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The Effectiveness of Progressive Relaxation Exercises

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038918
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Musa Eymir, Dokuz Eylul University

Brief Summary:
The purpose of this study is to investigate the effectiveness of progressive muscle relaxation (PMR) exercise on pain, functional outcomes and muscle strength in patients with TKA. Seventy patients with TKA are going to randomly assigned to intervention group and control group.

Condition or disease Intervention/treatment Phase
Functional Outcomes Muscle Strength Other: progressive muscle relaxation exercise Other: standard postoperative physiotherapy program Not Applicable

Detailed Description:

Total knee arthroplasty (TKA) is applied in end-stage osteoarthritis to reduce pain, improve functional ability, and provide greater health related quality of life. However, evidence showed that presence of severe pain, impaired functional outcomes and reduced muscle strength continue up to 6 to 12 month after surgery. Relaxation techniques such as progressive muscle relaxation exercise and rhythmic breathing have long been used in treating postoperative pain and for various health-related purposes. Although the number of studies that include relaxation techniques in treating postoperative pain is increasing, there isn't any study that investigate the effectiveness of progressive muscle relaxation exercise on pain, functional outcomes and muscle strength in patients with TKA.

The aim is to investigate the effectiveness of progressive muscle relaxation (PMR) exercise on pain, functional outcomes and muscle strength in patients with TKA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Effectiveness of Relaxation Exercises on Pain, Functional Outcomes and Muscle Strength in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progressive Muscle Relaxation Exercise Group
Standard postoperative physiotherapy program plus progressive muscle relaxation (PMR) exercise will be applied.
Other: progressive muscle relaxation exercise
In addition to standard postoperative rehabilitation, intervention group will receive PMR exercises focusing on reduce overall body tension, anxiety. The intervention group will perform the PMR exercise in accompanying with a qualified physiotherapist for postoperative 3 days (2 times/day; along 30 minutes for one session).

Other: standard postoperative physiotherapy program
After surgery, patients will receive standard postoperative rehabilitation program including active-assistive and active range of motion exercises, isometric and isotonic strengthening exercises, gait training and transfer training.

Control Group
Standard postoperative physiotherapy program will be applied.
Other: standard postoperative physiotherapy program
After surgery, patients will receive standard postoperative rehabilitation program including active-assistive and active range of motion exercises, isometric and isotonic strengthening exercises, gait training and transfer training.




Primary Outcome Measures :
  1. The Numeric Pain Rating Scale [ Time Frame: Postoperative three months ]
    The Numeric Rating Scale (NPRS), reliable and valid instrument, is commonly used to determine for pain intensity in rehabilitation. The activity and resting pain level in the knee joints will be evaluated by NPRS from 0 to 10 (0 refers to no pain, 10 refers to worst pain).

  2. Iowa Level of Assistance Scale [ Time Frame: Postoperative three months ]

    This test assesses the patient's ability to perform four functional activities, namely, supine to sitting on the edge of the bed, sitting on the edge of the bed to standing, walking 4.57 meters. The scoring of these activities is done as independent 6 points, observational aid 5 points, minimum help 4 points, medium help 3 points, maximum help 2 points, fail 1 point and untested 0 points. Higher values represent a better outcome.

    Speed scoring is done by evaluating the walking speed at a distance of 13.4 meters (44 steps). 20 seconds (sec) and below are recorded as 0, 21-30 sec 1, 31-40 sec 2, 41-50 3, 51-60 sec 4, 61-70 sec 5 and 70 sec. Higher values represent a worse outcome


  3. Hospital for Special Surgery Knee Score [ Time Frame: Postoperative three months ]
    Hospital for Special Surgery knee score. A scoring system evaluation of pain, mobility, range of motion and deforming of the knee giving 0-100 points.

  4. 10 meter walk speed test [ Time Frame: Postoperative three months ]
    10MWT testing distance require 5-m acceleration and 5-m deceleration space, with the inner 10-m zone being the distance over which gait is timed. Before the test, patients should be asked to walk as fast as possible and allowed to use assistive devices (cane, walker) if needed. Patients start to walk and accelerate in the 20-m. The stopwatch is started as soon as the patient's leg pass over the starting line and stopped the patient's leg pass over the 10-m sign.

  5. Timed Up and Go (TUG) [ Time Frame: Postoperative three months ]
    To determine fall risk and measure the progress of balance, sit to stand, and walking. The patient starts in a seated position. The patient stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device.

  6. Muscle Strength [ Time Frame: Postoperative three months ]
    Strength of knee muscles will be evaluated by hand-held dynamometer.


Secondary Outcome Measures :
  1. Range of Motion [ Time Frame: Postoperative three months ]
    Each patient's active (unassisted) range of knee extension and flexion will be measured, using a goniometer with the patient in the supine position.

  2. The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Postoperative three months ]
    The HADS aims to measure symptoms of anxiety and depression and consists of 14 items, seven items for the anxiety subscale (HADS Anxiety) and seven for the depression subscale (HADS Depression). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. After adjusting for six items that are reversed scored, all responses are summed to obtain the two subscales. The scoring of HADS is done as normal 0-7 point, borderline case 8-10 points, abnormal case 11-21. Higher values represent a worse outcome.

  3. Tampa Scale for Kinesiophobia (TSK) [ Time Frame: Postoperative three months ]
    The term kinesiophobia refers to a fear of pain with movement - i.e., movements which a patient is hesitant to perform due to fear that the movement will elicit pain. The TSK has been used to assess kinesiophobia in patients with a wide variety of conditions, such as knee disorders. The TSK consists of 17 questions. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.

  4. 12-Item Short Form Survey [ Time Frame: Postoperative three months ]
    SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view. The SF-12 is a practical, reliable and valid measure of physical and mental health and is particularly useful in large population health surveys or for applications that combine a generic and disease-specific health survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 30 years older above
  • Preoperative diagnosis have to be knee osteoarthritis
  • Have a primary total knee arthroplasty
  • Able to understand Turkish instructions
  • Willing and able to attend study

Exclusion Criteria:

  • Revision total knee arthroplasty
  • Unable to understand verbal and written instructions
  • Having previously orthopaedic or neurological disorder that causes gait disturbance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038918


Contacts
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Contact: Musa Eymir, MSc, PT +902324124939 fztmusaeymir@hotmail.com
Contact: Bayram Ünver, Prof, PT. +902324124928 bayram.unver@deu.edu.tr

Locations
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Turkey
Dokuz Eylul University Recruiting
İzmir, Turkey, 35340
Contact: Bayram Ünver, PhD, PT    +90 2324124928    bayram.unver@deu.edu.tr   
Contact: Vasfi Karatosun, PhD, MD    +90 2324123360    vasfi.karatosun@gmail.com   
Sponsors and Collaborators
Dokuz Eylul University
Publications:
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Responsible Party: Musa Eymir, Research Assistant, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT04038918    
Other Study ID Numbers: ME-PMR
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Musa Eymir, Dokuz Eylul University:
Total knee arthroplasty
progressive muscle relaxation exercise
pain
functional outcomes
muscle strength