NCT04981106

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

July 14, 2021

Last Update Submit

July 6, 2023

Conditions

Keywords

elastic band exercisekinesiophobiafunctional, psychological status

Outcome Measures

Primary Outcomes (3)

  • Tampa kinesiophobia index

    Tampa is a 17-item scale

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

  • 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)

  • Beck's Depression Inventory

    21 items in total.

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

Secondary Outcomes (3)

  • Tampa kinesiophobia index

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

  • WOMAC Osteoarthritis Index

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

  • Beck's Depression Inventory

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

Study Arms (2)

Elastic Band Exercise

EXPERIMENTAL

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.

Other: Elastic Band Exercise

Exercise

NO INTERVENTION

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

Interventions

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.

Elastic Band Exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral Total Knee Arthroplasty

You may not qualify if:

  • Bilateral Total Knee Arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Funda CETINKAYA

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

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor ActivityKinesiophobia

Condition Hierarchy (Ancestors)

BehaviorPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Funda CETINKAYA

    Aksaray University

    PRINCIPAL INVESTIGATOR
  • Ahmet KARAKOYUN, Dr

    Aksaray University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 28, 2021

Study Start

October 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations