Knee OsteoarthritisRTOANCT06664905
Resistance Exercise in Severe Knee Osteoarthritis
A study testing Resistance Exercise in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
Trial summary
This study aim to evaluate pain after different resistance training protocols (placebo, 4 sets of 10RM, 8 sets of 10 RM and 12 sets of 10RM) in patients with severe knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Resistance Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 10 Apr 2023to 5 Dec 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women at least 55 years old
- diagnosed with severe knee OA
- scheduled for unilateral Total Knee Arthroplasty (TKA) surgery
Who cannot join
- pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (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 study tasks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Different Resistance Training Protocols on Pain in Knee Osteoarthritis
This study aim to evaluate pain after different resistance training protocols (placebo, 4 sets of 10RM, 8 sets of 10 RM and 12 sets of 10RM) in patients with severe knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Resistance Exercise, Placebo
- Keywords
- Resistance Training, Knee Osteoarthritis, Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseOther
10 Repetition Maximum (RM)
PlaceboOther
Also called Control
No exercise
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | control, with no exercise Receives: Other: Placebo |
| 4 sets | Experimental | 4 sets of 10RM of knee extensions Receives: Other: Resistance Exercise |
| 8 sets | Experimental | 8 sets of 10RM of knee extensions Receives: Other: Resistance Exercise |
| 12 sets | Experimental | 12 sets of 10RM of knee extensions Receives: Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported pain intensity
Measure of knee pain intensity with the Visual Analogue Scale (0-100mm), with higher scores reflecting higher perceived pain intensity
Measured: Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
Change in pressure pain thresholds
Measured with a mechanical algometer (Wagner Instruments, Greenwich, CT, USA) in three sites (vastus medialis of the affected limb, vastus medialis of the unaffected limb, and distal to the non-dominant arm lateral epicondyle)
Measured: Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
Secondary outcomes (4)
WOMAC questionaire
A self-administered questionnaire for patients with hip or knee osteoarthritis. contain 24 items grouped into three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: pre-exercise
Tampa Scale of Kinesiophobia (TSK 11)
Measure fear of movement and its score ranges from 11-44 with higher scores indicate an increasing degree of kinesiophobia
Measured: pre-exercise
Chronic Pain Self-Efficacy Scale
Measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms management, physical functioning, and coping with symptomsmanagement, physical functioning, and coping with symptoms. A higher score suggests higher self-efficacy
Measured: pre-exercise
Pain Catastrophizing Scale
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-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start10 Apr 2023
- Primary completion10 May 2023
- Study completion5 Dec 2023
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.
- More trials run by University of ValenciaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664905
- Sponsor's protocol ID
- OA-2023
- Acronym
- RTOA
- Status last verified
- Oct 2024
- First submitted
- 14 Apr 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Resistance Training Protocols on Pain in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06664905
- Acronym / sponsor ID
- RTOA / OA-2023
- Conditions
- Knee Osteoarthritis
- Keywords
- Resistance Training, Knee Osteoarthritis, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 30 Oct 2024 (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.
This study aim to evaluate pain after different resistance training protocols (placebo, 4 sets of 10RM, 8 sets of 10 RM and 12 sets of 10RM) in patients with severe knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Other: Placebocontrol, with no exercise |
| 4 sets | Experimental | Other: Resistance Exercise4 sets of 10RM of knee extensions |
| 8 sets | Experimental | Other: Resistance Exercise8 sets of 10RM of knee extensions |
| 12 sets | Experimental | Other: Resistance Exercise12 sets of 10RM of knee extensions |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women at least 55 years old
- diagnosed with severe knee OA
- scheduled for unilateral Total Knee Arthroplasty (TKA) surgery
Key exclusion criteria (5 listed)
- pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (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 study 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 Exercise10 Repetition Maximum (RM) | Other | 12 sets, 4 sets, 8 sets |
| PlaceboAlso: ControlNo exercise | Other | Placebo |
Primary outcome
Change in self-reported pain intensity
Time frame: Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
Measure of knee pain intensity with the Visual Analogue Scale (0-100mm), with higher scores reflecting higher perceived pain intensity
Change in pressure pain thresholds
Time frame: Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
Measured with a mechanical algometer (Wagner Instruments, Greenwich, CT, USA) in three sites (vastus medialis of the affected limb, vastus medialis of the unaffected limb, and distal to the non-dominant arm lateral epicondyle)
4 secondary outcomes
WOMAC questionaire
Time frame: pre-exercise
Tampa Scale of Kinesiophobia (TSK 11)
Time frame: pre-exercise
Chronic Pain Self-Efficacy Scale
Time frame: pre-exercise
Pain Catastrophizing Scale
Time frame: pre-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 30 Oct 2024.
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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?
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 30 Oct 2024. 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?
Change in self-reported pain intensity (time frame: Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)). The study lists 2 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 30 Oct 2024.