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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04019132
Other study ID # S62540
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2020
Est. completion date March 1, 2022

Study information

Verified date May 2022
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary aim of this study is to optimize the methodology to measure lower limb power in older adults, so that clinicians are able to detect functional problems in this population earlier.


Description:

Aging is associated with slower movement patterns, a higher fall risk and a restriction in functionality. This will lead to an increase in the number of dependent elderly and a high socio-economic burden. From the age of 40, a systematic loss of muscle mass and muscle force, also known as sarcopenia, will occur. In addition, performing daily tasks requires the production of muscle force at a certain speed. The product of force and speed, power, decreases even earlier and faster than muscle force. This power is typically measured with specialized equipment, which limits the large-scale applicability. With the help of accelerometry there is the possibility to measure power during more functional tasks and movements, which benefits the applicability, but the reliability, reference values and link with other outcome measurements related to sarcopenia has to be investigated.


Recruitment information / eligibility

Status Completed
Enrollment 284
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Age >20 Exclusion Criteria: - Unstable cardiovascular diseases - Fever or acute infection - Cognitive or physical malfunctioning that hinders the understanding or performance of tests and/or instructions

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Muscle function test
Body measurements, power and strength tests of the knee extensor muscle, handgrip strength, functional capacity tests, objective measurement of physical activity (subgroup of older adults, n=50)

Locations

Country Name City State
Belgium KU Leuven - Department of Movement Sciences Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lower limb muscle power during a stair climb test The power (watt) needed to perform stair climbing is calculated using a 3D accelerometer (DynaPort MoveTest, McRoberts), worn at the back of the participant 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Primary Lower limb muscle power during a sit-to-stand test The power (watt) needed to perform 5 sit-to-stand transitions and a 30 sec. sit-to-stand test is calculated using a 3D accelerometer (DynaPort MoveTest, McRoberts), worn at the back of the participant 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Primary Reliability of power measurements measured with a 3D accelerometer Reliability of power measurements (watt) measured with a 3D accelerometer (DynaPort MoveTest, McRoberts) worn during functional activities (stair climbing, sit-to-stand test) three times within a period of 2 weeks 1 test moment of approximately 30 minutes, planned between September 2019 and July 2020
Primary Rate of power (force-velocity) development Participants perform a test protocol on a Biodex Dynamometer. The rate of power development (watt/s) is defined as the linear slope of the power-time curve and is measured from the onset of movement till peak power. 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Primary Handgrip strength Handgrip strength (kg) evaluated with a Jamar dynamometer 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Primary Jumping height Jumping height (in cm) measured during a standardized jump test 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Primary Physical activity Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry 1 week
Primary Number of steps/stairs a day Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry 1 week
Secondary Number of repetitions during a 30s sit-to-stand test Number of complete sit-to-stand transitions in 30 sec. 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Secondary 6min walk distance The walk distance (in m) covered in 6 min. 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Secondary Balance Number of seconds a participant can hold a tandem stand, a semi-tandem stand or with the feet together 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Secondary Maximal gait speed The average speed to walk 3m as fast as possible (in m/s) 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Secondary Usual gait speed The average speed to walk 4m at a usual pace (in m/s) 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Secondary Maximal isometric strength Maximal strength (Nm) is measured by means of unilateral isometric knee-extensor tests on a Biodex Dynamometer 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Secondary Maximal isokinetic strength Maximal strength (Nm) is measured by means of unilateral isokinetic knee-extensor tests on a Biodex Dynamometer 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
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