in percentage of chairs observed placed bedside at lunch for each patient t5-t6
Measured: Two, three, four, five, and six months
Self-reported level of mobilisation
Level of patient's mealtime mobilisation level reported through interview-based surveys on a 5-item ordinal scale: independently, with supervision, with the physical help of one person, with the physical help of two persons, or never sit in a chair.
Measured: One and six months
The Mobilisation Initiative
The utilisation of the Mobilisation Initiative recorded as the daily number of patients referred to and mobilised in the Mobilisation Initiative at each ward
Measured: One and six months
Formal Education
The number of nursing staff attending formal education
Measured: Four and five months
Focus Group Interviews
Description of facilitators and barriers for mobilising the patients at each ward
Measured: Two months
Awareness of mobilisation among the nursing staff
Levels of awareness on mobilisation among the nursing staff at each ward reported through questionnaires including the questions: "Do you feel confident mobilising your patients to sit in a chair at mealtimes?," "To what degree do you feel prepared to do a safe transfer from the bed to a chair with a patient you do not know?," and "How often do you talk to your colleagues about mobilisation?". Questions are answered on 5-item Likert scales: never, less than half of the time, half of the time, more than half of the time, and every time; and to a very low degree, to a low degree, neither/nor, to a high degree, and to a very high degree
Measured: Two months and follow up at eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Apr 2021
- Primary completion1 Oct 2021
- Study completion31 Dec 2021
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 In-hospital MobilityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Christensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926908
- Sponsor's protocol ID
- P-2020-1173
- Status last verified
- Apr 2025
- First submitted
- 12 Jun 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piper KS, Oxfeldt M, Pedersen MM, Christensen J. Hospital-induced immobility - a backstage story of lack of chairs, time, and assistance. BMC Geriatr. 2024 Aug 24;24(1):704. doi: 10.1186/s12877-024-05286-6.
PubMed 39182057
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-Induced Immobility - A Backstage Story of Lack of Chairs, Time, and Assistance
- ClinicalTrials.gov ID
- NCT05926908
- Acronym / sponsor ID
- P-2020-1173
- Conditions
- In-hospital Mobility, Geriatric, Immobilization
- Keywords
- Mobilisation, Rehabilitation, older adults, inactivity, hospitalisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Jul 2023 (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.
Inactivity and bedrest during hospitalisation have numerous negative consequences, and it is especially important that older patients are mobile during hospitalisation. In this study the investigators aimed to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative could increase mobilisation of patients in a geriatric and a medical ward. Furthermore, the investigators wanted to explore patients' and health care staffs' view on facilitators and barriers for mobilisation during hospitalisation
Detailed description
Staying in bed and being inactive during hospitalisation can lead to a range of adverse consequences especially among older adults. The consequences include loss of muscle mass and strength leading to problems with loss of functional independence, risk of re-hospitalisation, and death. Moreover, older adults do not recover as well as younger adults with poor long-term recovery. The lack of in-hospital mobilisation is due to several factors including the hospital culture and organisational factors. Therefore, it is necessary to bring attention to this problem among the hospital staff. The aim of this study is to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative can increase the number of patients mobilised for breakfast and lunch among patients admitted to geriatric and medical wards. The activities planned in this study is self-reported level of mealtime mobilisation and observations of the patients, focus group interviews and survey on mobilisation awareness among the clinical staff, introduction of formal education and a Mobilisation Initiative. As hypothesized, this will result in an increased awareness of in-hospital mobilisation leading to an increase in the number of patients mobilised at mealtimes. Accordingly, expectations are that this will affect the activity level of the hospitalised patients and reduce adverse consequences leading to an increase in functional independence and reduce the number of readmissions resulting in a socioeconomic benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geriatric ward | – | Behavioral: A Mobilisation Initiative, Behavioral: Focus Group Interviews, Behavioral: Formal Education, Behavioral: Self-reported Level of Mobilisation, Behavioral: Observations of Patients and the Environment, Behavioral: Awareness of Mobilisation SurveyInterventions are: Patients' self-reported level of mealtime mobilisation, observations of the patients' mobilisation level and environment at mealtimes, focus group interviews with health care professionals at the wards, survey on mobilisation awareness among the nursing staff, a Mobilisation Initiative, and formal education for all nursing staff |
