Back to resultsExercise With Blood Flow Restriction in Knee Osteoarthritis (BFROA)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
BFR resistance exercise
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Electromyography, Muscle Activity, Resistance Training
Eligibility Criteria
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.
Sites / Locations
- Clinic Universitary Hospital of Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Placebo
BFR at 40% AOP
BFR at 80% AOP
Arm Description
Knee extensions with 30% 1RM and no occlusion pressure.
Knee extensions with 30% 1RM and BFR at 40% AOP.
Knee extensions with 30% 1RM and BFR at 80% AOP.
Outcomes
Primary Outcome Measures
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.
Pressure pain thresholds
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
HDsEMG
Change between baseline and exercise, and the change between the treatment group and the placebo group.
Secondary Outcome Measures
Tampa Scale of Kinesiophobia (TSK 11)
Its score range is 11-44, with higher scores reflecting worse condition.
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.
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.
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.
Heart Rate
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05274932
Brief Title
Exercise With Blood Flow Restriction in Knee Osteoarthritis
Acronym
BFROA
Official Title
Neuromuscular Responses, Pain Intensity and Perceived Exertion of Resistance Exercise With Blood Flow Restriction in Patients With Severe Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Electromyography, Muscle Activity, Resistance Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Knee extensions with 30% 1RM and no occlusion pressure.
Arm Title
BFR at 40% AOP
Arm Type
Experimental
Arm Description
Knee extensions with 30% 1RM and BFR at 40% AOP.
Arm Title
BFR at 80% AOP
Arm Type
Experimental
Arm Description
Knee extensions with 30% 1RM and BFR at 80% AOP.
Intervention Type
Other
Intervention Name(s)
BFR resistance exercise
Intervention Description
4 sets (30, 15, 15, 15 reps).
Primary Outcome Measure Information:
Title
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Description
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
Time Frame
Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
Title
Pressure pain thresholds
Description
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
Time Frame
Pre exercise, immediate post session, and 10 minutes after session.
Title
HDsEMG
Description
Change between baseline and exercise, and the change between the treatment group and the placebo group.
Time Frame
During each experimental session and during each exercise condition.
Secondary Outcome Measure Information:
Title
Tampa Scale of Kinesiophobia (TSK 11)
Description
Its score range is 11-44, with higher scores reflecting worse condition.
Time Frame
Pre session.
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Pre session.
Title
Chronic Pain Self-Efficacy Scale (CPSS)
Description
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.
Time Frame
Pre session.
Title
WOMAC questionaire for patients with hip or knee osteoarthritis.
Description
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.
Time Frame
Pre session.
Title
Heart Rate
Description
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
Time Frame
Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
Title
Rating of perceived exertion (RPE) based on Borg's CR10 scale
Description
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.
Time Frame
Immediate post exercise.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Casaña
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joaquín Calatayud
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
Clinic Universitary Hospital of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise With Blood Flow Restriction in Knee Osteoarthritis
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