Sarcopenia Clinical Trial
Official title:
Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults
NCT number | NCT05798169 |
Other study ID # | ARTMAP |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 5, 2023 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 274 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Geriatric Deparment OUH Svendborg Hospital | Svendborg | FYN |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Nottingham University Hospitals NHS Trust, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline B-mode ultrasonography | Muscle architecture of the m Vastus Lateralis assessed with B-mode ultrasonography. | Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week). | |
Primary | Change from baseline 4 meter Gait Speed Test | Physical performance evaluated by the 4m Gait Speed test | Baseline (Day of hospitalisation) to day of discharge from hospital (an average of a week). | |
Primary | Change from baseline B-mode ultrasonography | Muscle architecture of the muscle vastus lateralis assessed with B-mode ultrasonography. | Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up | |
Primary | Change from baseline 4 meter Gait Speed Test | Physical performance evaluated by the 4m Gait Speed test | Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up | |
Secondary | Change from baseline 30s Chair Stand test | Maximal muscle strength of the lower extremities evaluated by the 30s Chair Stand Test or the m30s Chair Stand Test (Modified). | Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week) | |
Secondary | Change from baseline Barthel-Index 100 (Shahs version) | Functional level evaluated by The Barthel-Index 100 (Shahs version) | Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week) | |
Secondary | Change from baseline Bioimpedance | Muscle quantity (kg) on wholebody level evaluated by Bioimpedance | Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week) | |
Secondary | Length of hospital stay | Number of days hospitalised | Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week) | |
Secondary | Mortality | Administrative registers will be used to assess mortality | Baseline (day of hospitalization) to 3-months follow-up | |
Secondary | Unplanned hospitalisation | Patients will be followed through a review of medical records for any unplanned Adminstrative registers will be used to assess any unplanned hospitalisation during the period of inclusion. | Day of discharge from hospital to 3-months follow-up | |
Secondary | Individual level of physiotherapy | Adminstrative registers and municipalities health records will be used to assess the individual level of physiotherapy (minutes of consultation) in the period of inclusion. | Baseline (day of hospitalisation) to 3-months follow-up |
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