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NCT Number: NCT04981106

Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status

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.

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Key information

Conditions

Exercise Anxiety Disorders Behavior Kinesiophobia Mental Disorders Motor Activity Phobic Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Funda CETINKAYA

Aksaray, Select State, TR 68100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Unilateral Total Knee Arthroplasty

Exclusion criteria

Bilateral Total Knee Arthroplasty

Treatment and study plan

Elastic Band Exercise

Other

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.

Primary outcomes

  1. Tampa kinesiophobia index

    Time frame: First measurement two weeks after surgery (intervetion 58.2; control 54.1)

    Tampa is a 17-item scale

  2. WOMAC Osteoarthritis Index

    Time frame: First measurement two weeks after surgery (intervetion 89.3; control 88.1)

    WOMAC is a valid and reliable index that is widely used for assessing the patients with osteoarthritis.

  3. Beck's Depression Inventory

    Time frame: First measurement two weeks after surgery (intervetion 21.6; control 22.1)

    21 items in total.

Secondary outcomes

  1. Tampa kinesiophobia index

    Time frame: Second measurement six weeks after surgery (intervetion 36.9; control 42.9)

    Tampa is a 17-item scale

  2. WOMAC Osteoarthritis Index

    Time frame: Second measurement six weeks after surgery (intervetion 29; control 70.5)

    WOMAC is a valid and reliable index that is widely used for assessing the patients with

  3. Beck's Depression Inventory

    Time frame: Second measurement six weeks after surgery (intervetion 6.9; control 13.2)

    21 items in total.

Sponsors and collaborators

Lead sponsor

Aksaray University

Other

Registry information

Official study title

The Effects of Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status After Total Knee Arthroplasty

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2021
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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