Osteoarthritis, KneeNCT04819672
Effect of Low Intensity Training Combined With Partial Restriction of Blood Flow in Individuals With Knee Osteoarthritis
A study testing Low Intensity Training associated with Partial Blood Flow in people with Osteoarthritis, Knee, run by Universidade Federal do Ceara.
Trial summary
Osteoarthritis (OA) is a chronic degenerative infection that presents clinical features such as pain and limited range of motion. A weakness of the quadriceps makes this joint more susceptible to wear and tear to the articular cartilage, especially in the medial compartment of the knee. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Low Intensity Training associated with Partial Blood Flow
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2024to Dec 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of clinical diagnosis of osteoarthritis according to the criteria established by the American College of Rheumatology;
- OA knee radiograph grades 2 - 4 according to the Kellgren-Lawrence scale;
- Reporting knee pain with minimum intensity of 3 on Numerical Pain Scale;
- Complaints of pain and functional reduction in the last three months;
Who cannot join
- Diabetes type I or decompensated;
- Peripheral vascular disease;
- Uncontrolled hypertension;
- History of deep vein thrombosis;
- History of stroke;
- History of cancer;
Show all 17Show fewer
- Cardiac pacemaker;
- Cognitive disorders;
- Neurological deficits (sensory or motor)
- Body mass index above 40 kg/m2
- Hip symptomatic osteoarthritis
- Low back pain
- Use of painkillers in the last 24 hours;
- Intra-articular infiltration with hyaluronic acid and corticosteroids in the last 6 months;
- Orthopedic surgery on lower limbs;
- Systemic inflammatory disease;
- Not able to walk
About this study
Official title: Effect of Low Intensity Resistance Training Combined With Partial Blood Flow Restriction on Pain and Function in Individuals With Knee Osteoarthritis: a Randomized Controlled Study
Osteoarthritis (OA) is a chronic degenerative infection that presents clinical features such as pain and limited range of motion. A weakness of the quadriceps makes this joint more susceptible to wear and tear to the articular cartilage, especially in the medial compartment of the knee. As a result, it is necessary to promote an increase of at least 30% in quadriceps strength for a beneficial effect on pain and 40% in functional capacity. Therapeutic exercises are used to increase strength muscle, in addition to high intensity exercises, to decrease joint pain, low to moderate intensity resistance training has been included, with the new approach of using partial blood flow restriction.
Read the detailed description
Physical therapy sessions will be individual and supervised, will last 30-40 minutes, twice a week, for eight weeks.
Participants will warm up with a walk or bike for 5 minutes. Then, a single series of sustained stretching will be performed for a period of 40 seconds for the following muscle groups: hamstrings, quadriceps femoris, hip abductors, hip adductors and gastrocnemius. After the stretches, active muscle strengthening exercises will be performed focusing on the quadriceps femoris muscle. The knee extension and squat exercises will be performed in four sets, with the first set being thirty repetitions or even volitional fatigue, and the following three sets will be fifteen to twenty-four repetitions, with 90 seconds of rest between each series, and two minutes of rest at the end of the four series. Both groups will perform these exercises with 30% of 1RM. The maximum load that will be lifted until volitional fatigue between 7 to 10 repetitions will be used instead of direct 1RM measurement.
Regarding the intensity of the exercises, this will be monitored by the physical therapist according to the perception of the level of effort and difficulty reported by the participant when completing the series of knee extension and squat, according to the specifications of the modified Borg scale (CR-10) . The exercises will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant. The load will be increased by 2-10% when the patient is able to perform 24 complete repetitions in the last series of the exercise with perceived effort <60%. During the exercises, a metronome will be used for the time under tension, 2 seconds for the eccentric and concentric phase.
