Effect of Downhill-uphill Walking Exercises on Functional Level and Muscle Strength in Patients With Knee Arthroplasty.

Overview

This study is planned for investigating effect of downhill-uphill walking exercises on functional level and muscle strength in patients with knee arthroplasty. Patients who have had primary knee arthroplasty and has gone 3 months after surgery will be included in this study. The patients will be divided into two groups by randomization. Totally, 22 patients will be included in this study. Every patients will have same standart post-operative rehabilitation programme. In addition,group 1 will have downhill walking exercises with slope; group 2 uphill walking exercises on the treadmill with slope. Assessments will be made before and after treatment.

Full Title of Study: “Investigation of the Effect of Downhill-uphill Walking Exercises on Functional Level and Muscle Strength in Patients With Knee Arthroplasty.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 20, 2018

Detailed Description

This study is planned for investigating effect of downhill-uphill walking exercises on functional level and muscle strength in patients with knee arthroplasty. Patients who have had primary knee arthroplasty and has gone 3 months after surgery will be included in this study. The patients will be divided into two groups by randomization. Totally, 22 patients will be included in this study. Every patients will have same standart post-operative rehabilitation programme. Assessments will be made before and after treatment. Rehabilitation programme after knee arthroplasty has included muscle strength and endurance, balance and proprioceptive sensation, increasing functional level and providing independence in daily life activities.For this purpose, a standard physiotherapy program will be implemented in accordance with the goals and objectives stated for all patients. In addition,group 1 will have downhill walking exercises with slope; group 2 uphill walking exercises on the treadmill with slope. It takes 30 minutes for one session.

Exercise intensity was measured before treatment; will be determined using the Karvonen formula depending on the heart rate. Walking intensity during exercise; 55% of the maximum heart rate will be determined at the beginning of the treatment and 85% towards the end of the treatment. Walking exercise on the treadmill will be performed in conjunction with a qualified physiotherapist in this area for 4 weeks(3 session in 1 week).

Within the scope of the assessments, patients' pain levels will be determined using the Numeric Pain Scale (NAS). For the knee joint, the normal range of motion will be determined by universal goniometer. For the determination of functional level, Iowa functional activity scale, Iowa ambulatory speed scale and Hospital For Special Surgery (HSS) knee scoring, 10-meter walking speed, Timed Up and Go (TUG) test, SF-12(12-Item Short Form Survey) quality of life scale will be used. Hand dynamometer will be used to evaluate muscle strength.These assessments will be made before and after treatment.

Interventions

  • Other: Walking Exercise
    • Group 1 will have downhill walking exercises with slope; group 2 uphill walking exercises on the treadmill with slope..

Arms, Groups and Cohorts

  • Experimental: Group 1 (Downhill Exercise Group)
    • This group will have downhill walking exercises with slope.
  • Experimental: Group 2 ( Uphill Exercise Group)
    • This group will have uphill walking exercises on the treadmill with slope.

Clinical Trial Outcome Measures

Primary Measures

  • Change of Iowa Level of Assistance Scale
    • Time Frame: Change from Baseline Patient’s Functional Level at 4 weeks
    • 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 metres. 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 untest 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
  • Change of Hospital For Special Surgery Knee Score
    • Time Frame: Change from Baseline Patient’s Functional Level at 4 weeks
    • 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
  • Change of 10 meter walk speed test
    • Time Frame: Change from Baseline Patient’s Functional Level at 4 weeks
    • Individual walks without assistance 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration, start timing when the toes of the leading foot crosses the 2-meter mark, stop timing when the toes of the leading foot crosses the 8-meter mark,assistive devices can be used but should be kept consistent and documented from test to test, if physical assistance is required to walk, this should not be performed can be performed at preferred walking speed or fastest speed possible documentation should include the speed tested (preferred vs. fast) collect three trials and calculate the average of the three trials
  • Change of Timed Up and Go (TUG)
    • Time Frame: Change from Baseline Patient’s Functional Level at 4 weeks
    • 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.

Secondary Measures

  • SF-12
    • Time Frame: Change from Baseline SF-12 score Level at 4 weeks
    • 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.
  • Numeric Pain Scale
    • Time Frame: Change from Baseline Patient’s Pain Level at 4 weeks
    • Severity of pain was rated by each patient marking their current level of pain on a 10cm visual analogue scale (VAS), where 0 represented no pain and 10 was the worst pain imaginable.Higher values represent a worse outcome.
  • Range of Motion
    • Time Frame: Change from Baseline Patient’s Range of Motion 4th week
    • Each patient’s active (unassisted) range of knee extension and flexion will be measured, using a goniometer with the patient in the supine position.
  • Muscle Strength
    • Time Frame: Change from Baseline Patient’s Muscles Strengths at 4 weeks
    • Strength of knee muscles will be evaluated by hand-held dynamometer.

Participating in This Clinical Trial

Inclusion Criteria

  • Preoperative diagnosis have to be knee osteoarthritis.
  • Patients with primary knee arthroplasty after 3 months surgery.

Exclusion Criteria

  • BMI >40 kg/m2
  • Having orthopedic or neurologic disorders which cause walking disorders.
  • Revision total knee arthroplasty

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dokuz Eylul University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Abdurrahman Nalbant, Principal Investigator – Dokuz Eylul University
  • Overall Official(s)
    • Abdurrahman Nalbant, PT,MSc, Principal Investigator, Dokuz Eylul University

References

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