Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis

NCT04535596 | Completed

• 1 other identifier: 10840098-722.02-E.34224
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (OA) is a rheumatic disease that causes serious cartilage damage in the knee joint. Moderate physical activity can slow cartilage degeneration in moderate OA stages. Remarkable weakness and atrophy of the quadriceps and hamstrings is a common problem in patients with chronic osteoarthritis, but in arthritis, it may be difficult to achieve strength gains due to the pain caused by heavy load-resistant exercises. Exercising with these high loads may not be possible or may injure painful arthritic knees. For this reason, lately, blood flow restriction exercises have been directed to achieve the same gain by exercising with lower loads by restricting the blood flow with a cuff. We aimed to limit the blood flow in osteoarthritic knees and to provide strength gain and pain reduction provided by conventional exercises given routinely. Our hypothesis in this study is that exercises that blood flow restriction exercises will reduce pain and increase strength as well as conventional exercises.

Conditions

Osteoarthritis of Knee; Blood Flow Restriction Exercise; Resistance Training; Occlusion Training; Pain, Joint; Hypertrophy

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  Pain intensities which are assessed by visual analogue scale(VAS) divided 10 equal intervals. "0" means no pain and "10" means unbearable pain. Higher scores idicate worse pain intensity.

  12 weeks

• WOMAC score

  score among patients with knee and/or hip osteoarthritis. The Index is self-administered, 24 question, 5-point Likert. Scores range from 0 to 96 for the total WOMAC where higher scores indicate worse function.

  12 weeks

Secondary Outcomes (8)

• high sensitive C-reactive protein (hs-CRP)

  12 weeks

• Physical Function

  12 weeks

• Physical Function

  12 weeks

• Physical Function

  12 weeks

• Quadriceps muscle strength

  4 weeks

Study Arms (2)

Conventional Exercises

EXPERIMENTAL

12 week long strength training exercise with the higher loading (%70-80 of 1 Repetitive Maximum)

Other: Exercise

Blood Flof Restriction Exercises

EXPERIMENTAL

12 week long strength training exercise with the lower loading (%20-30 of 1 Repetitive Maximum) by using cuff around the thigh

Other: Exercise

Interventions

Exercise OTHER

12 week long strength training exercises for knee

Blood Flof Restriction Exercises; Conventional Exercises

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants between the ages of 45-70, diagnosed with knee osteoarthritis according to the criteria of the American College of Rheumatology.
• Participants who stated that the severity of knee pain to be evaluated with Visual Analog Pain Scale (VAS) is between 2-8
• Participants who are voluntaries for the study

You may not qualify if:

• Participants who have patellar subluxation or dislocation around the knee, who have other sources of knee pain such as bursae, fat pad and a history of knee surgery,
• Those who are in Grade 1 or 4 according to the Kellgren-Lawrence radiographic staging
• Those who have participated in leg weight exercise training in the last 6 months
• Participants who are under the high risk of venous thrombosis (lower extremity surgery, cardiovascular conditions including high blood pressure (\> 140/90) in the past 6 months),
• Diabetes, pregnancy, unexplained chest pain or heart disease, fainting or dizziness during physical activity / exercise.
• If exercise is contraindicated

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Gizem Ergezen

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthralgia; Hypertrophy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gizem Ergezen, MSc

  Medipol University

  PRINCIPAL INVESTIGATOR

• Mustafa Sahin, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

• Candan Algun, PhD

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gizem Ergezen, MSc, Physiotherapist

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 2, 2020
• Study Start: September 1, 2020
• Primary Completion: January 10, 2022
• Study Completion: February 11, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 3 months after publication

Locations

TU (1)