Clinical trial NCT05798169: Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults
Official title: Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Functional Decline
Muscle Architecture
Gait Speed
Ultrasound
Physical Performance
Resistance Training
Hospitalisation
Acutely Ill
Older Adults
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Nottingham University Hospitals NHS Trust
First posted: 2023-04-04
Enrollment: 274
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcopenia characterised by loss of muscle mass, muscle strength and physical performance burdens many older adults since the condition is related to functional decline. Periods of inactivity such as during hospitalisation leads to further functional decline. It has been reported that the loss of muscle mass associated with sarcopenia not only entails a decrease in muscle mass but also changes in muscle architecture. Knowledge on changes in muscle architecture is essential since it is one of the most important determinants on muscle strength and thus physical performance. The main objective of this study is to investigate changes in muscle architecture and physical performance during acute hospitalisation and after discharge in older adults and subsequently the effectiveness of resistance training of the lower limb during acute hospitalisation. If successful, our study could have a great impact on the individual, as well as societal level, due to a better understanding of the factors related to sarcopenia and the prevention of functional decline as a result of hospitalisation.


Eligibility criteria: Inclusion Criteria:

* ≥65 years of age
* Able to ambulate before hospitalization (with/without assistance)
* Able to communicate with the research team
* Expected length of stay ≥2 days
* Residing on Funen

Exclusion Criteria:

* Able to ambulate without assistance during current hospitalization
* Known severe dementia
* Positive Confusion and Assessment Method score
* Patients who have received less than 3 resistance training sessions at discharge
* Terminal illness
* Recent major surgery or lower extremity bone fracture in the last 3 months
* Conditions contradicting use of ROBERT(unstable vertebral-, pelvic, or lower extremity fractures
* high intracranial pressure
* pressure ulcers or risk of developing pressure ulcers due to fragile skin
* patients with medical instability)
* Metastases at femur hip
* Deemed not suitable for resistance training sessions with the robot by the healthcare professional.

Primary outcomes:
measure: Change from baseline B-mode ultrasonography
timeFrame: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week).
measure: Change from baseline 4 meter Gait Speed Test
timeFrame: Baseline (Day of hospitalisation) to day of discharge from hospital (an average of a week).
measure: Change from baseline B-mode ultrasonography
timeFrame: Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up
measure: Change from baseline 4 meter Gait Speed Test
timeFrame: Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up
Secondary outcomes:
measure: Change from baseline 30s Chair Stand test
timeFrame: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
measure: Change from baseline Barthel-Index 100 (Shahs version)
timeFrame: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
measure: Change from baseline Bioimpedance
timeFrame: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
measure: Length of hospital stay
timeFrame: Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
measure: Mortality
timeFrame: Baseline (day of hospitalization) to 3-months follow-up
measure: Unplanned hospitalisation
timeFrame: Day of discharge from hospital to 3-months follow-up
measure: Individual level of physiotherapy
timeFrame: Baseline (day of hospitalisation) to 3-months follow-up
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Geriatric Deparment OUH Svendborg Hospital
state: FYN
Study officials:
affiliation: Department of Geriatric, Odense University Hospital
name: Kristian B Buhl, MD
role: STUDY_DIRECTOR
References: