Effect of Low Intensity Training Combined With Partial Restriction of Blood Flow in Individuals With Knee Osteoarthritis

June 2, 2024 updated by: Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • Diabetes type I or decompensated;
  • Peripheral vascular disease;
  • Uncontrolled hypertension;
  • History of deep vein thrombosis;
  • History of stroke;
  • History of cancer;
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Intensity Training associated with Partial Blood Flow
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.
Other: Low Intensity Training associated with Partial Blood Flow
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.
Sham Comparator: Low Intensity Training associated with Partial Blood Flow-Sham
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.
Other: Low Intensity Training associated with Partial Blood Flow-Sham
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8-week follow-up
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.
8-week follow-up
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.
8-week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed Up And Go Test (TUG-Test)
Time Frame: 4- and 8-weeks follow-up
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.
4- and 8-weeks follow-up
30 Seconds Chair Stand Test
Time Frame: 4- and 8- weeks follow-up
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.
4- and 8- weeks follow-up
Global Perceived Effect Scale
Time Frame: 4- and 8- weeks follow-up; and 6-month follow up
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.
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
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.
4- and 8-weeks follow-up
Numeric Pain Scale
Time Frame: 4-week and 6-month 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
4-week and 6-month follow-up
Pain subscale - Knee Injury and Osteoarthritis Outcome Score
Time Frame: 4-week and 6-month follow-up
Pain subscale - KOOS was assessed, where 0 corresponded to no pain and 100 corresponded to worst pain.
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
Activities of daily living subscale - KOOS was assessed, where 0 corresponded to normal function and 100 corresponded to worst function.
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
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.
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
The amount of non-hormonal anti-inflammatory drugs and/or painkillers will be counted as clinical outcomes in all assessments.
4- and 8-weeks follow-up; and 6-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Ceara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIBIC_Riccelli

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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