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Acute DiseaseNCT07830381

Physical Activity During Hospitalization and Hospital-Associated Disability

An observational study of Acute Disease and Old Age, run by Hvidovre University Hospital at 1 site in Denmark.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study examines physical activity during and after hospitalization in acutely hospitalized older adults and its association with hospital-associated disability (HAD). Older adults have low levels of physical activity during acute hospitalization, which is associated with an increased risk of HAD. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Acute Disease, Old Age, Geriatric
What is being tested?
Physical Activity During and After Hospitalization
How many people
170 participants
Where
1 siteDenmark
Study dates
Sep 2026to May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Older adults (65 years or older) acutely admitted to the Department of Geriatrics or the Department of Cardiology at Copenhagen University Hospital, Hvidovre.

Who may be able to join

  • Aged 65 years or older
  • Acutely admitted to the Department of Geriatrics or the Department of Cardiology

Who cannot join

  • In isolation
  • Delirium
  • Unable to provide informed consent
  • Unable to speak and understand Danish
  • Unable to take one step

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lea Kromann Etzerodt, MHSc contact

+4538620210

lea.kromann.johansen.01@regionh.dk

Mette Merete Pedersen, PhD contact

+4538623350

mette.merete.pedersen@regionh.dk

Denmark1 site
  • Copenhagen University Hospital, Hvidovre

    Hvidovre

    Lea Kromann Etzerodt, MHSc, +4538620210, lea.kromann.johansen.01@regionh.dk

Other trials in Denmark

About this study

Official title: Physical Activity as Prevention of Hospital-Associated Disability in Acutely Hospitalized Older Adults - How Much is Enough and What do the Patients Prefer?

This study examines physical activity during and after hospitalization in acutely hospitalized older adults and its association with hospital-associated disability (HAD).

Older adults have low levels of physical activity during acute hospitalization, which is associated with an increased risk of HAD. HAD is a decline in the ability to perform activities of daily living that occurs in relation to hospitalization and cannot be explained by the acute illness alone. HAD affects up to 30% of acutely hospitalized older adults and is associated with adverse outcomes, including an increased risk of discharge to a nursing home, readmission, and mortality. Furthermore, patients who develop HAD are at risk of not regaining their pre-admission functional level and experiencing persistent functional decline after discharge.

Read more

Physical activity and exercise are recommended as strategies to prevent HAD. However, many acutely hospitalized older adults have limited capacity or motivation to engage in structured exercise. It therefore remains unclear how much physical activity during hospitalization is sufficient to reduce the risk of HAD and which types of physical activity patients are able and prefer to perform. The study will also examine patients' ability and preferences for different types of physical activity during hospitalization and explore their motivation, barriers, and preferences for physical activity after discharge.

The results may help identify clinically relevant levels of physical activity during hospitalization and contribute to more patient-centered approaches to supporting physical activity and preventing functional decline during and after hospitalization.

Read the detailed description

This study is a prospective cohort study investigating physical activity, functioning, and hospital-associated disability (HAD) in acutely hospitalized older adults. The study also examines patients' ability, preferences, motivation, and barriers related to physical activity during hospitalization and after discharge.

Physical activity levels are generally low among older adults during acute hospitalization and are associated with an increased risk of HAD. Physical activity and exercise are recommended as strategies to prevent functional decline during hospitalization. However, there is currently no clear threshold for how much physical activity is needed to reduce the risk of HAD. Furthermore, many acutely hospitalized older adults have limited capacity or motivation to engage in structured exercise, highlighting the need to understand which forms and levels of physical activity are both clinically relevant and feasible from the patients' perspective.

The study will include 170 adults aged 65 years or older who are acutely admitted to the Department of Geriatrics or the Department of Cardiology at Copenhagen University Hospital - Hvidovre. Participants will be consecutively recruited within 48 hours of admission and followed during hospitalization and at 1, 4, and 8 weeks after discharge.

During hospitalization:

At inclusion, participants will undergo a baseline assessment consisting of clinical tests and questionnaires assessing functioning, mobility, frailty, health literacy, general health, physical activity, and demographic characteristics.

24-hour physical activity will be objectively measured using SENS motion® sensor technology. The sensor will be worn continuously during hospitalization and will provide information on daily step count and time spent walking, standing, sitting, and lying down. Self-reported mobility during hospitalization will additionally be assessed using the Danish version of the Acute Care Mobility Assessment (ACMA-DK).

During hospitalization participants' imagined and actual ability to perform different forms of physical activity will also be assessed, together with their preferences, motivation, and barriers related to physical activity. Participants will be asked to evaluate and perform two clinically relevant activity types: hallway walking and resistance exercise. They will also be asked about their preference for group-based functional training.

1 week after discharge: Participants will be contacted by telephone to assess functioning and the development of HAD following hospitalization.

4 weeks after discharge: Participants will be contacted by telephone to reassess functioning and whether functional decline following hospitalization persists.

8 weeks after discharge: An 8-week follow-up assessment will be conducted in the participant's home. Physical activity after discharge will be objectively measured using SENS motion® sensor technology for seven consecutive days prior to the 8-week follow-up. At the follow-up visit, physical function, mobility, and the development or persistence of HAD will be assessed.

A qualitative study is embedded within the prospective cohort to explore patients' experiences and perspectives on physical activity after discharge. Participants will be recruited among patients who have completed the 8-week follow-up. Semi-structured interviews will explore motivation, barriers, and preferences related to physical activity after discharge, as well as experiences with rehabilitation.

The overall aim of the project is to integrate objectively measured physical activity patterns, clinical measures of functioning, and patients' own experiences and preferences to contribute to the development of a practice-oriented and patient-centered approach to preventing HAD in acutely hospitalized older adults.

