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

Sponsor
Odense University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05798169
Collaborator
University of Copenhagen (Other), Nottingham University Hospitals NHS Trust (Other)
274
1
2
16.9
16.3

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
274 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults
Actual Study Start Date :
Jan 5, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Group of participants receiving resistance training during hospitalisation

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

Sham Comparator: Control Group

Group of participants receiving sham training during hospitalisation

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline B-mode ultrasonography [Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week).]

    Muscle architecture of the m Vastus Lateralis assessed with B-mode ultrasonography.

  2. Change from baseline 4 meter Gait Speed Test [Baseline (Day of hospitalisation) to day of discharge from hospital (an average of a week).]

    Physical performance evaluated by the 4m Gait Speed test

  3. Change from baseline B-mode ultrasonography [Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up]

    Muscle architecture of the muscle vastus lateralis assessed with B-mode ultrasonography.

  4. Change from baseline 4 meter Gait Speed Test [Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up]

    Physical performance evaluated by the 4m Gait Speed test

Secondary Outcome Measures

  1. Change from baseline 30s Chair Stand test [Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)]

    Maximal muscle strength of the lower extremities evaluated by the 30s Chair Stand Test or the m30s Chair Stand Test (Modified).

  2. Change from baseline Barthel-Index 100 (Shahs version) [Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)]

    Functional level evaluated by The Barthel-Index 100 (Shahs version)

  3. Change from baseline Bioimpedance [Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)]

    Muscle quantity (kg) on wholebody level evaluated by Bioimpedance

  4. Length of hospital stay [Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)]

    Number of days hospitalised

  5. Mortality [Baseline (day of hospitalization) to 3-months follow-up]

    Administrative registers will be used to assess mortality

  6. Unplanned hospitalisation [Day of discharge from hospital to 3-months follow-up]

    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.

  7. Individual level of physiotherapy [Baseline (day of hospitalisation) to 3-months follow-up]

    Adminstrative registers and municipalities health records will be used to assess the individual level of physiotherapy (minutes of consultation) in the period of inclusion.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Geriatric Deparment OUH Svendborg Hospital Svendborg FYN Denmark 5700

Sponsors and Collaborators

  • Odense University Hospital
  • University of Copenhagen
  • Nottingham University Hospitals NHS Trust

Investigators

  • Study Director: Kristian B Buhl, MD, Department of Geriatric, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lisbeth Rosenbek Minet, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT05798169
Other Study ID Numbers:
  • ARTMAP
First Posted:
Apr 4, 2023
Last Update Posted:
Apr 4, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2023