Exercise With Blood Flow Restriction in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— BFROA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05274932
• Other study ID #: OA-22-01
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 20, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• BFR resistance exercise
4 sets (30, 15, 15, 15 reps).

Locations

Country	Name	City	State
Spain	Clinic Universitary Hospital of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Tampa Scale of Kinesiophobia (TSK 11)	Its score range is 11-44, with higher scores reflecting worse condition.	Pre session.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.