| Medical ward | – | Behavioral: A Mobilisation Initiative, Behavioral: Focus Group Interviews, Behavioral: Formal Education, Behavioral: Self-reported Level of Mobilisation, Behavioral: Observations of Patients and the Environment, Behavioral: Awareness of Mobilisation SurveyInterventions are: Patients' self-reported level of mealtime mobilisation, observations of the patients' mobilisation level and environment at mealtimes, focus group interviews with health care professionals at the wards, survey on mobilisation awareness among the nursing staff, a Mobilisation Initiative, and formal education for all nursing staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the geriatric and medical wards at Copenhagen University Hospital, Rigshospitalet
Key inclusion criteria (1 listed)
- In-hospital patients in the geriatric and medical ward at Copenhagen University Hospital, Rigshospitalet
Key exclusion criteria (3 listed)
- Patients declared moribund or delirious in the electronical medical journal
- Patients isolated in the hospital room
- Patients requiring interpreter for communication
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 |
|---|---|---|
| A Mobilisation InitiativeThe Mobilisation Initiative consists of physiotherapists assisting nursing staff in mobilising patients to sit in a chair for breakfast and lunch. This intervention follows the interventions of focus group interviews, formal education, observations of patients and the environment, and awareness of mobilisation survey | Behavioural | Geriatric ward, Medical ward |
| Focus Group InterviewsFocus group interviews using a semi-structured interview guide are conducted with health care professionals at the wards to explore the acceptability and demand for the contents of the Mobilisation Initiative, including the identification of facilitators and barriers to mobilisation | Behavioural | Geriatric ward, Medical ward |
| Formal EducationFormal education for all nursing staff employed at the two wards includes information on the consequences of immobilisation, with the purpose of enhancing confidence, competencies, and awareness of mobilisation | Behavioural | Geriatric ward, Medical ward |
| Self-reported Level of MobilisationPatient's self-reported mealtime mobilisation level reported through interview-based surveys, including structured follow-up questions | Behavioural | Geriatric ward, Medical ward |
| Observations of Patients and the EnvironmentDuring breakfast and lunch, the mobilisation status of all patients in the wards is observed using an observation checklist | Behavioural | Geriatric ward, Medical ward |
| Awareness of Mobilisation SurveyTo assess the nursing staff's awareness of and confidence in the mobilisation of the patients, a short survey on mobilisation awareness is distributed to the nursing staff at both wards | Behavioural | Geriatric ward, Medical ward |
Primary outcome
Change in patients mobilised at lunch
Time frame: One, two, three, four, five, and six months
Change in percentage of patients mobilised at lunch t0-t1 Change in percentage of patients mobilised at lunch t1-t2 Change in percentage of patients mobilised at lunch t2-t3 Change in percentage of patients mobilised at lunch t3-t4 Change in percentage of patients mobilised at lunch t4-t5 Change in percentage of patients mobilised at lunch t5-t6
Change in patients mobilised at breakfast
Time frame: One, two, three, four, five, and six months
Change in percentage of patients mobilised at breakfast t0-t1 Change in percentage of patients mobilised at breakfast t1-t2 Change in percentage of patients mobilised at breakfast t2-t3 Change in percentage of patients mobilised at breakfast t3-t4 Change in percentage of patients mobilised at breakfast t4-t5 Change in percentage of patients mobilised at breakfast t5-t6
7 secondary outcomes
Change in chairs present bedside at breakfast
Time frame: Two, three, four, five, and six months
Change in chairs present bedside at lunch
Time frame: Two, three, four, five, and six months
Self-reported level of mobilisation
Time frame: One and six months
The Mobilisation Initiative
Time frame: One and six months
Formal Education
Time frame: Four and five months
Focus Group Interviews
Time frame: Two months
Awareness of mobilisation among the nursing staff
Time frame: Two months and follow up at eight months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 39182057Piper KS, Oxfeldt M, Pedersen MM, Christensen J. Hospital-induced immobility - a backstage story of lack of chairs, time, and assistance. BMC Geriatr. 2024 Aug 24;24(1):704. doi: 10.1186/s12877-024-05286-6.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-hospital Mobility and Geriatric, run by Copenhagen University Hospital, Rigshospitalet 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 6 Apr 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in patients mobilised at lunch (time frame: One, two, three, four, five, and six months). The study lists 2 primary outcomes in all. 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 NCT05926908, 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 6 Apr 2025.