Being tested
Physical Activity During and After Hospitalization
Keywords
Hospital-associated disability, Geriatric, Physical activity, Hospital mobility, Older adults
Medical subject headings
Acute Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity During and After HospitalizationOther

    Participants will receive standard care throughout hospitalization. In addition to standard care, participants will take part in a single supervised assessment of their ability and preferences for different types of physical activity. The assessment includes hallway walking (200 steps, with walking aids or assistance if needed) and resistance exercise consisting of three sets of 8-12 repetition maximum sit-to-stands. Participants will also be asked about their preference for group-based functional training and about their motivation and barriers related to physical activity.

    Physical activity will be objectively measured using SENS motion® sensor technology continuously during hospitalization and for seven consecutive days prior to the 8-week follow-up after discharge. Self-reported mobility during hospitalization will also be assessed.

    After discharge, participants' experiences, motivation, barriers, and preferences related to physical activity and rehabilitation will be explored th

Study groups in NCT07830381
Study groupRoleWhat they receive
Acutely Hospitalized Older AdultsA prospective cohort of 170 adults aged 65 years or older acutely admitted to the Department of Geriatrics or the Department of Cardiology at Copenhagen University Hospital - Hvidovre. Participants will be consecutively recruited within 48 hours of admission and followed during hospitalization and at 1, 4, and 8 weeks after discharge.
Receives: Other: Physical Activity During and After Hospitalization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital-associated disability

    Hospital-associated disability (HAD) is defined as a new decline in functional independence in at least one activity compared with the participant's pre-admission level. Functional independence is assessed using three components: six basic activities of daily living from the Katz Index (bathing, dressing, toileting, transferring, continence, and feeding); five instrumental activities of daily living inspired by the Lawton IADL Index (shopping, housekeeping, laundry, food preparation, and medication management); and four mobility-related activities (walking 400 meters without rest, climbing or descending one flight of stairs without rest, carrying 5 kg, and driving a car). Each activity is scored as unable to perform (0), able to perform with assistance (1), or able to perform independently (2). Participants with a decline in independence in at least one activity compared with their retrospectively assessed pre-admission level are classified as having HAD.

    Measured: At inclusion and 1, 4 and 8 weeks after discharge

  2. Imagined ability to perform physical activity during hospitalization

    Participants' imagined ability to perform physical activity during hospitalization will be assessed by asking whether they can imagine performing the activity daily during hospitalization. Imagined ability will be assessed for hallway walking (200 steps) and resistance exercise (three sets of 8-12 sit-to-stand repetitions) and group-based functionel training.

    Measured: At inclusion

  3. Actual ability to perform physical activity during hospitalization

    Participants' actual ability to perform physical activity during hospitalization will be assessed by asking them to perform hallway walking (200 steps) and resistance exercise (three sets of 8-12 sit-to-stand repetitions). For each activity, actual ability will be categorized as able to complete the activity as defined, 0) unable to complete the activity, 1) able to complete the activity with assistance and 2) able to complete the activity independently. Reasons for inability to complete an activity will be recorded.

    Measured: At inclusion

  4. Preferred type of physical activity during hospitalization

    Participants will be asked which type of physical activity they prefer: hallway walking, resistance training and group-based functional training. (Group-based functional training will be assessed as a preference only and will not be physically performed as part of the assessment).

    Measured: At inclusion

Secondary outcomes (5)
  1. Mean Daily steps

    Number of daily steps assessed by a SENS motion® accelerometer worn continuously from inclusion and throughout hospitalization and for seven consecutive days prior to the 8-week follow-up after discharge.

    A measurement day is considered valid if more than 20 hours of 24-hour mobility data are available. For each participant, mean daily step count is calculated across all available valid days within each measurement period.

    Measured: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up

  2. Mean daily uptime

    Daily time spent in uptime assessed by a SENS motion® accelerometer worn continuously from inclusion and throughout hospitalization and for seven consecutive days prior to the 8-week follow-up after discharge.

    A measurement day is considered valid if more than 20 hours of 24-hour mobility data are available. For each participant, mean daily step count is calculated across all available valid days within each measurement period.

    Measured: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up

  3. Mean daily walking

    Daily time spent walking assessed by a SENS motion® accelerometer worn continuously from inclusion and throughout hospitalization and for seven consecutive days prior to the 8-week follow-up after discharge.

    A measurement day is considered valid if more than 20 hours of 24-hour mobility data are available. For each participant, mean daily step count is calculated across all available valid days within each measurement period.

    Measured: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up

  4. Mean daily standing

    Daily time spent standing assessed by a SENS motion® accelerometer worn continuously from inclusion and throughout hospitalization and for seven consecutive days prior to the 8-week follow-up after discharge.

    A measurement day is considered valid if more than 20 hours of 24-hour mobility data are available. For each participant, mean daily step count is calculated across all available valid days within each measurement period.

    Measured: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up

  5. Mean daily lying/sitting

    Daily time spent sitting or lying assessed by a SENS motion® accelerometer worn continuously from inclusion and throughout hospitalization and for seven consecutive days prior to the 8-week follow-up after discharge.

    A measurement day is considered valid if more than 20 hours of 24-hour mobility data are available. For each participant, mean daily step count is calculated across all available valid days within each measurement period.

    Measured: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07830381
Sponsor's protocol ID
RESTART PhD - VEK (H-26035511)
Status last verified
Sep 2026
First submitted
9 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to Danish data protection legislation, individual participant data cannot be publicly shared. Access to pseudonymized data may be granted upon reasonable request and approval by the Danish Data Protection Agency.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Disease and Old Age, run by Hvidovre University Hospital 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lea Kromann Etzerodt, MHSc (+4538620210, lea.kromann.johansen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital-associated disability (time frame: At inclusion and 1, 4 and 8 weeks after discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Sep 2026.

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