Clinical trial NCT04981106: Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status
Official title: The Effects of Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: elastic band exercise
kinesiophobia
functional, psychological status
Lead sponsor: Aksaray University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Unilateral Total Knee Arthroplasty

Exclusion Criteria:

Bilateral Total Knee Arthroplasty

Primary outcomes:
measure: Tampa kinesiophobia index
timeFrame: First measurement two weeks after surgery (intervetion 58.2; control 54.1)
measure: WOMAC Osteoarthritis Index
timeFrame: First measurement two weeks after surgery (intervetion 89.3; control 88.1)
measure: Beck's Depression Inventory
timeFrame: First measurement two weeks after surgery (intervetion 21.6; control 22.1)
Secondary outcomes:
measure: Tampa kinesiophobia index
timeFrame: Second measurement six weeks after surgery (intervetion 36.9; control 42.9)
measure: WOMAC Osteoarthritis Index
timeFrame: Second measurement six weeks after surgery (intervetion 29; control 70.5)
measure: Beck's Depression Inventory
timeFrame: Second measurement six weeks after surgery (intervetion 6.9; control 13.2)
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Funda CETINKAYA
state: Select State
Study officials:
affiliation: Aksaray University
name: Funda CETINKAYA
role: PRINCIPAL_INVESTIGATOR
affiliation: Aksaray University
name: Ahmet KARAKOYUN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.