NCT05781230|Completed
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Sponsor study identifier
interventional
38
1 country
1
Study Start
January 1, 2022
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so, if it changes with exercise intensity. A repeated measures and single-blinded randomized study were done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted for five days during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2022
Actual (reported)April 30, 2022
Actual (reported)May 1, 2022
Actual (reported)February 24, 2023
Actual (reported)March 23, 2023
Actual (reported)change of pain severity
. The pain severity evaluated using a visual analogue scale (VAS; scored from 0, no pain, to 100, the worst pain ever).
admission to hospital service to discharge from hospital service, an average 5 days
Change of Pressure pain theshold
Pressure pain threshold (PPTs) were assessed using a handheld pressure algo-meter
admission to hospital service to discharge from hospital service, an average 5 days
HIE program ; High Intensity Exercises Program. 3 sets of 15 repetition
Low Intensity Exercises program 2 sets of 8 repetition
HIE program consisted of ankle pump exercise, Quadriceps isometric exercise, Terminal extension exercise, Passive-active assistive-active range of motion exercise, Heel sliding exercise, Straight leg raise exercise. All exercises were performed for 3 sets of 15 repetitions.
Merve Karapinar
Isparta, Turkey (Türkiye)
MERVE KARAPINAR, PT
RESEARCH ASSİSSTANT
38 participants (actual enrollment reported by the registry).
First Submitted
February 24, 2023
First Posted
March 23, 2023
Study Start
LIE program: LIE program was similar to the HIE program. Main differences from the HIE program was repetitions of exercises. All exercises were performed by the patients for 2 sets of 8 repetitions and CPM sessions lasted each exercises session. LIE program took thirty minutes while HIE program lasted sixty minutes. Exercise intensity was monitored using the rating of perceived exertion (RPE) scale, maintaining a range between 6 and 20 RPE (16). PRE\< 8 indicates low intensity, PRE\>14 indicates high intensity
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January 1, 2022
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)Last Updated
March 23, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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