Bispebjerg Hospital
Copenhagen, Capital Region, 2400, Denmark
Location contact
Charlotte Suetta, Professor
CONTACT
Kristian Lolck, MD ph.d. student
SUB_INVESTIGATOR
Kristian V Lolck, MD, ph.d. student
CONTACT
NCT Number: NCT07373587
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
Copenhagen, Capital Region, 2400, Denmark
Charlotte Suetta, Professor
CONTACT
Kristian Lolck, MD ph.d. student
SUB_INVESTIGATOR
Kristian V Lolck, MD, ph.d. student
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Training, Physiotheraphy
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
describes the level of independence in activities of daily living, score of 0 equals total dependence and a score of 100 equals total independence
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge
Cumulated Ambulation Score (assesed mobility, 0 (lowest)-6(highest))
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
(Knee extension strength, maximal voluntary contraction, newton meter)
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Hand grip strength, kilogram
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Sit-to-stand test, number of repetitions in 30 seconds, continous scale
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Gait speed, velocity (meters/seconds)
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
Quadriceps muscle thickness, ultrasound, millimeters
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
muscle mass, bioimpedance analysis, kilogram
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
appetite, simplified nutritional appettite questionaire. Scale, 4-20, lower values indicates higher risk of insufficient nutritional intake
Time frame: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
quality of life, EuroQol- 5Dimensions-5 levels, questionaire, scale from 1-5 i each of five dimensions, higher scores indicates lower quality of life
Time frame: From inclusion to 30 days after discharge from hospital
Participants readmitted to the hospital within 30 days of discharge, categorical yes or no
Time frame: From inclusion to 1 year after discharge from hospital
Participant diseased at 30 days, 90 days or 1 year after discharge from hospital, categorical, yes/no
Time frame: Retrospectively 14 days berfore inclusion to 3 months after discharge from hospital
Need for municipal care services, number of weekly visits, minutes of care service
Time frame: From inclusion to discharge from hospital (aproximately 5 days after inclusion)
Discharged to own home, temporary rehabillitation or permanent care facility, categorical, yes or no
Time frame: From inclusion to discharge from hospital (aproximately 5 days after inclusion)
Steps taken and time upright, accelerometer
Contact information is provided by the study sponsor or research team.
Charlotte Suetta, professor
CONTACT
Kristian V Lolck, MD, Ph.d. student
CONTACT
Bispebjerg Hospital
Other
Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Randomized Controlled Trial
Acronym: PrevHAD RCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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