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

NCT ID: NCT04981106

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Elastic Band Exercise

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 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.

Group Type EXPERIMENTAL

Elastic Band Exercise

Intervention Type 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.

Exercise

The patients in control group were recommended to maintain only an at-home exercise program incorporating knee flexion and extension exercises.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Unilateral Total Knee Arthroplasty

Exclusion Criteria

Bilateral Total Knee Arthroplasty
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aksaray University

OTHER

Sponsor Role lead

Responsible Party

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Funda Cetinkaya

Associate Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Funda CETINKAYA

Role: PRINCIPAL_INVESTIGATOR

Aksaray University

Ahmet KARAKOYUN, Dr

Role: PRINCIPAL_INVESTIGATOR

Aksaray University

Locations

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Funda CETINKAYA

Aksaray, Select State, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cetinkaya F, Karakoyun A. The effects of elastic band exercise on the pain, kinesiophobia, functional, and psychological status after total knee arthroplasty: a randomized controlled trial. Clin Rheumatol. 2022 Oct;41(10):3179-3188. doi: 10.1007/s10067-022-06266-0. Epub 2022 Jul 1.

Reference Type DERIVED
PMID: 35776283 (View on PubMed)

Other Identifiers

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2019/08-16

Identifier Type: -

Identifier Source: org_study_id

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