NCT03421938

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

January 17, 2018

Last Update Submit

August 17, 2021

Conditions

Keywords

total knee arthroplastywalking exercisesuphill-downhill walking exercisesfunctional level

Outcome Measures

Primary Outcomes (4)

  • Change of 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 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

    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

    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)

    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 Outcomes (4)

  • SF-12

    Change from Baseline SF-12 score Level at 4 weeks

  • Numeric Pain Scale

    Change from Baseline Patient's Pain Level at 4 weeks

  • Range of Motion

    Change from Baseline Patient's Range of Motion 4th week

  • Muscle Strength

    Change from Baseline Patient's Muscles Strengths at 4 weeks

Study Arms (2)

Group 1 (Downhill Exercise Group)

EXPERIMENTAL

This group will have downhill walking exercises with %10 slope.

Other: Walking Exercise

Group 2 ( Uphill Exercise Group)

EXPERIMENTAL

This group will have uphill walking exercises on the treadmill with %10 slope.

Other: Walking Exercise

Interventions

Group 1 will have downhill walking exercises with %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope..

Group 1 (Downhill Exercise Group)Group 2 ( Uphill Exercise Group)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (16)

  • Shields RK, Enloe LJ, Leo KC. Health related quality of life in patients with total hip or knee replacement. Arch Phys Med Rehabil. 1999 May;80(5):572-9. doi: 10.1016/s0003-9993(99)90202-2.

    PMID: 10326924BACKGROUND
  • Moffet H, Collet JP, Shapiro SH, Paradis G, Marquis F, Roy L. Effectiveness of intensive rehabilitation on functional ability and quality of life after first total knee arthroplasty: A single-blind randomized controlled trial. Arch Phys Med Rehabil. 2004 Apr;85(4):546-56. doi: 10.1016/j.apmr.2003.08.080.

    PMID: 15083429BACKGROUND
  • Noble PC, Gordon MJ, Weiss JM, Reddix RN, Conditt MA, Mathis KB. Does total knee replacement restore normal knee function? Clin Orthop Relat Res. 2005 Feb;(431):157-65. doi: 10.1097/01.blo.0000150130.03519.fb.

    PMID: 15685070BACKGROUND
  • Wylde V, Dieppe P, Hewlett S, Learmonth ID. Total knee replacement: is it really an effective procedure for all? Knee. 2007 Dec;14(6):417-23. doi: 10.1016/j.knee.2007.06.001. Epub 2007 Jun 26.

    PMID: 17596949BACKGROUND
  • Petterson SC, Mizner RL, Stevens JE, Raisis L, Bodenstab A, Newcomb W, Snyder-Mackler L. Improved function from progressive strengthening interventions after total knee arthroplasty: a randomized clinical trial with an imbedded prospective cohort. Arthritis Rheum. 2009 Feb 15;61(2):174-83. doi: 10.1002/art.24167.

    PMID: 19177542BACKGROUND
  • Yoshida Y, Mizner RL, Ramsey DK, Snyder-Mackler L. Examining outcomes from total knee arthroplasty and the relationship between quadriceps strength and knee function over time. Clin Biomech (Bristol). 2008 Mar;23(3):320-8. doi: 10.1016/j.clinbiomech.2007.10.008. Epub 2007 Dec 3.

    PMID: 18060669BACKGROUND
  • Rossi MD, Hasson S. Lower-limb force production in individuals after unilateral total knee arthroplasty. Arch Phys Med Rehabil. 2004 Aug;85(8):1279-84. doi: 10.1016/j.apmr.2003.11.034.

    PMID: 15295753BACKGROUND
  • Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. doi: 10.2519/jospt.2005.35.7.424.

    PMID: 16108583BACKGROUND
  • Meier WA, Marcus RL, Dibble LE, Foreman KB, Peters CL, Mizner RL, LaStayo PC. The long-term contribution of muscle activation and muscle size to quadriceps weakness following total knee arthroplasty. J Geriatr Phys Ther. 2009;32(2):79-82.

    PMID: 20039587BACKGROUND
  • Berth A, Urbach D, Awiszus F. Improvement of voluntary quadriceps muscle activation after total knee arthroplasty. Arch Phys Med Rehabil. 2002 Oct;83(10):1432-6. doi: 10.1053/apmr.2002.34829.

    PMID: 12370881BACKGROUND
  • Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.

    PMID: 16078331BACKGROUND
  • LaStayo P, Marcus R, Dibble L, Frajacomo F, Lindstedt S. Eccentric exercise in rehabilitation: safety, feasibility, and application. J Appl Physiol (1985). 2014 Jun 1;116(11):1426-34. doi: 10.1152/japplphysiol.00008.2013. Epub 2013 Jul 3.

    PMID: 23823152BACKGROUND
  • Rodio A, Fattorini L. Downhill walking to improve lower limb strength in healthy young adults. Eur J Sport Sci. 2014;14(8):806-12. doi: 10.1080/17461391.2014.908958. Epub 2014 Apr 23.

    PMID: 24754630BACKGROUND
  • Samaei A, Bakhtiary AH, Hajihasani A, Fatemi E, Motaharinezhad F. Uphill and Downhill Walking in Multiple Sclerosis: A Randomized Controlled Trial. Int J MS Care. 2016 Jan-Feb;18(1):34-41. doi: 10.7224/1537-2073.2014-072.

    PMID: 26917996BACKGROUND
  • Langhammer B, Stanghelle JK. Exercise on a treadmill or walking outdoors? A randomized controlled trial comparing effectiveness of two walking exercise programmes late after stroke. Clin Rehabil. 2010 Jan;24(1):46-54. doi: 10.1177/0269215509343328. Epub 2009 Dec 21.

    PMID: 20026572BACKGROUND
  • Wiik AV, Aqil A, Tankard S, Amis AA, Cobb JP. Downhill walking gait pattern discriminates between types of knee arthroplasty: improved physiological knee functionality in UKA versus TKA. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1748-55. doi: 10.1007/s00167-014-3240-x. Epub 2014 Aug 27.

    PMID: 25160471BACKGROUND

Study Officials

  • Abdurrahman Nalbant, PT,MSc

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 5, 2018

Study Start

October 11, 2017

Primary Completion

March 20, 2018

Study Completion

March 20, 2018

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations