Clinical trial NCT03421938: Effect of Downhill-uphill Walking Exercises on Functional Level and Muscle Strength in Patients With Knee Arthroplasty.
Official title: Investigation of the Effect of Downhill-uphill Walking Exercises on Functional Level and Muscle Strength in Patients With Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Arthroplasty
Keywords: total knee arthroplasty
walking exercises
uphill-downhill walking exercises
functional level
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Iowa Level of Assistance Scale
timeFrame: Change from Baseline Patient's Functional Level at 4 weeks
measure: Change of Hospital For Special Surgery Knee Score
timeFrame: Change from Baseline Patient's Functional Level at 4 weeks
measure: Change of 10 meter walk speed test
timeFrame: Change from Baseline Patient's Functional Level at 4 weeks
measure: Change of Timed Up and Go (TUG)
timeFrame: Change from Baseline Patient's Functional Level at 4 weeks
Secondary outcomes:
measure: SF-12
timeFrame: Change from Baseline SF-12 score Level at 4 weeks
measure: Numeric Pain Scale
timeFrame: Change from Baseline Patient's Pain Level at 4 weeks
measure: Range of Motion
timeFrame: Change from Baseline Patient's Range of Motion 4th week
measure: Muscle Strength
timeFrame: Change from Baseline Patient's Muscles Strengths at 4 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Abdurrahman Nalbant, PT,MSc
role: PRINCIPAL_INVESTIGATOR
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