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

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Intensity Training associated with Partial Blood Flow
Low Intensity Training associated with Partial Blood Flow-Sham
Sponsored by
Universidade Federal do Ceara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Ischemic Preconditioning, Exercise

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Low Intensity Training associated with Partial Blood Flow

    Low Intensity Training associated with Partial Blood Flow-Sham

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    March 23, 2021
    Last Updated
    March 25, 2021
    Sponsor
    Universidade Federal do Ceara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04819672
    Brief Title
    Effect of Low Intensity Training Combined With Partial Restriction of Blood Flow in Individuals With Knee Osteoarthritis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    August 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Ceara

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    Osteoarthritis, Knee, Ischemic Preconditioning, Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low Intensity Training associated with Partial Blood Flow
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Low Intensity Training associated with Partial Blood Flow-Sham
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Low Intensity Training associated with Partial Blood Flow
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Low Intensity Training associated with Partial Blood Flow-Sham
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain subscale - Knee Injury and Osteoarthritis Outcome Score
    Description
    Pain subscale - KOOS was assessed, where 0 corresponded to no pain and 100 corresponded to worst pain.
    Time Frame
    8-week follow-up
    Title
    Activities of daily living subscale - Knee Injury and Osteoarthritis Outcome Score
    Description
    Activities of daily living subscale - KOOS was assessed, where 0 corresponded to normal function and 100 corresponded to worst function.
    Time Frame
    8-week follow-up
    Title
    Numeric Pain Scale
    Description
    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.
    Time Frame
    8-week follow-up
    Secondary Outcome Measure Information:
    Title
    Timed Up And Go Test (TUG-Test)
    Description
    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.
    Time Frame
    4- and 8-weeks follow-up
    Title
    30 Seconds Chair Stand Test
    Description
    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.
    Time Frame
    4- and 8- weeks follow-up
    Title
    Global Perceived Effect Scale
    Description
    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.
    Time Frame
    4- and 8- weeks follow-up; and 6-month follow up
    Title
    Assessment of strength of the quadriceps femoris using the isokinetic dynamometer
    Description
    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.
    Time Frame
    4- and 8-weeks follow-up
    Title
    Numeric Pain Scale
    Description
    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
    Time Frame
    4-week and 6-month follow-up
    Title
    Pain subscale - Knee Injury and Osteoarthritis Outcome Score
    Description
    Pain subscale - KOOS was assessed, where 0 corresponded to no pain and 100 corresponded to worst pain.
    Time Frame
    4-week and 6-month follow-up
    Title
    Activities of daily living subscale - Knee Injury and Osteoarthritis Outcome Score
    Description
    Activities of daily living subscale - KOOS was assessed, where 0 corresponded to normal function and 100 corresponded to worst function.
    Time Frame
    4-week and 6-month follow-up
    Title
    Others subscales - Knee Injury and Osteoarthritis Outcome Score
    Description
    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.
    Time Frame
    4- and 8-weeks follow-up; and 6-month follow up
    Title
    Amount of non-hormonal anti-inflammatory and/or analgesics ingested
    Description
    The amount of non-hormonal anti-inflammatory drugs and/or painkillers will be counted as clinical outcomes in all assessments.
    Time Frame
    4- and 8-weeks follow-up; and 6-month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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