Knee OsteoarthritisDTOANCT05280080
Exercise With Dual Task in Knee Osteoarthritis
A study testing Resistance exercise in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the neuromuscular and perceptual responses, pain intensity and performance in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with a self-regulated mathematical dual-task. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2022to 20 May 2022
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women above 55 years old.
- diagnosed with severe knee osteoarthritis.
- scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.
Who cannot join
- pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
- another hip or knee joint replacement in the previous year.
- any medical condition in which exercise was contraindicated.
- participated in exercise programs (>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
- history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular and Perceptual Responses, Pain Intensity and Performance During Resistance Exercise With a Self-regulated Dual-task in Patients With Severe Knee Osteoarthritis
The purpose of this study is to evaluate the neuromuscular and perceptual responses, pain intensity and performance in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with a self-regulated mathematical dual-task.
- Conditions
- Knee Osteoarthritis
- Being tested
- Resistance exercise
- Keywords
- Knee Osteoarthritis, Electromyography, Muscle Activity, Resistance Training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
Do the maximum number of repetitions of externally-resisted (50% 1RM) knee extensions.
| Study group | Role | What they receive |
|---|---|---|
| Regular Task | Active comparator | Knee extensions. Receives: Other: Resistance exercise |
| Dual Task | Experimental | Knee extensions while also doing a self-regulated mathematical dual-task. Receives: Other: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Change from baseline to the end of the session, and the change between the dual-task and the regular condition.
Measured: Pre exercise, immediate post session, and 10 minutes after session.
Pressure pain thresholds
Change from baseline to the end of the session, and the change between the dual-task and the regular condition.
Measured: Pre exercise, immediate post session, and 10 minutes after session.
HDsEMG
Change from baseline to the end of the session, and the change between the dual-task and the regular condition.
Measured: During each experimental session and during each exercise condition.
Performance
Maximum number of exercise repetitions performed.
Measured: During each experimental session and during each exercise condition.
Secondary outcomes (6)
Tampa Scale of Kinesiophobia (TSK 11)
Its score range is 11-44, with higher scores reflecting worse condition.
Measured: Pre session.
Pain Catastrophizing Scale (PCS)
People are asked to indicate the degree to which they have certain thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness, with higher scores reflecting worse condition.
Measured: Pre session.
Chronic Pain Self-Efficacy Scale (CPSS)
The Chronic Pain Self-Efficacy Scale (CPSS) is designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. The CPSS measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. A total score is yielded (ranging from 220-2200), with higher scores reflecting a better condition.
Measured: Pre session.
WOMAC questionaire for patients with hip or knee osteoarthritis.
The WOMAC is a disease-specific self-administered questionnaire for patients with hip or knee osteoarthritis. It has a multidimensional scale made up of 24 items grouped into three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). For each item, it uses a Likert scale with five response levels, representing different degrees of intensity (none, mild, moderate, severe or extreme) that are scored from 0 to 4. The final score for the WOMAC is determined by adding the aggregate scores for pain, stiffness and function. The higher the score, the worse the patient's condition.
Measured: Pre session.
Heart Rate
Change from baseline to the end of the session, and the change between the dual-task and the regular condition.
Measured: Pre exercise, immediate post session, and 10 minutes after session.
Perceived difficulty of the dual-task.
Based on an 11-point numerical rating scale.
Measured: Immediate post exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start21 Mar 2022
- Primary completion13 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Casaña Granell, University of Valencia
- Investigators
- José Casaña, Principal investigator, University of ValenciaJoaquín Calatayud, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280080
- Sponsor's protocol ID
- OA-22-02
- Acronym
- DTOA
- Status last verified
- May 2022
- First submitted
- 15 Feb 2022
- Last updated
- 24 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 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular and Perceptual Responses, Pain Intensity and Performance During Resistance Exercise With a Self-regulated Dual-task in Patients With Severe Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05280080
- Acronym / sponsor ID
- DTOA / OA-22-02
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Electromyography, Muscle Activity, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 15 Mar 2022 (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 purpose of this study is to evaluate the neuromuscular and perceptual responses, pain intensity and performance in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with a self-regulated mathematical dual-task.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Task | Active comparator | Other: Resistance exerciseKnee extensions. |
| Dual Task | Experimental | Other: Resistance exerciseKnee extensions while also doing a self-regulated mathematical dual-task. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women above 55 years old.
- diagnosed with severe knee osteoarthritis.
- scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.
Key exclusion criteria (5 listed)
- pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
- another hip or knee joint replacement in the previous year.
- any medical condition in which exercise was contraindicated.
- participated in exercise programs (>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
- history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.
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 |
|---|---|---|
| Resistance exerciseDo the maximum number of repetitions of externally-resisted (50% 1RM) knee extensions. | Other | Dual Task, Regular Task |
Primary outcome
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Time frame: Pre exercise, immediate post session, and 10 minutes after session.
Change from baseline to the end of the session, and the change between the dual-task and the regular condition.
Pressure pain thresholds
Time frame: Pre exercise, immediate post session, and 10 minutes after session.
Change from baseline to the end of the session, and the change between the dual-task and the regular condition.
HDsEMG
Time frame: During each experimental session and during each exercise condition.
Change from baseline to the end of the session, and the change between the dual-task and the regular condition.
Performance
Time frame: During each experimental session and during each exercise condition.
Maximum number of exercise repetitions performed.
6 secondary outcomes
Tampa Scale of Kinesiophobia (TSK 11)
Time frame: Pre session.
Pain Catastrophizing Scale (PCS)
Time frame: Pre session.
Chronic Pain Self-Efficacy Scale (CPSS)
Time frame: Pre session.
WOMAC questionaire for patients with hip or knee osteoarthritis.
Time frame: Pre session.
Heart Rate
Time frame: Pre exercise, immediate post session, and 10 minutes after session.
Perceived difficulty of the dual-task.
Time frame: Immediate post exercise.
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 24 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.
José Casaña principal investigator
University of Valencia
Joaquín Calatayud study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
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 3 inclusion and 5 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 24 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 Spain. 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?
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10) (time frame: Pre exercise, immediate post session, and 10 minutes after session.). The study lists 4 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 24 May 2022.