The Effectiveness of Progressive Relaxation Exercises

NCT04038918 | Completed

• 1 other identifier: ME-PMR
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Outcomes; Muscle Strength

Keywords

Total knee arthroplasty; progressive muscle relaxation exercise; pain; functional outcomes; muscle strength

Outcome Measures

Primary Outcomes (6)

• The Numeric Pain Rating Scale

  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).

  Postoperative three months

• Iowa Level of Assistance Scale

  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

  Postoperative three months

• Hospital for Special Surgery Knee Score

  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.

  Postoperative three months

• 10 meter walk speed test

  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.

  Postoperative three months

• Timed Up and Go (TUG)

  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.

  Postoperative three months

• Muscle Strength

  Strength of knee muscles will be evaluated by hand-held dynamometer.

  Postoperative three months

Secondary Outcomes (4)

• Range of Motion

  Postoperative three months

• The Hospital Anxiety and Depression Scale (HADS)

  Postoperative three months

• Tampa Scale for Kinesiophobia (TSK)

  Postoperative three months

• 12-Item Short Form Survey

  Postoperative three months

Study Arms (2)

Progressive Muscle Relaxation Exercise Group

EXPERIMENTAL

Standard postoperative physiotherapy program plus progressive muscle relaxation (PMR) exercise will be applied.

Other: progressive muscle relaxation exercise; Other: standard postoperative physiotherapy program

Control Group

OTHER

Standard postoperative physiotherapy program will be applied.

Other: standard postoperative physiotherapy program

Interventions

progressive muscle relaxation exercise OTHER

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).

Progressive Muscle Relaxation Exercise Group

standard postoperative physiotherapy program OTHER

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; Progressive Muscle Relaxation Exercise Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (5)

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 BACKGROUND

• Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

  PMID: 15866968 BACKGROUND

• Baker PN, van der Meulen JH, Lewsey J, Gregg PJ; National Joint Registry for England and Wales. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg Br. 2007 Jul;89(7):893-900. doi: 10.1302/0301-620X.89B7.19091.

  PMID: 17673581 BACKGROUND

• Bernatzky G, Presch M, Anderson M, Panksepp J. Emotional foundations of music as a non-pharmacological pain management tool in modern medicine. Neurosci Biobehav Rev. 2011 Oct;35(9):1989-99. doi: 10.1016/j.neubiorev.2011.06.005. Epub 2011 Jun 16.

  PMID: 21704068 BACKGROUND

• Baird CL, Sands L. A pilot study of the effectiveness of guided imagery with progressive muscle relaxation to reduce chronic pain and mobility difficulties of osteoarthritis. Pain Manag Nurs. 2004 Sep;5(3):97-104. doi: 10.1016/j.pmn.2004.01.003.

  PMID: 15359221 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: July 31, 2019
• Study Start: February 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: October 1, 2020
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)