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Clinical Trials/NCT04819672
NCT04819672
Not yet recruiting
Not Applicable

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

Universidade Federal do Ceara0 sites66 target enrollmentOctober 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Universidade Federal do Ceara
Enrollment
66
Primary Endpoint
Pain subscale - Knee Injury and Osteoarthritis Outcome Score
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2024
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gabriel Peixoto Leão Almeida

PhD

Universidade Federal do Ceara

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Numeric Pain Scale(4-week and 6-month follow-up)
  • Assessment of strength of the quadriceps femoris using the isokinetic dynamometer(4- and 8-weeks follow-up)
  • Activities of daily living subscale - Knee Injury and Osteoarthritis Outcome Score(4-week and 6-month follow-up)
  • Timed Up And Go Test (TUG-Test)(4- and 8-weeks follow-up)
  • Pain subscale - Knee Injury and Osteoarthritis Outcome Score(4-week and 6-month follow-up)
  • 30 Seconds Chair Stand Test(4- and 8- weeks follow-up)
  • Global Perceived Effect Scale(4- and 8- weeks follow-up; and 6-month follow up)
  • Others subscales - Knee Injury and Osteoarthritis Outcome Score(4- and 8-weeks follow-up; and 6-month follow up)
  • Amount of non-hormonal anti-inflammatory and/or analgesics ingested(4- and 8-weeks follow-up; and 6-month follow up)

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