- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07830381
Physical Activity During Hospitalization and Hospital-Associated Disability
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.
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Lea Kromann Etzerodt, MHSc
- Telefonní číslo: +4538620210
- E-mail: lea.kromann.johansen.01@regionh.dk
Studijní záloha kontaktů
- Jméno: Mette Merete Pedersen, PhD
- Telefonní číslo: +4538623350
- E-mail: mette.merete.pedersen@regionh.dk
Studijní místa
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Hvidovre, Dánsko
- Copenhagen University Hospital, Hvidovre
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Kontakt:
- Lea Kromann Etzerodt, MHSc
- Telefonní číslo: +4538620210
- E-mail: lea.kromann.johansen.01@regionh.dk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Older adults (65 years or older) acutely admitted to the Department of Geriatrics or the Department of Cardiology at Copenhagen University Hospital, Hvidovre.
Popis
Inclusion Criteria:
- Aged 65 years or older
- Acutely admitted to the Department of Geriatrics or the Department of Cardiology
Exclusion Criteria:
- In isolation
- Delirium
- Unable to provide informed consent
- Unable to speak and understand Danish
- Unable to take one step
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Acutely Hospitalized Older Adults
A 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. |
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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Hospital-associated disability
Časové okno: At inclusion and 1, 4 and 8 weeks after discharge
|
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. |
At inclusion and 1, 4 and 8 weeks after discharge
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Imagined ability to perform physical activity during hospitalization
Časové okno: At inclusion
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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. |
At inclusion
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Actual ability to perform physical activity during hospitalization
Časové okno: At inclusion
|
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. |
At inclusion
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Preferred type of physical activity during hospitalization
Časové okno: At inclusion
|
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). |
At inclusion
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean Daily steps
Časové okno: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
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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. |
From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
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Mean daily uptime
Časové okno: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
|
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. |
From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
|
|
Mean daily walking
Časové okno: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
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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. |
From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
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Mean daily standing
Časové okno: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
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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. |
From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
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Mean daily lying/sitting
Časové okno: From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
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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. |
From inclusion through hospital discharge, an average of 5 days; and 7 consecutive days before the 8-week follow-up
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Self-reported mobility
Časové okno: Days 2, 4 and 6 after inclusion during hospitalization
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Self-reported mobility by the Acute Care Mobility Assessment. A score of 0-12 can be obtained, with 0 reflecting poor mobility and 12 reflecting a high level of mobility. |
Days 2, 4 and 6 after inclusion during hospitalization
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Life space mobility
Časové okno: At inclusion and 4 and 8 weeks post discharge
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By the Life Space Assessment-DK, which measure mobility and level of dependence in mobility. A score of 0-120 can be obtained, with 0 reflecting poor mobility and 120 reflecting high mobility |
At inclusion and 4 and 8 weeks post discharge
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Self-reported pre-admission (2 weeks prior to admission) and post discharge mobility
Časové okno: At inclusion and 1, 4 and 8 weeks post discharge
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By the New Mobility Score, which assesses the ability to walk indoors and outdoors and the ability to go shopping. A score from 0-9 can be obtained, with 0 reflecting low mobility and 9 reflecting high mobility. |
At inclusion and 1, 4 and 8 weeks post discharge
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Frailty pre-admission (2 weeks prior to admission)
Časové okno: At inclusion
|
By the Clinical Frailty Scale, which is a clinical evaluation of the degree of frailty of a person. It is scored by health care professionals on a scale from 1 (very fit) to 9 (terminally ill) |
At inclusion
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Cognitive status
Časové okno: At inclusion
|
By the Orientation Memory Concentration Test, which is a screening of cognitive function. A score from 0 to 28 obtained, with lower scores reflecting poorer cognition (0-7: highly impaired; 8-17 points: moderately impaired; 18-24 points: mildly impaired; 25-28 points: no or insignificant impairment). |
At inclusion
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Basic mobility
Časové okno: At inclusion, day 2, 4 and 6 after inclusion during hospitalization and 8 weeks post discharge
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By the Cummulated Ambulation Score, which assessed the ability of a person to get in and out of bed, sit to stand from a chair and walk. It is scored from 0 to 6 with 0 reflecting inability to perform the 3 activities and a score of 6 reflecting independence in the three activities. |
At inclusion, day 2, 4 and 6 after inclusion during hospitalization and 8 weeks post discharge
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Gait speed
Časové okno: At inclusion and 8 weeks post discharge
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By the 4-meter gait speed test. It assesses the patient's current gait speed on a 4-meter course. The test is scored in m/s. |
At inclusion and 8 weeks post discharge
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Readmission
Časové okno: 6 month post discharge
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Number of readmissions within 6 months post discharge |
6 month post discharge
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Handgrip strength
Časové okno: At inclusion and 8 weeks post discharge
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Handgrip strength of the dominant hand assessed using a handheld dynamometer. Three attempts are performed, and the highest measured value is used for analysis. |
At inclusion and 8 weeks post discharge
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Lower-extemity muscle strenght
Časové okno: At inclusion and 8 weeks post discharge
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Assessed by Sit-to-stand test, as the number of times the participant can rise from and sit down on a chair during 30 seconds. |
At inclusion and 8 weeks post discharge
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Concern about falling
Časové okno: At inclusion and 1, 4 and 8 weeks post discharge
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Concern about falling during activities of daily living assessed by the 7-item Short Falls Efficacy Scale (Short FES-I). Each item is scored from 1 to 4, giving a total score from 7 to 28, with higher scores indicating greater concern about falling. |
At inclusion and 1, 4 and 8 weeks post discharge
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Lea Kromann Etzerodt, MHSc, Department of Clinical Research, Copenhagen University Hospital Hvidovre
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
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