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

Sponsor
Aksaray University (Other)
Overall Status
Completed
CT.gov ID
NCT04981106
Collaborator
(none)
60
1
2
7
8.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Elastic Band Exercise
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlledRandomized controlled
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status After Total Knee Arthroplasty
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: Exercise

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

Outcome Measures

Primary Outcome Measures

  1. Tampa kinesiophobia index [First measurement two weeks after surgery (intervetion 58.2; control 54.1)]

    Tampa is a 17-item scale

  2. WOMAC Osteoarthritis Index [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 [First measurement two weeks after surgery (intervetion 21.6; control 22.1)]

    21 items in total.

Secondary Outcome Measures

  1. Tampa kinesiophobia index [Second measurement six weeks after surgery (intervetion 36.9; control 42.9)]

    Tampa is a 17-item scale

  2. WOMAC Osteoarthritis Index [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 [Second measurement six weeks after surgery (intervetion 6.9; control 13.2)]

    21 items in total.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Unilateral Total Knee Arthroplasty

Exclusion Criteria:

Bilateral Total Knee Arthroplasty

Contacts and Locations

Locations

Site City State Country Postal Code
1 Funda CETINKAYA Aksaray Select State Turkey TR 68100

Sponsors and Collaborators

  • Aksaray University

Investigators

  • Principal Investigator: Funda CETINKAYA, Aksaray University
  • Principal Investigator: Ahmet KARAKOYUN, Dr, Aksaray University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Funda Cetinkaya, Associate Professor Doctor, Aksaray University
ClinicalTrials.gov Identifier:
NCT04981106
Other Study ID Numbers:
  • 2019/08-16
First Posted:
Jul 28, 2021
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Funda Cetinkaya, Associate Professor Doctor, Aksaray University

Study Results

No Results Posted as of Aug 13, 2021