AgingNCT04019132
Power During Functional Tasks in Older Adults
An observational study of Aging, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Muscle function test
- How many people
- 284 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jan 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy young to older adults
Who may be able to join
- Age >20
Who cannot join
- Unstable cardiovascular diseases
- Fever or acute infection
- Cognitive or physical malfunctioning that hinders the understanding or performance of tests and/or instructions
Trial locations and contacts
1 site in 1 country.
Belgium1 site
KU Leuven - Department of Movement Sciences
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Power During Functional Tasks in Older Adults: Reliability, Reference Values and Relationship With Other Outcome Measurements Related to Sarcopenia
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.
Read the detailed 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.
- Conditions
- Aging
- Being tested
- Muscle function test
- Keywords
- Muscle Power, Functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle function testDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Older adults | Older adults aged >65 years Receives: Diagnostic Test: Muscle function test | |
| Young group | Younger adults between the age of 20 and 40 years Receives: Diagnostic Test: Muscle function test | |
| Middle-aged group 1 | Adults between the age of 40 and 55 years Receives: Diagnostic Test: Muscle function test | |
| Middle-aged group 2 | Adults between the age of 55 and 65 years Receives: Diagnostic Test: Muscle function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
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
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
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
Measured: 1 test moment of approximately 30 minutes, planned between September 2019 and July 2020
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.
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Handgrip strength
Handgrip strength (kg) evaluated with a Jamar dynamometer
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Jumping height
Jumping height (in cm) measured during a standardized jump test
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Physical activity
Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry
Measured: 1 week
Number of steps/stairs a day
Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry
Measured: 1 week
Secondary outcomes (7)
Number of repetitions during a 30s sit-to-stand test
Number of complete sit-to-stand transitions in 30 sec.
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
6min walk distance
The walk distance (in m) covered in 6 min.
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Balance
Number of seconds a participant can hold a tandem stand, a semi-tandem stand or with the feet together
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Maximal gait speed
The average speed to walk 3m as fast as possible (in m/s)
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Usual gait speed
The average speed to walk 4m at a usual pace (in m/s)
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Maximal isometric strength
Maximal strength (Nm) is measured by means of unilateral isometric knee-extensor tests on a Biodex Dynamometer
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Maximal isokinetic strength
Maximal strength (Nm) is measured by means of unilateral isokinetic knee-extensor tests on a Biodex Dynamometer
Measured: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start20 Jan 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019132
- Sponsor's protocol ID
- S62540
- Status last verified
- May 2022
- First submitted
- 2 Jul 2019
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power During Functional Tasks in Older Adults: Reliability, Reference Values and Relationship With Other Outcome Measurements Related to Sarcopenia
- ClinicalTrials.gov ID
- NCT04019132
- Acronym / sponsor ID
- S62540
- Conditions
- Aging
- Keywords
- Muscle Power, Functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Older adults | – | Diagnostic Test: Muscle function testOlder adults aged >65 years |
| Young group | – | Diagnostic Test: Muscle function testYounger adults between the age of 20 and 40 years |
| Middle-aged group 1 | – | Diagnostic Test: Muscle function testAdults between the age of 40 and 55 years |
| Middle-aged group 2 | – | Diagnostic Test: Muscle function testAdults between the age of 55 and 65 years |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy young to older adults
Key inclusion criteria (1 listed)
- Age >20
Key exclusion criteria (3 listed)
- Unstable cardiovascular diseases
- Fever or acute infection
- Cognitive or physical malfunctioning that hinders the understanding or performance of tests and/or instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle function testBody 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) | Diagnostic test | Middle-aged group 1, Middle-aged group 2, Older adults, Young group |
Primary outcome
Lower limb muscle power during a stair climb test
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
The power (watt) needed to perform stair climbing is calculated using a 3D accelerometer (DynaPort MoveTest, McRoberts), worn at the back of the participant
Lower limb muscle power during a sit-to-stand test
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
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
Reliability of power measurements measured with a 3D accelerometer
Time frame: 1 test moment of approximately 30 minutes, planned between September 2019 and July 2020
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
Rate of power (force-velocity) development
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
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.
Handgrip strength
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Handgrip strength (kg) evaluated with a Jamar dynamometer
Jumping height
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Jumping height (in cm) measured during a standardized jump test
Physical activity
Time frame: 1 week
Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry
Number of steps/stairs a day
Time frame: 1 week
Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry
7 secondary outcomes
Number of repetitions during a 30s sit-to-stand test
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
6min walk distance
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Balance
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Maximal gait speed
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Usual gait speed
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Maximal isometric strength
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Maximal isokinetic strength
Time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb muscle power during a stair climb test (time frame: 1 test moment of approximately 1 hour, planned between September 2019 and July 2020). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.