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

NCT04819672 | Not Yet Recruiting

• 1 other identifier: PIBIC_Riccelli
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee; Ischemic Preconditioning; Exercise

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  8-week follow-up

Secondary Outcomes (9)

• Timed Up And Go Test (TUG-Test)

  4- and 8-weeks 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

• Assessment of strength of the quadriceps femoris using the isokinetic dynamometer

  4- and 8-weeks follow-up

• Numeric Pain Scale

  4-week and 6-month follow-up

Study Arms (2)

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.

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.

Other: Low Intensity Training associated with Partial Blood Flow-Sham

Interventions

Low Intensity Training associated with Partial Blood Flow OTHER

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

Low Intensity Training associated with Partial Blood Flow-Sham OTHER

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-Sham

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universidade Federal do Ceara: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 29, 2021
• Study Start: October 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06