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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04981106
Other study ID # 2019/08-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date April 30, 2020

Study information

Verified date July 2023
Source Aksaray University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aiming to determine the effects of elastic band exercise on kinesiophobia, functional capacity, and depression after the total knee arthroplasty, the present study was designed and carried out as a randomized controlled trial study. The study was carried out between October 2019 and April 2020 in the Physical Therapy and Rehabilitation Department of a training and research hospital.This study, the effects of elastic band exercise program on the pain, kinesiophobia, quality of life, depression, and functional capacity of TKA patients were examined. Elastic band exercise program significantly decreased the pain level, exercise fear, and depression level of patients and positively contributed to the quality of life and functional capacity.


Description:

All the participants were subjected to walking training and a standard postoperative care and exercise protocol until discharged from the hospital. During discharging, all the participants in both groups were provided with explanation and illustration about how to perform the exercises. In order to prevent any problem, the participants in both groups were recommended to start the at-home rehabilitation programs, which incorporate knee movement exercises, to be ready 2 weeks (14 days) after the surgery and they were asked to continue their current exercise programs thus far. The patients in control group were recommended to maintain only an at-home exercise program incorporating knee flexion and extension exercises. The patients in intervention group were recommended to do, in addition to the at-home exercise program given to the patients in control group, elastic band exercises and researchers showed them how to use the elastic bands by making use of instructions.The participants were asked to do exercise 4 times a day with a minimum of 2 hours interval between the sessions. The participants were instructed to avoid elastic band exercise 1 hour before or after the meals in order to prevent a physical impairment and to adopt a moderately progressive approach in order to prevent lower extremity pain after exercise and to increase the sense of success and confidence.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: Unilateral Total Knee Arthroplasty Exclusion Criteria: Bilateral Total Knee Arthroplasty

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Elastic Band Exercise
The participants were asked to do exercise 4 times a day with a minimum of 2 hours interval between the sessions. The participants were instructed to avoid elastic band exercise 1 hour before or after the meals in order to prevent a physical impairment and to adopt a moderately progressive approach in order to prevent lower extremity pain after exercise and to increase the sense of success and confidence. Through phone calls, researchers asked the participants in intervention group if they do the elastic band exercises at home and if they had any difficulty while doing these exercises, as well as the reasons if they haven't done the exercises. When the participants in control and intervention groups returned to hospital after 4 weeks, the knee joint movement, lower extremity strength, knee joint pain, quality of life, kinesiophobia, and depression levels and physical functions of these groups were compared.

Locations

Country Name City State
Turkey Funda CETINKAYA Aksaray Select State

Sponsors (1)

Lead Sponsor Collaborator
Aksaray University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tampa kinesiophobia index Tampa is a 17-item scale First measurement two weeks after surgery (intervetion 58.2; control 54.1)
Primary WOMAC Osteoarthritis Index WOMAC is a valid and reliable index that is widely used for assessing the patients with osteoarthritis. First measurement two weeks after surgery (intervetion 89.3; control 88.1)
Primary Beck's Depression Inventory 21 items in total. First measurement two weeks after surgery (intervetion 21.6; control 22.1)
Secondary Tampa kinesiophobia index Tampa is a 17-item scale Second measurement six weeks after surgery (intervetion 36.9; control 42.9)
Secondary WOMAC Osteoarthritis Index WOMAC is a valid and reliable index that is widely used for assessing the patients with Second measurement six weeks after surgery (intervetion 29; control 70.5)
Secondary Beck's Depression Inventory 21 items in total. Second measurement six weeks after surgery (intervetion 6.9; control 13.2)
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