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

Primary Purpose

Sarcopenia, Functional Decline, Muscle Architecture

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Geriatric Deparment OUH Svendborg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Group of participants receiving resistance training during hospitalisation

Group of participants receiving sham training during hospitalisation

Outcomes

Primary Outcome Measures

Change from baseline B-mode ultrasonography
Muscle architecture of the m Vastus Lateralis assessed with B-mode ultrasonography.
Change from baseline 4 meter Gait Speed Test
Physical performance evaluated by the 4m Gait Speed test
Change from baseline B-mode ultrasonography
Muscle architecture of the muscle vastus lateralis assessed with B-mode ultrasonography.
Change from baseline 4 meter Gait Speed Test
Physical performance evaluated by the 4m Gait Speed test

Secondary Outcome Measures

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).
Change from baseline Barthel-Index 100 (Shahs version)
Functional level evaluated by The Barthel-Index 100 (Shahs version)
Change from baseline Bioimpedance
Muscle quantity (kg) on wholebody level evaluated by Bioimpedance
Length of hospital stay
Number of days hospitalised
Mortality
Administrative registers will be used to assess mortality
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.
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.

Full Information

First Posted
November 7, 2022
Last Updated
March 22, 2023
Sponsor
Odense University Hospital
Collaborators
University of Copenhagen, Nottingham University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05798169
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Copenhagen, Nottingham University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Functional Decline, Muscle Architecture, Gait Speed, Ultrasound, Physical Performance, Resistance Training, Hospitalisation, Acutely Ill, Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Group of participants receiving resistance training during hospitalisation
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Group of participants receiving sham training during hospitalisation
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
Moderate resistance training by a innovative training robot 2 times a day during hospitalisation
Primary Outcome Measure Information:
Title
Change from baseline B-mode ultrasonography
Description
Muscle architecture of the m Vastus Lateralis assessed with B-mode ultrasonography.
Time Frame
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week).
Title
Change from baseline 4 meter Gait Speed Test
Description
Physical performance evaluated by the 4m Gait Speed test
Time Frame
Baseline (Day of hospitalisation) to day of discharge from hospital (an average of a week).
Title
Change from baseline B-mode ultrasonography
Description
Muscle architecture of the muscle vastus lateralis assessed with B-mode ultrasonography.
Time Frame
Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up
Title
Change from baseline 4 meter Gait Speed Test
Description
Physical performance evaluated by the 4m Gait Speed test
Time Frame
Change from baseline (day of hospitalisation) to 1-month follow-up and 3-months follow-up
Secondary Outcome Measure Information:
Title
Change from baseline 30s Chair Stand test
Description
Maximal muscle strength of the lower extremities evaluated by the 30s Chair Stand Test or the m30s Chair Stand Test (Modified).
Time Frame
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Title
Change from baseline Barthel-Index 100 (Shahs version)
Description
Functional level evaluated by The Barthel-Index 100 (Shahs version)
Time Frame
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Title
Change from baseline Bioimpedance
Description
Muscle quantity (kg) on wholebody level evaluated by Bioimpedance
Time Frame
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Title
Length of hospital stay
Description
Number of days hospitalised
Time Frame
Baseline (day of hospitalisation) to day of discharge from hospital (an average of a week)
Title
Mortality
Description
Administrative registers will be used to assess mortality
Time Frame
Baseline (day of hospitalization) to 3-months follow-up
Title
Unplanned hospitalisation
Description
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.
Time Frame
Day of discharge from hospital to 3-months follow-up
Title
Individual level of physiotherapy
Description
Adminstrative registers and municipalities health records will be used to assess the individual level of physiotherapy (minutes of consultation) in the period of inclusion.
Time Frame
Baseline (day of hospitalisation) to 3-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeppe G Phillip, MSc
Phone
+4521810993
Email
jeppe.grabov.phillip@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lisbeth R Minet, Professor
Phone
+4525782465
Email
lisbeth.minet@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian B Buhl, MD
Organizational Affiliation
Department of Geriatric, Odense University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Geriatric Deparment OUH Svendborg Hospital
City
Svendborg
State/Province
FYN
ZIP/Postal Code
5700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeppe G Phillip
Phone
+4521810993
Email
jeppe.grabov.phillip@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan

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

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