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The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia

Primary Purpose

Knee Osteoarthritis, Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High Intensity Exercises Program
Low Intensity Exercises Program
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total Knee Arthroplasty, Exercises intensity, pressure pain threshold, exercise-induced hypoalgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients had undergone primary unilateral total knee replacement surgery Patients hospitalized for at least seven days were enrolled in this study. Exclusion Criteria: Medically stable patients who used glucocorticoids or strong analgesic drugs Patients had post-traumatic OA, rheumatoid arthritis (RA), psoriatic arthritis, cognitive, hearing and visual problems Patients were diagnosed chronic pain condition were excluded from the study.

Sites / Locations

  • Merve Karapinar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HIE program

LIE Program

Arm Description

HIE program ; High Intensity Exercises Program. 3 sets of 15 repetition

Low Intensity Exercises program 2 sets of 8 repetition

Outcomes

Primary Outcome Measures

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).
Change of Pressure pain theshold
Pressure pain threshold (PPTs) were assessed using a handheld pressure algo-meter

Secondary Outcome Measures

Full Information

First Posted
February 24, 2023
Last Updated
March 10, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05781230
Brief Title
The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia
Official Title
The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia: Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

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 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.
Detailed Description
Background: 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. Methods : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Pain, Acute
Keywords
Total Knee Arthroplasty, Exercises intensity, pressure pain threshold, exercise-induced hypoalgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients were block-randomized based on intensity of exercises. The randomization sequence was produced by an external investigator using a computer-generated randomization sequence (Microsoft Excel, Microsoft, Redmond, WA, USA) to generate either a 0 or 1, corresponding with high intensity exercises or low intensity exercises, respectively
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIE program
Arm Type
Experimental
Arm Description
HIE program ; High Intensity Exercises Program. 3 sets of 15 repetition
Arm Title
LIE Program
Arm Type
Experimental
Arm Description
Low Intensity Exercises program 2 sets of 8 repetition
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Exercises Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Intensity Exercises Program
Intervention Description
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
Primary Outcome Measure Information:
Title
change of pain severity
Description
. The pain severity evaluated using a visual analogue scale (VAS; scored from 0, no pain, to 100, the worst pain ever).
Time Frame
admission to hospital service to discharge from hospital service, an average 5 days
Title
Change of Pressure pain theshold
Description
Pressure pain threshold (PPTs) were assessed using a handheld pressure algo-meter
Time Frame
admission to hospital service to discharge from hospital service, an average 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients had undergone primary unilateral total knee replacement surgery Patients hospitalized for at least seven days were enrolled in this study. Exclusion Criteria: Medically stable patients who used glucocorticoids or strong analgesic drugs Patients had post-traumatic OA, rheumatoid arthritis (RA), psoriatic arthritis, cognitive, hearing and visual problems Patients were diagnosed chronic pain condition were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MERVE KARAPINAR, PT
Organizational Affiliation
RESEARCH ASSİSSTANT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merve Karapinar
City
Isparta
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia

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