Osteoarthritis of the KneeNCT04600661
LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
A study testing Traditional exercise therapy in people with Osteoarthritis of the Knee, run by Mai Mohamed Abdelkader Abdallah.
Trial summary
This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Traditional exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 15 Sep 2021
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range from 45-60 years (Segal et al., 2015).
- Walk with painful knee OA without assistive devices (Bryk et al., 2016).
- Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016).
- BMI < 30 kg/m² (not being classified as obese) (Bryk et al., 2016).
- Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008)
Who cannot join
- Severe knee OA (grade IV according to K/L classification).
- Bilateral knee OA.
- Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
- Repeated treatment with steroids.
- Secondary knee OA.
- Received joint replacement surgery in either Knee or/and hip.
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- Cardiovascular and neuromuscular disorders
- Diabetic patients
- Psychiatric disorders.
Trial locations and contacts
No sites are listed yet.
About this study
This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.
Read the detailed description
PURPOSE:
This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.
BACKGROUND:
Patients with knee OA may have reduction of tolerance of the high-load programs which is recommended for eliciting strength gains (Messier et al., 2013). Thus, for reducing disease risk and enhancing physical function, there is a need for effectively strengthening the quadriceps muscle while limiting pain and adverse joint loading in people with knee OA (Segal et al., 2015). Blood flow restriction (BFR) with low-load resistance training (LLRT) is an alternative to traditional strength training that can be used in knee OA with minimal adverse joint loading that is normally found in traditional strengthening programs(Pope et al., 2013). It is attained through applying pressure externally with a pneumatic cuff or tourniquet. The applied pressure occludes venous outflow while maintaining arterial inflow with intent to promote blood pooling in the capillary beds of the limb muscles distal to the tourniquet (Slysz et al., 2016). Kubota et al., (2008), showed that BFR can be applied during periods of immobilization to decrease disuse muscle atrophy of limbs. Also it can be combined with exercise which enhances muscular development. Resistance exercise appears to provide great muscular gains when combined with BFR (Slysz et al., 2016).
HYPOTHESES:
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving quadriceps muscle strength using HHD in patients with unilateral knee OA.
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint function on WOMAC questionnaire in patients with unilateral knee OA.
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint proprioception in patients with unilateral knee OA.
RESEARCH QUESTION:
Does blood flow restriction with low load resistance training and neuromuscular training have a significant effect over traditional rehabilitation protocol (stretching and strengthening for hip and knee muscles) on quadriceps muscle strength, knee joint function and proprioception accuracy in patients with unilateral knee OA?
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Traditional exercise therapy
- Keywords
- Blood flow restriction 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.
Traditional exercise therapyOther
Also called Blood flow restriction training
Neuromuscular training
| Study group | Role | What they receive |
|---|---|---|
| control group (Traditional therapy group) | Experimental | control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training Receives: Other: Traditional exercise therapy |
| Experimental group I (BFR training group) | Experimental | Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR. Receives: Other: Traditional exercise therapy |
| Experimental group II (Neuromuscular training group) | Experimental | Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises Receives: Other: Traditional exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Hand-Held Dynamometer for measuring muscle strength
Measured: 3 months
Secondary outcomes (1)
Knee joint function
Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start15 Jan 2021 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the 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
- Model description
- Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training) Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR. Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mai Mohamed Abdelkader Abdallah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mai Mohamed Abdelkader Abdallah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600661
- Sponsor's protocol ID
- 012/002777
- Status last verified
- Jun 2020
- First submitted
- 19 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.
PubMed 26971109
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
- ClinicalTrials.gov ID
- NCT04600661
- Acronym / sponsor ID
- 012/002777
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Blood flow restriction training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Mai Mohamed Abdelkader AbdallahUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 23 Oct 2020 (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 will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.
Detailed description
PURPOSE:
This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.
BACKGROUND:
Patients with knee OA may have reduction of tolerance of the high-load programs which is recommended for eliciting strength gains (Messier et al., 2013). Thus, for reducing disease risk and enhancing physical function, there is a need for effectively strengthening the quadriceps muscle while limiting pain and adverse joint loading in people with knee OA (Segal et al., 2015). Blood flow restriction (BFR) with low-load resistance training (LLRT) is an alternative to traditional strength training that can be used in knee OA with minimal adverse joint loading that is normally found in traditional strengthening programs(Pope et al., 2013). It is attained through applying pressure externally with a pneumatic cuff or tourniquet. The applied pressure occludes venous outflow while maintaining arterial inflow with intent to promote blood pooling in the capillary beds of the limb muscles distal to the tourniquet (Slysz et al., 2016). Kubota et al., (2008), showed that BFR can be applied during periods of immobilization to decrease disuse muscle atrophy of limbs. Also it can be combined with exercise which enhances muscular development. Resistance exercise appears to provide great muscular gains when combined with BFR (Slysz et al., 2016).
HYPOTHESES:
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving quadriceps muscle strength using HHD in patients with unilateral knee OA.
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint function on WOMAC questionnaire in patients with unilateral knee OA.
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint proprioception in patients with unilateral knee OA.
RESEARCH QUESTION:
Does blood flow restriction with low load resistance training and neuromuscular training have a significant effect over traditional rehabilitation protocol (stretching and strengthening for hip and knee muscles) on quadriceps muscle strength, knee joint function and proprioception accuracy in patients with unilateral knee OA?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training) Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR. Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises
| Arm | Type | Receives |
|---|---|---|
| control group (Traditional therapy group) | Experimental | Other: Traditional exercise therapycontrol group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training |
| Experimental group I (BFR training group) | Experimental | Other: Traditional exercise therapyExperimental group I (BFR training group) (n=21): patients will receive LLRT with BFR. |
| Experimental group II (Neuromuscular training group) | Experimental | Other: Traditional exercise therapyExperimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range from 45-60 years (Segal et al., 2015).
- Walk with painful knee OA without assistive devices (Bryk et al., 2016).
- Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016).
- BMI < 30 kg/m² (not being classified as obese) (Bryk et al., 2016).
- Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008)
Key exclusion criteria (9 listed)
- Severe knee OA (grade IV according to K/L classification).
- Bilateral knee OA.
- Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
- Repeated treatment with steroids.
- Secondary knee OA.
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 |
|---|---|---|
| Traditional exercise therapyAlso: Blood flow restriction trainingNeuromuscular training | Other | Experimental group I (BFR training group), Experimental group II (Neuromuscular training group), control group (Traditional therapy group) |
Primary outcome
Muscle strength
Time frame: 3 months
Hand-Held Dynamometer for measuring muscle strength
1 secondary outcome
Knee joint function
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Background: PubMed 26971109Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional exercise therapy in people with Osteoarthritis of the Knee, run by Mai Mohamed Abdelkader Abdallah.
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 5 inclusion and 9 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 23 Oct 2020. 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. 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?
Contact Mai M Abdelkader (+201094355573, mai.abdelkader@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600661, which also lists 1 linked publication.
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 23 Oct 2020.