Partial blood flow restriction will be used during knee extension and squat exercises as follows: Arterial occlusion pressure will be measured by placing a cuff on the proximal thigh in a standing position. The measurement of insufflation for each patient will be established as follows: with the participant in the supine position, the pulse of the pedal will be located with the LOGIQ e (GE Healthcare) Ultrasound. The cuff pressure will be increased until the pedal pulse can no longer be identified, and then the arterial occlusion pressure will be recorded when the pulse is restored. The RPFS will be performed at 60% of the arterial occlusion pressure for the experimental group and there will be no arterial occlusion pressure for the sham group.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Low Intensity Training associated with Partial Blood Flow, Low Intensity Training associated with Partial Blood Flow-Sham
- Keywords
- Osteoarthritis, Knee, Ischemic Preconditioning, Exercise
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Training associated with Partial Blood FlowOther
16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps, hamstrings, sural triceps, abductors and adductors of the hip. The Partial blood flow restriction will be used during knee extension and squat exercises. During the exercises, a metronome will be used for the time under tension, 2 seconds for the eccentric and concentric phase.
Low Intensity Training associated with Partial Blood Flow-ShamOther
16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps, hamstrings, sural triceps, abductors and adductors of the hip. The Partial blood flow restriction will be used during knee extension and squat exercises. During the exercises, a metronome will be used for the time under tension, 2 seconds for the eccentric and concentric phase.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Training associated with Partial Blood Flow | Experimental | In the experimental group, a cuff with compression at 60% of the pressure required for total arterial occlusion will be placed, 16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps (knee extension and squat). The cuff with partial blood flow restriction will be used during knee extension and squat exercises. Receives: Other: Low Intensity Training associated with Partial Blood Flow |
| Low Intensity Training associated with Partial Blood Flow-Sham | Sham comparator | In the sham group, the cuff will be placed, but there will be no arterial occlusion pressure, 16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps (knee extension and squat). The cuff without partial blood flow restriction will be used during knee extension and squat exercises. Receives: Other: Low Intensity Training associated with Partial Blood Flow-Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain subscale - Knee Injury and Osteoarthritis Outcome Score
Pain subscale - KOOS was assessed, where 0 corresponded to no pain and 100 corresponded to worst pain.
Measured: 8-week follow-up
Activities of daily living subscale - Knee Injury and Osteoarthritis Outcome Score
Activities of daily living subscale - KOOS was assessed, where 0 corresponded to normal function and 100 corresponded to worst function.
Measured: 8-week follow-up
Numeric Pain Scale
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain.
Measured: 8-week follow-up
Secondary outcomes (9)
Timed Up And Go Test (TUG-Test)
This test quantifies the functional capacity in seconds by the time the individual needs to perform the task of getting up from a chair with a backrest without the aid of arms, walking three meters, turning, going back to the chair and sitting again, wearing regular shoes and without walking assist devices. A tape will be used to mark the distance of three meters. The patient will perform a practical test and two effective tests, assuming the shortest time for statistical analysis.
Measured: 4- and 8-weeks follow-up
30 Seconds Chair Stand Test
This test quantifies the maximum number of repetitions that the individual is able to get up and sit without using the armrest in a 44 cm chair in a period of 30 seconds. The patient must have his arms crossed over his chest and his feet at the shoulder line to perform the test.
Measured: 4- and 8- weeks follow-up
Global Perceived Effect Scale
Scale of 11 points ranging from minus five points (extremely worse), zero (no change) to five points (completely recovered). For all measures of the perceived global effect, participants will be asked: "compared to starting treatment, how would you describe your knee today?". Positive scores represent better recovery, negative scores indicate worsening of symptoms and zero without change.
Measured: 4- and 8- weeks follow-up; and 6-month follow up
Assessment of strength of the quadriceps femoris using the isokinetic dynamometer
Strength assessment will be measured by the Isokinetic Dynamometer by a blind assessor. The positioning will be carried out as follows: when seated in the chair, the popliteal fossa will be positioned 2 cm from the end of the seat, the hip positioned at 85 ° of flexion, the axis of movement of the device was aligned with the intercondylar line of the knee, and the lever arm kept 2 cm above the lateral malleolus. Belts will be placed to stabilize the trunk, abdomen and thigh of the evaluated member. After that, the limits of maximum range of motion and flexion will be established, the adequacy of the initial knee position at 90° of flexion and the weighing of the lower limb to be evaluated. The participant will be registered in the device system, with information such as dominance and limb injury. The protocol that will be used involves five concentric repetitions with maximum intensity at 60 °/s for strength assessment.
