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

August 17, 2021 updated by: Abdurrahman Nalbant, Dokuz Eylul University

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

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 %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope. Assessments will be made before and after treatment.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 %10 slope; group 2 uphill walking exercises on the treadmill with %10 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35340
        • Dokuz Eylül University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (Downhill Exercise Group)
This group will have downhill walking exercises with %10 slope.
Other: Walking Exercise
Group 1 will have downhill walking exercises with %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope..
Experimental: Group 2 ( Uphill Exercise Group)
This group will have uphill walking exercises on the treadmill with %10 slope.
Other: Walking Exercise
Group 1 will have downhill walking exercises with %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from Baseline Patient's Functional Level at 4 weeks
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 from Baseline Patient's Functional Level at 4 weeks
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 from Baseline Patient's Functional Level at 4 weeks
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.
Change from Baseline Patient's Functional Level at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline SF-12 score Level at 4 weeks
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.
Change from Baseline Patient's Pain Level at 4 weeks
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.
Change from Baseline Patient's Range of Motion 4th week
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.
Change from Baseline Patient's Muscles Strengths at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Principal Investigator: Abdurrahman Nalbant, PT,MSc, Dokuz Eylül University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Anticipated)

March 20, 2018

Study Completion (Anticipated)

March 20, 2018

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3243-GOA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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