Exercise With Blood Flow Restriction in Knee Osteoarthritis (BFROA)

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: BFR resistance exercise

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Clinic Universitary Hospital of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Placebo; Knee extensions with 30% 1RM and no occlusion pressure.	Other: BFR resistance exercise; 4 sets (30, 15, 15, 15 reps).
EXPERIMENTAL: BFR at 40% AOP; Knee extensions with 30% 1RM and BFR at 40% AOP.	Other: BFR resistance exercise; 4 sets (30, 15, 15, 15 reps).
EXPERIMENTAL: BFR at 80% AOP; Knee extensions with 30% 1RM and BFR at 80% AOP.	Other: BFR resistance exercise; 4 sets (30, 15, 15, 15 reps).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)	Change from baseline to the end of the session, and the change between the treatment group and the placebo group.	Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
Pressure pain thresholds	Change from baseline to the end of the session, and the change between the treatment group and the placebo group.	Pre exercise, immediate post session, and 10 minutes after session.
HDsEMG	Change between baseline and exercise, and the change between the treatment group and the placebo group.	During each experimental session and during each exercise condition.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tampa Scale of Kinesiophobia (TSK 11)	Its score range is 11-44, with higher scores reflecting worse condition.	Pre session.
Pain Catastrophizing Scale (PCS)	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.	Pre session.
Chronic Pain Self-Efficacy Scale (CPSS)	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.	Pre session.
WOMAC questionaire for patients with hip or knee osteoarthritis.	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.	Pre session.
Heart Rate	Change from baseline to the end of the session, and the change between the treatment group and the placebo group.	Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
Rating of perceived exertion (RPE) based on Borg's CR10 scale	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.	Immediate post exercise.

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2022
• Primary Completion (ACTUAL): May 13, 2022
• Study Completion (ACTUAL): May 20, 2022

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: March 5, 2022
• First Posted (ACTUAL): March 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Electromyography; Knee Osteoarthritis; Resistance Training; Muscle Activity
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OA-22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No