Measured: 4- and 8-weeks follow-up
Numeric Pain Scale
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain
Measured: 4-week and 6-month follow-up
Pain subscale - Knee Injury and Osteoarthritis Outcome Score
Pain subscale - KOOS was assessed, where 0 corresponded to no pain and 100 corresponded to worst pain.
Measured: 4-week and 6-month follow-up
Activities of daily living subscale - Knee Injury and Osteoarthritis Outcome Score
Activities of daily living subscale - KOOS was assessed, where 0 corresponded to normal function and 100 corresponded to worst function.
Measured: 4-week and 6-month follow-up
Others subscales - Knee Injury and Osteoarthritis Outcome Score
It contains 42 items, divided into five subscales: other symptoms (7 questions), function in sport (5 questions) and recreation and quality of life related to the knee (4 questions) ). Its score ranges from 0 (extreme problem) to 100 (without problems) separately within each subscale.
Measured: 4- and 8-weeks follow-up; and 6-month follow up
Amount of non-hormonal anti-inflammatory and/or analgesics ingested
The amount of non-hormonal anti-inflammatory drugs and/or painkillers will be counted as clinical outcomes in all assessments.
Measured: 4- and 8-weeks follow-up; and 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start5 Oct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819672
- Sponsor's protocol ID
- PIBIC_Riccelli
- Status last verified
- Jun 2024
- First submitted
- 23 Mar 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Intensity Resistance Training Combined With Partial Blood Flow Restriction on Pain and Function in Individuals With Knee Osteoarthritis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04819672
- Acronym / sponsor ID
- PIBIC_Riccelli
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Ischemic Preconditioning, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- 5 Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Mar 2021 (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.
Osteoarthritis (OA) is a chronic degenerative infection that presents clinical features such as pain and limited range of motion. A weakness of the quadriceps makes this joint more susceptible to wear and tear to the articular cartilage, especially in the medial compartment of the knee. As a result, it is necessary to promote an increase of at least 30% in quadriceps strength for a beneficial effect on pain and 40% in functional capacity. Therapeutic exercises are used to increase strength muscle, in addition to high intensity exercises, to decrease joint pain, low to moderate intensity resistance training has been included, with the new approach of using partial blood flow restriction.
Detailed description
Physical therapy sessions will be individual and supervised, will last 30-40 minutes, twice a week, for eight weeks.
Participants will warm up with a walk or bike for 5 minutes. Then, a single series of sustained stretching will be performed for a period of 40 seconds for the following muscle groups: hamstrings, quadriceps femoris, hip abductors, hip adductors and gastrocnemius. After the stretches, active muscle strengthening exercises will be performed focusing on the quadriceps femoris muscle. The knee extension and squat exercises will be performed in four sets, with the first set being thirty repetitions or even volitional fatigue, and the following three sets will be fifteen to twenty-four repetitions, with 90 seconds of rest between each series, and two minutes of rest at the end of the four series. Both groups will perform these exercises with 30% of 1RM. The maximum load that will be lifted until volitional fatigue between 7 to 10 repetitions will be used instead of direct 1RM measurement.
Regarding the intensity of the exercises, this will be monitored by the physical therapist according to the perception of the level of effort and difficulty reported by the participant when completing the series of knee extension and squat, according to the specifications of the modified Borg scale (CR-10) . The exercises will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant. The load will be increased by 2-10% when the patient is able to perform 24 complete repetitions in the last series of the exercise with perceived effort <60%. During the exercises, a metronome will be used for the time under tension, 2 seconds for the eccentric and concentric phase.
