ExerciseNCT04981106
Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status
A study testing Elastic Band Exercise in people with Exercise, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Exercise
- What is being tested?
- Elastic Band Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral Total Knee Arthroplasty
Who cannot join
- Bilateral Total Knee Arthroplasty
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Funda CETINKAYA
Aksaray, Select State, TR 68100
About this study
Official title: The Effects of Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status After Total Knee Arthroplasty
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.
Read the 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.
- Conditions
- Exercise
- Being tested
- Elastic Band Exercise
- Keywords
- elastic band exercise, kinesiophobia, functional, psychological status
- Medical subject headings
- Motor Activity, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Band ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa kinesiophobia index
Tampa is a 17-item scale
Measured: 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.
Measured: First measurement two weeks after surgery (intervetion 89.3; control 88.1)
Beck's Depression Inventory
21 items in total.
Measured: First measurement two weeks after surgery (intervetion 21.6; control 22.1)
Secondary outcomes (3)
Tampa kinesiophobia index
Tampa is a 17-item scale
Measured: Second measurement six weeks after surgery (intervetion 36.9; control 42.9)
WOMAC Osteoarthritis Index
WOMAC is a valid and reliable index that is widely used for assessing the patients with
Measured: Second measurement six weeks after surgery (intervetion 29; control 70.5)
Beck's Depression Inventory
21 items in total.
Measured: Second measurement six weeks after surgery (intervetion 6.9; control 13.2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Oct 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Cetinkaya, Aksaray University
- Investigators
- Funda CETINKAYA, Principal investigator, Aksaray UniversityAhmet KARAKOYUN, Dr, Principal investigator, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981106
- Sponsor's protocol ID
- 2019/08-16
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2021
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35776283
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04981106
- Acronym / sponsor ID
- 2019/08-16
- Conditions
- Exercise
- Keywords
- elastic band exercise, kinesiophobia, functional, psychological status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Elastic Band Exercise | Experimental | Other: Elastic Band ExerciseAll 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. |
| Exercise | No intervention | –The patients in control group were recommended to maintain only an at-home exercise program incorporating knee flexion and extension exercises. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral Total Knee Arthroplasty
Key exclusion criteria (1 listed)
- Bilateral Total Knee Arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic Band ExerciseThe 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. | Other | Elastic Band Exercise |
Primary outcome
Tampa kinesiophobia index
Time frame: First measurement two weeks after surgery (intervetion 58.2; control 54.1)
Tampa is a 17-item scale
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.
Beck's Depression Inventory
Time frame: First measurement two weeks after surgery (intervetion 21.6; control 22.1)
21 items in total.
3 secondary outcomes
Tampa kinesiophobia index
Time frame: Second measurement six weeks after surgery (intervetion 36.9; control 42.9)
WOMAC Osteoarthritis Index
Time frame: Second measurement six weeks after surgery (intervetion 29; control 70.5)
Beck's Depression Inventory
Time frame: Second measurement six weeks after surgery (intervetion 6.9; control 13.2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Derived from this study: PubMed 35776283Cetinkaya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Funda CETINKAYA principal investigator
Aksaray University
Ahmet KARAKOYUN, Dr principal investigator
Aksaray University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Band Exercise in people with Exercise, run by Aksaray University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa kinesiophobia index (time frame: First measurement two weeks after surgery (intervetion 58.2; control 54.1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.