Relaxation; JointNCT04845204
Relaxation Treatment in Total Knee Arthroplasty
A study testing Relaxation Treatment and Standard Exercises in people with Relaxation; Joint and Total Knee Arthroplasty, run by Hacettepe University.
Trial summary
Surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (TKA) are generally good. However, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their TKA. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Relaxation; Joint, Total Knee Arthroplasty, Exercise
- What is being tested?
- Relaxation Treatment and Standard Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2017
- 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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary knee osteoarthritis, Female Patients who are scheduled for unilateral Total Knee Arthroplasty surgery, were included in the study.
Who cannot join
- having a previous knee or hip surgery or fracture, diagnosis of rheumatoid arthritis, severe obesity (BMI>40 kg/m2), sensory and motor disorders in the operated limb, inability to understand pain assessment.
About this study
Official title: Effects of Progressive Muscle Relaxation Techniques on Pain, Sleeping Quality and Functional Levels After Total Knee Arthroplasty
Surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (TKA) are generally good. However, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their TKA. Psychological symptoms were found to be associated with these suboptimal results. The aim of the present study is to determine weather relaxation techniques had beneficial effects on pain, sleeping quality, functional status and physiological symptoms in TKA patients during their hospital stay.
- Conditions
- Relaxation; Joint, Total Knee Arthroplasty, Exercise
- Being tested
- Relaxation Treatment, Standard Exercises
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation TreatmentOther
Also called Standard Exercises
Relaxation Group recieve progressive muscle relaxation exercises additional to the standard exercises. The relaxation exercises are applied two times a day till the discharge day starting on the postoperative day one. Progressive muscle relaxation included the relaxing of different muscle groups along with deep breathing. The maximal contraction period consist of the contraction of muscle groups around ankle, calf, knee, hip, lumbar, thoracic and cervical regions, shoulder, arm, forearm for 5 s and continued with a relaxation period for 30 s while focusing on breathing. These two periods ware repeated for each muscle groups and lasted approximately 30 min
Standard ExercisesOther
Also called Relaxation Treatment
The physiotherapy protocol is applied under the supervision of the same physiotherapist within a progressive manner immediately after surgery. Continued passive range of motion is applied twice a day starting with 45º of knee flexion range of motion and increased gradually as tolerated. All patients performed same isometric, isotonic and active exercises. Patients were instructed to bear weight as tolerated on the postoperative day 1
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Treatment | Active comparator | Relaxation treatment (RT) is applied additional to standard physiotherapy treatment. RT includes 8 sessions (2 times a day, for four days after surgery) of relaxation exercises. Receives: Other: Standard Exercises |
| Standard Exercises | Active comparator | Standard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. Receives: Other: Relaxation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level Change
Visual analog scale
Measured: Mean change from Postoperative day 1 to day 4 recorded
Secondary outcomes (4)
Sleep Quality Change
Visual analog scale
Measured: Mean change from Postoperative day 1 to day 4 recorded
Functional Outcomes Change
Timed Up and Go
Measured: Mean change from Postoperative day4 to 6 weeks following surgery recorded
Functional Outcomes Change
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Mean change from Postoperative day4 to 6 weeks following surgery recorded
Knee Range of Motion Change
Flexion and Extension
Measured: Mean change from Postoperative day4 to 6 weeks following surgery recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Jan 2015
- Primary completion1 Jan 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relaxation; JointStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE GUNEY, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845204
- Sponsor's protocol ID
- GO 15/77-22
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koken M, Guclu B. The Effects of Total Knee Arthroplasty on Sleep Quality. Malays Orthop J. 2019 Jul;13(2):11-14. doi: 10.5704/MOJ.1907.002.
PubMed 31467645Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.
PubMed 27295978
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Muscle Relaxation Techniques on Pain, Sleeping Quality and Functional Levels After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04845204
- Acronym / sponsor ID
- GO 15/77-22
- Conditions
- Relaxation; Joint, Total Knee Arthroplasty, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 14 Apr 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.
Surgical techniques and treatment methods of the arthroplasty have been improved and the results after total knee arthroplasty (TKA) are generally good. However, some patients have suboptimal postoperative results with respect to pain and physical functioning and may not be satisfied with the results of their TKA. Psychological symptoms were found to be associated with these suboptimal results. The aim of the present study is to determine weather relaxation techniques had beneficial effects on pain, sleeping quality, functional status and physiological symptoms in TKA patients during their hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation Treatment | Active comparator | Other: Standard ExercisesRelaxation treatment (RT) is applied additional to standard physiotherapy treatment. RT includes 8 sessions (2 times a day, for four days after surgery) of relaxation exercises. |
| Standard Exercises | Active comparator | Other: Relaxation TreatmentStandard postoperative rehabilitation program is applied to Control Group. Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary knee osteoarthritis, Female Patients who are scheduled for unilateral Total Knee Arthroplasty surgery, were included in the study.
Key exclusion criteria (1 listed)
- having a previous knee or hip surgery or fracture, diagnosis of rheumatoid arthritis, severe obesity (BMI>40 kg/m2), sensory and motor disorders in the operated limb, inability to understand pain assessment.
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 |
|---|---|---|
| Relaxation TreatmentAlso: Standard ExercisesRelaxation Group recieve progressive muscle relaxation exercises additional to the standard exercises. The relaxation exercises are applied two times a day till the discharge day starting on the postoperative day one. Progressive muscle relaxation included the relaxing of different muscle groups along with deep breathing. The maximal contraction period consist of the contraction of muscle groups around ankle, calf, knee, hip, lumbar, thoracic and cervical regions, shoulder, arm, forearm for 5 s and continued with a relaxation period for 30 s while focusing on breathing. These two periods ware repeated for each muscle groups and lasted approximately 30 min | Other | Standard Exercises |
| Standard ExercisesAlso: Relaxation TreatmentThe physiotherapy protocol is applied under the supervision of the same physiotherapist within a progressive manner immediately after surgery. Continued passive range of motion is applied twice a day starting with 45º of knee flexion range of motion and increased gradually as tolerated. All patients performed same isometric, isotonic and active exercises. Patients were instructed to bear weight as tolerated on the postoperative day 1 | Other | Relaxation Treatment |
Primary outcome
Pain Level Change
Time frame: Mean change from Postoperative day 1 to day 4 recorded
Visual analog scale
4 secondary outcomes
Sleep Quality Change
Time frame: Mean change from Postoperative day 1 to day 4 recorded
Functional Outcomes Change
Time frame: Mean change from Postoperative day4 to 6 weeks following surgery recorded
Functional Outcomes Change
Time frame: Mean change from Postoperative day4 to 6 weeks following surgery recorded
Knee Range of Motion Change
Time frame: Mean change from Postoperative day4 to 6 weeks following surgery recorded
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 14 Apr 2021.
- Background: PubMed 31467645Koken M, Guclu B. The Effects of Total Knee Arthroplasty on Sleep Quality. Malays Orthop J. 2019 Jul;13(2):11-14. doi: 10.5704/MOJ.1907.002.
- Background: PubMed 27295978Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Treatment and Standard Exercises in people with Relaxation; Joint and Total Knee Arthroplasty, run by Hacettepe University.
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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain Level Change (time frame: Mean change from Postoperative day 1 to day 4 recorded). 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 NCT04845204, which also lists 2 linked publications.
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 14 Apr 2021.