Partial blood flow restriction will be used during knee extension and squat exercises as follows: Arterial occlusion pressure will be measured by placing a cuff on the proximal thigh in a standing position. The measurement of insufflation for each patient will be established as follows: with the participant in the supine position, the pulse of the pedal will be located with the LOGIQ e (GE Healthcare) Ultrasound. The cuff pressure will be increased until the pedal pulse can no longer be identified, and then the arterial occlusion pressure will be recorded when the pulse is restored. The RPFS will be performed at 60% of the arterial occlusion pressure for the experimental group and there will be no arterial occlusion pressure for the sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Training associated with Partial Blood Flow | Experimental | Other: Low Intensity Training associated with Partial Blood FlowIn the experimental group, a cuff with compression at 60% of the pressure required for total arterial occlusion will be placed, 16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps (knee extension and squat). The cuff with partial blood flow restriction will be used during knee extension and squat exercises. |
| Low Intensity Training associated with Partial Blood Flow-Sham | Sham comparator | Other: Low Intensity Training associated with Partial Blood Flow-ShamIn the sham group, the cuff will be placed, but there will be no arterial occlusion pressure, 16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps (knee extension and squat). The cuff without partial blood flow restriction will be used during knee extension and squat exercises. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmation of clinical diagnosis of osteoarthritis according to the criteria established by the American College of Rheumatology;
- OA knee radiograph grades 2 - 4 according to the Kellgren-Lawrence scale;
- Reporting knee pain with minimum intensity of 3 on Numerical Pain Scale;
- Complaints of pain and functional reduction in the last three months;
Key exclusion criteria (17 listed)
- Diabetes type I or decompensated;
- Peripheral vascular disease;
- Uncontrolled hypertension;
- History of deep vein thrombosis;
- History of stroke;
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 |
|---|---|---|
| Low Intensity Training associated with Partial Blood Flow16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps, hamstrings, sural triceps, abductors and adductors of the hip. The Partial blood flow restriction will be used during knee extension and squat exercises. During the exercises, a metronome will be used for the time under tension, 2 seconds for the eccentric and concentric phase. | Other | Low Intensity Training associated with Partial Blood Flow |
| Low Intensity Training associated with Partial Blood Flow-Sham16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps, hamstrings, sural triceps, abductors and adductors of the hip. The Partial blood flow restriction will be used during knee extension and squat exercises. During the exercises, a metronome will be used for the time under tension, 2 seconds for the eccentric and concentric phase. | Other | Low Intensity Training associated with Partial Blood Flow-Sham |
Primary outcome
Pain subscale - Knee Injury and Osteoarthritis Outcome Score
Time frame: 8-week follow-up
Pain subscale - KOOS was assessed, where 0 corresponded to no pain and 100 corresponded to worst pain.
Activities of daily living subscale - Knee Injury and Osteoarthritis Outcome Score
Time frame: 8-week follow-up
Activities of daily living subscale - KOOS was assessed, where 0 corresponded to normal function and 100 corresponded to worst function.
Numeric Pain Scale
Time frame: 8-week follow-up
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain.
9 secondary outcomes
Timed Up And Go Test (TUG-Test)
Time frame: 4- and 8-weeks follow-up
30 Seconds Chair Stand Test
Time frame: 4- and 8- weeks follow-up
Global Perceived Effect Scale
Time frame: 4- and 8- weeks follow-up; and 6-month follow up
Assessment of strength of the quadriceps femoris using the isokinetic dynamometer
Time frame: 4- and 8-weeks follow-up
Numeric Pain Scale
Time frame: 4-week and 6-month follow-up
Pain subscale - Knee Injury and Osteoarthritis Outcome Score
Time frame: 4-week and 6-month follow-up
Activities of daily living subscale - Knee Injury and Osteoarthritis Outcome Score
Time frame: 4-week and 6-month follow-up
Others subscales - Knee Injury and Osteoarthritis Outcome Score
Time frame: 4- and 8-weeks follow-up; and 6-month follow up
Amount of non-hormonal anti-inflammatory and/or analgesics ingested
Time frame: 4- and 8-weeks follow-up; and 6-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Training associated with Partial Blood Flow in people with Osteoarthritis, Knee, run by Universidade Federal do Ceara.
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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Pain subscale - Knee Injury and Osteoarthritis Outcome Score (time frame: 8-week follow-up). The study lists 3 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 4 Jun 2024.