Skip to main content
OpenTrials
Completed

NCT Number: NCT05274932

Exercise With Blood Flow Restriction in Knee Osteoarthritis

The purpose of this study is to evaluate the neuromuscular responses, pain intensity and rate of perceived exertion in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with blood flow restriction at different levels of arterial occlusion pressure.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic Universitary Hospital of Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men and women above 55 years old.
  • diagnosed with severe knee osteoarthritis.
  • scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.

Exclusion criteria

  • pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
  • another hip or knee joint replacement in the previous year.
  • any medical condition in which exercise was contraindicated.
  • participated in exercise programs (>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
  • history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.

Treatment and study plan

BFR resistance exercise

Other

4 sets (30, 15, 15, 15 reps).

Primary outcomes

  1. Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)

    Time frame: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.

    Change from baseline to the end of the session, and the change between the treatment group and the placebo group.

  2. Pressure pain thresholds

    Time frame: Pre exercise, immediate post session, and 10 minutes after session.

    Change from baseline to the end of the session, and the change between the treatment group and the placebo group.

  3. HDsEMG

    Time frame: During each experimental session and during each exercise condition.

    Change between baseline and exercise, and the change between the treatment group and the placebo group.

Secondary outcomes

  1. Tampa Scale of Kinesiophobia (TSK 11)

    Time frame: Pre session.

    Its score range is 11-44, with higher scores reflecting worse condition.

  2. Pain Catastrophizing Scale (PCS)

    Time frame: Pre session.

    People are asked to indicate the degree to which they have certain thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness, with higher scores reflecting worse condition.

  3. Chronic Pain Self-Efficacy Scale (CPSS)

    Time frame: Pre session.

    The Chronic Pain Self-Efficacy Scale (CPSS) is designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. The CPSS measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. A total score is yielded (ranging from 220-2200), with higher scores reflecting a better condition.

  4. WOMAC questionaire for patients with hip or knee osteoarthritis.

    Time frame: Pre session.

    The WOMAC is a disease-specific self-administered questionnaire for patients with hip or knee osteoarthritis. It has a multidimensional scale made up of 24 items grouped into three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). For each item, it uses a Likert scale with five response levels, representing different degrees of intensity (none, mild, moderate, severe or extreme) that are scored from 0 to 4. The final score for the WOMAC is determined by adding the aggregate scores for pain, stiffness and function. The higher the score, the worse the patient's condition.

  5. Heart Rate

    Time frame: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.

    Change from baseline to the end of the session, and the change between the treatment group and the placebo group.

  6. Rating of perceived exertion (RPE) based on Borg's CR10 scale

    Time frame: Immediate post exercise.

    The Borg CR10 scale is a tool for measuring an individual's effort and exertion during physical work. It is a very simple numerical list from 0 (no exertion at all) to 10 (maximal intensity of activity). Participants are asked to rate their exertion on the scale during the activity, combining all sensations and feelings of physical stress and fatigue. They are told to disregard any one factor such as leg pain or shortness of breath but to try to focus on the whole feeling of exertion.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Neuromuscular Responses, Pain Intensity and Perceived Exertion of Resistance Exercise With Blood Flow Restriction in Patients With Severe Knee Osteoarthritis

Acronym: BFROA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.