Osteo Arthritis KneeNCT03680807
Power Production in Older Adults With Knee Osteoarthritis
An observational study of Osteo Arthritis Knee, run by KU Leuven at 1 site in Belgium.
Trial summary
Knee osteoarthritis is an important cause of functional disabilities at old age. Previous research has demonstrated that individuals with knee osteoarthritis have reduced knee-extensor strength in comparison to healthy individuals. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Muscle function test
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to 20 Dec 2018
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults between 50 and 80 years with or without knee osteoarthritis. Subjects are sedentary or recreationally active.
Who may be able to join
- Group with knee osteoarthritis:
- Diagnosed with knee osteoarthritis based on RX.
Who cannot join
- Healthy group:
- Systematic engagement in (resistance) exercise in the 12-months prior to participation
- Cardiovascular disease
- Neurological disorders
- Cognitive malfunctioning
- Severe knee or hip problems
Show all 12Show fewer
- Group with knee osteoarthritis:
- Systematic engagement in (resistance) exercise in the 12-months prior to participation
- Cardiovascular disease
- Neurological disorders
- Cognitive malfunctioning
- Severe hip problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Power Production in Older Adults With Knee Osteoarthritis Compared to Healthy Counterparts
Knee osteoarthritis is an important cause of functional disabilities at old age. Previous research has demonstrated that individuals with knee osteoarthritis have reduced knee-extensor strength in comparison to healthy individuals. However, rapid power production declines more than strength as a consequence of ageing and is more predictive of functional capacity. However, limited research has investigated whether individuals with knee osteoarthritis have reduced ability to develop strength and power rapidly on top of reduced maximal strength capacities, which is the primary aim of the current study.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Muscle function test
- Keywords
- Knee osteoarthritis, power production, functional capacity
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle function testDiagnostic test
Power and strength tests of the knee-extensor muscles, handgrip strength, functional capacity tests
| Study group | Role | What they receive |
|---|---|---|
| Older adults with knee osteoarthritis (>50 years) | Not described Receives: Diagnostic Test: Muscle function test | |
| Healthy older adults (> 50 years) | Not described Receives: Diagnostic Test: Muscle function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of power development
Subjects perform a test protocol on a Biodex dynamometer, consisting of isotonic contractions of the leg-extensor muscles. Subjects are instructed to kick as fast as possible against different (relative) loads. 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: up to 3 months
Secondary outcomes (7)
Maximal isometric strength
Maximal strength (Nm) is measured by means of unilateral isometric knee-extensor tests on a Biodex dynamometer.
Measured: up to 3 months
Maximal isokinetic strength
Maximal strength (Nm) is measured by means of unilateral isokinetic knee-extensor tests on a Biodex dynamometer.
Measured: up to 3 months
Stair Climbing performance
Stair ascent duration (in s), the time needed to ascent a flight of stairs.
Measured: up to 3 months
Gait speed
The average speed to walk 10m as fast as possible (in m/s).
Measured: up to 3 months
5 repetition sit-to-stand test
The time needed to perform 5 sit-to-stand transitions (in s).
Measured: up to 3 months
Timed-up-and-go
The time needed to stand up from a chair, walk 3m, turn, walk back and sit down.
Measured: up to 3 months
Handgrip strength
Handgrip strength (kg) evaluated with Jamar dynamometer.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Sep 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelien Van Roie, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680807
- Sponsor's protocol ID
- S60595
- Status last verified
- Feb 2019
- First submitted
- 18 Sep 2018
- Last updated
- 8 Feb 2019
- 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 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Production in Older Adults With Knee Osteoarthritis Compared to Healthy Counterparts
- ClinicalTrials.gov ID
- NCT03680807
- Acronym / sponsor ID
- S60595
- Conditions
- Osteo Arthritis Knee
- Keywords
- Knee osteoarthritis, power production, functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 21 Sep 2018 (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.
Knee osteoarthritis is an important cause of functional disabilities at old age. Previous research has demonstrated that individuals with knee osteoarthritis have reduced knee-extensor strength in comparison to healthy individuals. However, rapid power production declines more than strength as a consequence of ageing and is more predictive of functional capacity. However, limited research has investigated whether individuals with knee osteoarthritis have reduced ability to develop strength and power rapidly on top of reduced maximal strength capacities, which is the primary aim of the current study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older adults with knee osteoarthritis (>50 years) | – | Diagnostic Test: Muscle function test |
| Healthy older adults (> 50 years) | – | Diagnostic Test: Muscle function test |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between 50 and 80 years with or without knee osteoarthritis. Subjects are sedentary or recreationally active.
Key inclusion criteria (2 listed)
- Diagnosed with knee osteoarthritis based on RX.
Key exclusion criteria (12 listed)
- Systematic engagement in (resistance) exercise in the 12-months prior to participation
- Cardiovascular disease
- Neurological disorders
- Cognitive malfunctioning
- Severe knee or hip problems
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 testPower and strength tests of the knee-extensor muscles, handgrip strength, functional capacity tests | Diagnostic test | Healthy older adults (> 50 years), Older adults with knee osteoarthritis (>50 years) |
Primary outcome
Rate of power development
Time frame: up to 3 months
Subjects perform a test protocol on a Biodex dynamometer, consisting of isotonic contractions of the leg-extensor muscles. Subjects are instructed to kick as fast as possible against different (relative) loads. 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.
7 secondary outcomes
Maximal isometric strength
Time frame: up to 3 months
Maximal isokinetic strength
Time frame: up to 3 months
Stair Climbing performance
Time frame: up to 3 months
Gait speed
Time frame: up to 3 months
5 repetition sit-to-stand test
Time frame: up to 3 months
Timed-up-and-go
Time frame: up to 3 months
Handgrip strength
Time frame: up to 3 months
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 8 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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 Osteo Arthritis Knee, run by 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 2 inclusion and 12 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 8 Feb 2019. 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?
Rate of power development (time frame: up to 3 months). 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 8 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.