Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults

Sarcopenia Clinical Trial

Official title:

Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798169
• Other study ID #: ARTMAP
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Odense University Hospital
• Contact: Jeppe G Phillip, MSc
• Phone: +4521810993
• Email: jeppe.grabov.phillip[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acutely Ill
• Functional Decline
• Hospitalisation
• Muscle Architecture
• Older Adults
• Physical Performance
• Resistance Training
• Sarcopenia
• Ultrasound

Intervention

Other:
• Resistance training
Moderate resistance training by a innovative training robot 2 times a day during hospitalisation

Locations

Country	Name	City	State
Denmark	Geriatric Deparment OUH Svendborg Hospital	Svendborg	FYN

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Nottingham University Hospitals NHS Trust, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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