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| ID | Type | Description | Link |
|---|---|---|---|
| 3165-00244B | Other Grant/Funding Number | Independent Research Fund Denmark |
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Aproximately a third of persons older than 70 years lose physical function and ability to take care of themselves during a stay at a hospital. This is associated to an increased risk of readmission and mortality. Earlier research has shown that insufficient nutrition and physical activity during hospital stay, leading to a loss in muscle mass and strength, plays an important role in this fall in functionality. This study aims to examine if a structured and supervised resistance and mobility exercise intervention, can prevent this fall in functional ability during hospital stay among older patients. The Impact of nutritional status will be investigated by registrering caloric, protein and hydtrational intake during the study period.
Older persons are highly susceptible to hospital associated disability (HAD), defined by a loss of physical function during hospitalization, leading to increased dependency, morbidity, and mortality. Key factors in developing HAD are physical inactivity, malnutrition and dehydration, leading to a decline in muscle mass and muscle strength. Therefore, there is a need to develop effective nutritional and exercise interventions for older patients, during hospitalization. Hypothesis: This study expects that a mobility-graded individualized exercise intervention will effectively prevent a decline in activities of daily living (ADL) function, mobility level, physical function, muscle and strength, and reduce the length of stay, risk of re-admission and mortality among older patients during hospital stay. The investigators furthermore hypothesize that sufficcient nutrition and hydration will improve the impact of the exercise intervention. The study is designed as a randomized controlled trial, and will include 360 participants, men and women, ≥ 65 years old from the geriatric care unit of Bispebjerg Hospital, Denmark. After inclusion, participants will have estimated nutritional status, frailty and mobility, muscle mass and strength, physical function, ADL function, cognitive function and quality of life. Futhermore, blood samples for analysis of anabolic and inflammatory biomarkers as well as microbiome samples will be taken at baseline testing. After baseline testing, the participants will be divided randomely 1:1 into a control group and an intervention group. All participants will have nutritional and hydrational intake registered and wear accelerometers during the study period. The participants in the intervention group will receive 2 x 30 minutes supervised exercise (resistance and mobility) every day during the stury period. At discharge or transfer from the geriatric care unit, participants will be tested for mobility, muscle mass and strength, physical function, ADL function, cognitive function and quality of life. 1 Month after discharge from hospital, the participants will recieve af telefon interview, reporting on ADL-function, mobility, quality of life and nutritional status. Participants succesfully reached by telephone interview, will be asked further permission for a homevisit, where muscle strength and mass, physical function, mobility, cognitive function and ADL function will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group will recieve usual care at the geriatric care unit, with mobility exercise performed based on individual preferences and ability, performed by regular care personelle and regular physiotherapy staff. | |
| Exercise intervention | Experimental | The exercise intervention group will recieve two times 30 minutes of supervised exercise (mobility and resistance exercise) every day during their stay at the geriatrich care unit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | The participants in the intervention group will recieve supervised exercise two times 30 minutes each day during hospitalization. The first exercise pass consists of resistance exercise, and can be performed supine in bed, sitting on the edge of the bed, and in a close-by exercise area, based on participants mobility level. The second exercise pass consists of mobility exercise, aiming to transfer the participant from supine in the bed to sitting position, transfer to chair, walking with or without walking aids or walking on stairs. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in activities of daily living (ADL) function, by Barthel index-100 | describes the level of independence in activities of daily living, score of 0 equals total dependence and a score of 100 equals total independence | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mobility by Cumulated Ambulation Score | Cumulated Ambulation Score (assesed mobility, 0 (lowest)-6(highest)) | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge |
| Changes in Knee extension strength, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristian V Lolck, MD, Ph.d. student | Contact | +4560612914 | kristian.kaltoft.lolck@regionh.dk | |
| Charlotte Suetta, professor | Contact | charlotte.suetta@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Charlotte Suetta, Professor | Geriatric research unit, Bispebjerg hospital, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | Capital Region | 2400 | Denmark |
We will share the protocol for the exercise intervention, as well as participants charecteristics and outcome data, in a data repository, when the data can be fully anonymized
When the main study is published, estimated 1. march 2028, with no end date
Data repository, URL link within the published study
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Outcomes at discharge will be measured by a different investigator than at baseline, to mask the baseline measures.
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(Knee extension strength, maximal voluntary contraction, newton meter) |
| From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Changes in Hand Grip Strength | Hand grip strength, kilogram | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Changes in Sit-to-stand performance | Sit-to-stand test, number of repetitions in 30 seconds, continous scale | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Changes in Gait speed | Gait speed, velocity (meters/seconds) | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Changes in Quadriceps muscle thickness | Quadriceps muscle thickness, ultrasound, millimeters | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Changes in muscle mass | muscle mass, bioimpedance analysis, kilogram | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Changes in appetite | appetite, simplified nutritional appettite questionaire. Scale, 4-20, lower values indicates higher risk of insufficient nutritional intake | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Changes in quality of life | quality of life, EuroQol- 5Dimensions-5 levels, questionaire, scale from 1-5 i each of five dimensions, higher scores indicates lower quality of life | From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge. |
| Readmission 30 days from discharge | Participants readmitted to the hospital within 30 days of discharge, categorical yes or no | From inclusion to 30 days after discharge from hospital |
| Mortality 30 days, 90 days and 1 year after discharge | Participant diseased at 30 days, 90 days or 1 year after discharge from hospital, categorical, yes/no | From inclusion to 1 year after discharge from hospital |
| Changes in municipal care needs at discharge, 1 month and 3 months after discharge | Need for municipal care services, number of weekly visits, minutes of care service | Retrospectively 14 days berfore inclusion to 3 months after discharge from hospital |
| Discharge destination | Discharged to own home, temporary rehabillitation or permanent care facility, categorical, yes or no | From inclusion to discharge from hospital (aproximately 5 days after inclusion) |
| Physical activity during hospitalization | Steps taken and time upright, accelerometer | From inclusion to discharge from hospital (aproximately 5 days after inclusion) |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |