Relaxation Treatment in Total Knee Arthroplasty

NCT04845204 | Completed

• 1 other identifier: GO 15/77-22
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (TKA) are generally good. However, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their TKA. Psychological symptoms were found to be associated with these suboptimal results. The aim of the present study is to determine weather relaxation techniques had beneficial effects on pain, sleeping quality, functional status and physiological symptoms in TKA patients during their hospital stay.

Conditions

Relaxation; Joint; Total Knee Arthroplasty; Exercise

Outcome Measures

Primary Outcomes (1)

• Pain Level Change

  Visual analog scale

  Mean change from Postoperative day 1 to day 4 recorded

Secondary Outcomes (4)

• Sleep Quality Change

  Mean change from Postoperative day 1 to day 4 recorded

• Functional Outcomes Change

  Mean change from Postoperative day4 to 6 weeks following surgery recorded

• Functional Outcomes Change

  Mean change from Postoperative day4 to 6 weeks following surgery recorded

• Knee Range of Motion Change

  Mean change from Postoperative day4 to 6 weeks following surgery recorded

Study Arms (2)

Relaxation Treatment

ACTIVE COMPARATOR

Relaxation treatment (RT) is applied additional to standard physiotherapy treatment. RT includes 8 sessions (2 times a day, for four days after surgery) of relaxation exercises.

Other: Standard Exercises

Standard Exercises

ACTIVE COMPARATOR

Standard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures.

Other: Relaxation Treatment

Interventions

Relaxation Treatment OTHER

Relaxation Group recieve progressive muscle relaxation exercises additional to the standard exercises. The relaxation exercises are applied two times a day till the discharge day starting on the postoperative day one. Progressive muscle relaxation included the relaxing of different muscle groups along with deep breathing. The maximal contraction period consist of the contraction of muscle groups around ankle, calf, knee, hip, lumbar, thoracic and cervical regions, shoulder, arm, forearm for 5 s and continued with a relaxation period for 30 s while focusing on breathing. These two periods ware repeated for each muscle groups and lasted approximately 30 min

Also known as: Standard Exercises

Standard Exercises

Standard Exercises OTHER

The physiotherapy protocol is applied under the supervision of the same physiotherapist within a progressive manner immediately after surgery. Continued passive range of motion is applied twice a day starting with 45º of knee flexion range of motion and increased gradually as tolerated. All patients performed same isometric, isotonic and active exercises. Patients were instructed to bear weight as tolerated on the postoperative day 1

Also known as: Relaxation Treatment

Relaxation Treatment

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee osteoarthritis, Female Patients who are scheduled for unilateral Total Knee Arthroplasty surgery, were included in the study.

You may not qualify if:

• having a previous knee or hip surgery or fracture, diagnosis of rheumatoid arthritis, severe obesity (BMI\>40 kg/m2), sensory and motor disorders in the operated limb, inability to understand pain assessment.

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (2)

• Koken M, Guclu B. The Effects of Total Knee Arthroplasty on Sleep Quality. Malays Orthop J. 2019 Jul;13(2):11-14. doi: 10.5704/MOJ.1907.002.

  PMID: 31467645 BACKGROUND

• Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.

  PMID: 27295978 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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: Associate Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 14, 2021
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share