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| ID | Type | Description | Link |
|---|---|---|---|
| 3165-00244B | Other Grant/Funding Number | Independent Research Fund Denmark |
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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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 exercise, with or without an individualized nutritional plan and intervention, can prevent this fall in functional ability during hospital stay among older patients.
Furthermore, this study seeks to investigate if it is feasible to carry out such a exercise and nutritional intervention in a hospital setting, and to obtain viewpoints regarding exercise and nutrition during hospital stay from older patients. This study aims to produce experience for at bigger randomized controlled study expected later in 2025
Introduction 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 the combined effect of exercise and optimized nutrition/hydration will be more effective compared to exercise and standard care, and additionally improve the nutritional and hydrational status and lower risk of delirium during hospital stay.
Before initiating a large scale RCT, a study examining the feasibility of the design will be performed.
The Feasibility-pilot study will include 25 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 and quality of life. The Participants will receive 2 x 30 supervised exercis and a personalized nutritional plan, including refeeding risk management. In addition, the participants will be interviewed approximately 20 minutes the day before discharge. Based on predefined progression criteria using the traffic light model and qualitative feedback from the participants obtained from interviews and a new power calculation of sample size based on representative baseline characteristics, changes to design in the following RCT will be made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and nutrition intrvention | Experimental | During hospitalization, 2x 30 minutes of supervised exercise. Furthermore during hospitalization, an inital nutrition plan by a trained dietician, based on Nutrional risk, identifying of nutrion impact symtomes, daily nutritional intake regristration and adjustments to the nutrion plan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise, supervised | Other | nital nutrition plan by a trained dietician, based on Nutritional risk, identifying of nutrion impact symtomes, daily nutritional intake regristration and adjustments to the nutrion plan |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility to enter the study | 75 % or more of screened patients eligible to enter the study, based on exclusion and inclusion criteria. | on inclusion day |
| Measure | Description | Time Frame |
|---|---|---|
| Inclusion and recruitment | 1 participant included pr weekday and more than 75% of eligible patients accept inclusion after proposal | on inclusion day |
| Adherence to protocol: Exercise team workflow |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 and nutrional intervention, As well as participants charecteristics and outcome data, in a data repository, when the data can be fully anonymized
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Data repository, URL link within the published feasibility study
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Feasibility Study
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90 % of planned exercise bouts initiated.
| From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days. |
| Adherence to protocol: Exercise outcome | 85 % of initiated exercise bouts completed with 75 % of planned exercise | From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days. |
| Adherence to protocol: Dietician workflow | 95 % or more of participants in nutrition intervention group receiving an individualized nutritional plan on inclusion day | Inclusion day |
| Adherence to protocol: Nutrition outcome | 80 % of participants with 75 % or more of planned daily caloric intake 4 days after admission | Four days after inclusion |
| Outcome data: Barthel index 100 | 90 % of included participants with data collection on planned RCT substudy 1 primary outcomes (Barthel Index 100 (0-100, 0 complete dependency in ADL function, 100 complete independence in ADL function) | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Outcome data: Secondary (Cumulated Ambulation Score) | 75 % of included participants with data collection on planned RCT secondary outcomes Cumulated Ambulation Score (assesed mobility, 0-6) | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Adverse effects | No falls or function-limiting injuries related to exercise, few minor injuries. No cases of manifest refeeding syndrome related to the nutrition intervention. | From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days. |
| Assessment duration | All assessments completed faster than 120 minutes | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Dropout | Less than 15 % dropout of included participants | From inclusion to discharge from the geriatric department, varying fror each participant, but estimated 3-14 days. |
| Outcome data: Primary, Knee extension strength | 90 % of included participants with data collection on planned RCT substudy 2 primary outcomes (Knee extension strength, maximal voluntary contraction, newton meter) | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Outcome data: Secondary (Hand grip strength ) | 75 % of included participants with data collection on planned RCT secondary outcomes: Hand grip strength, kilogram | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Outcome data: Secondary (Sit-to-stand test ) | 75 % of included participants with data collection on planned RCT secondary outcomes: Sit-to-stand test, number of repetitions in 30 seconds, continous scale | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Outcome data: Secondary (Gait speed) | 75 % of included participants with data collection on planned RCT secondary outcomes: Gait speed, velocity (meters/seconds) | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Outcome data: Secondary (Quadriceps muscle thickness) | 75 % of included participants with data collection on planned RCT secondary outcomes: Quadriceps muscle thickness, ultrasound, millimeters | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Outcome data: Secondary (muscle mass) | 75 % of included participants with data collection on planned RCT secondary outcomes: muscle mass, bioimpedance analysis, kilogram | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Outcome data: Secondary (appetite) | 75 % of included participants with data collection on planned RCT secondary outcomes: appetite, simplified nutritional appettite questionaire. | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| Outcome data: Secondary (quality of life) | 75 % of included participants with data collection on planned RCT secondary outcomes: quality of life, EuroQol- 5D-5 levels questionaire | At inclusion and again at discharge from the geriatric department, varying for each participant, but estimated 3-14 days after inclusion. |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic 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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