Fracture of FemurNCT06018610
Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures
A study testing Rehabilitation in people with Fracture of Femur, run by Muğla Sıtkı Koçman University at 2 sites in Turkey (Türkiye).
Trial summary
The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and who have undergone proximal femur fracture surgery and meet the study criteria. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Fracture of Femur
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 May 2022to 1 Oct 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 50 years and older who were diagnosed with proximal femur fracture and underwent surgery
- No medical contraindications that would limit the ability to exercise
- Having a caregiver who can supervise the exercise program after discharge
- To be able to understand simple commands and to have signed the consent form
Who cannot join
- Patients with pathological fractures and/or multiple fractures
- Those with serious early complications
- Terminally ill patients
- Circumstances that would interfere with conducting assessments or communicating
- Lack of cooperation during the study
- Scoring ≤14 on the Mini Mental State Examinatio
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Fethiye State Hospital
Muğla, Fethiye
Muğla Sıtkı Koçman Training and Research Hospital
Muğla, Menteşe, 48000
About this study
Official title: Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures
The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and who have undergone proximal femur fracture surgery and meet the study criteria. It is aimed to investigate the mid-term efficacy of relaxation exercises and classical massage of the sole of the foot applied in addition to the conventional physiotherapy program in the postoperative in-hospital period in patients with proximal femur fracture.
- Conditions
- Fracture of Femur
- Being tested
- Rehabilitation, Control
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group.
ControlOther
Conventional rehabilitation will be applied to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group. Patients will be re-evaluated 3 days after the completion of the interventions. Receives: Other: Rehabilitation |
| Control Group | Active comparator | The control group will receive conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Measured: Change from Baseline VAS at 3 days
Barthel Index (BI)
The Barthel Index was developed as a measure to assess disability in patients with neuromuscular and musculoskeletal disorders undergoing inpatient rehabilitation. A maximum total score of 100 can be obtained. Higher score indicates better condition.
Measured: Change from Baseline BI at 3 days
EQ-5D-3L Quality of Life Scale
The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".
Measured: Change from Baseline EQ-5D-3L at 3 days
Hospital Anxiety and Depression Scale (HADS)
The HADS consists of two subscales, one with seven items measuring anxiety and the other with seven items measuring depression, which are scored separately. Each item is answered by the patient on a 4-point response category (0 to 3), so that possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. 0 to 7 is considered "normal", 8 to 10 "mild", 11 to 14 "moderate" and 15 to 21 "severe".
Measured: Change from Baseline HADS at 3 days
Tampa Scale for Kinesiophobia (TSK)
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Measured: Change from Baseline TSK at 3 days
Nottingham Hip Fracture Score (NHFS)
The Nottingham Hip Fracture Score is an aggregate score of seven preoperative variables that gives an estimated risk of 30-day postoperative mortality using a standard logistic regression. This score is calculated based on age, gender, comorbidities, place of residence (i.e. home or institutional care), abbreviated mental test score (AMTS) and hemoglobin level at admission. Higher scores indicate better condition.
Measured: Change from Baseline NHFS at 3 days
Sole sensory testing with Semmes-Weinstein Monofilament
The filament is imposed horizontally against the skin until there is a visible bending of the fiber. The patient then verbally assesses whether the sensation is perceived. Starting with the thinnest filament, thick filament is used sequentially until the patient feels it.
Measured: Change from Baseline Semmes-Weinstein Monofilament Test at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start18 May 2022
- Primary completion1 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of FemurStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Ahmet İmerci, MD, Study director, Muğla Sıtkı Koçman UniversityFatih Özden, PhD, Principal investigator, Muğla Sıtkı Koçman UniversitySerkan Bakırhan, PhD, Principal investigator, Ege Universityİsmet Tümtürk, MSc, Principal investigator, Süleyman Demirel UniversityFatih Özyer, MD, Principal investigator, Fethiye State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018610
- Sponsor's protocol ID
- Kalça kırığı
- Status last verified
- Dec 2025
- First submitted
- 18 Aug 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures
- ClinicalTrials.gov ID
- NCT06018610
- Acronym / sponsor ID
- Kalça kırığı
- Conditions
- Fracture of Femur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 30 Aug 2023 (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.
The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and who have undergone proximal femur fracture surgery and meet the study criteria. It is aimed to investigate the mid-term efficacy of relaxation exercises and classical massage of the sole of the foot applied in addition to the conventional physiotherapy program in the postoperative in-hospital period in patients with proximal femur fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: RehabilitationIn addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group. Patients will be re-evaluated 3 days after the completion of the interventions. |
| Control Group | Active comparator | Other: ControlThe control group will receive conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients aged 50 years and older who were diagnosed with proximal femur fracture and underwent surgery
- No medical contraindications that would limit the ability to exercise
- Having a caregiver who can supervise the exercise program after discharge
- To be able to understand simple commands and to have signed the consent form
Key exclusion criteria (6 listed)
- Patients with pathological fractures and/or multiple fractures
- Those with serious early complications
- Terminally ill patients
- Circumstances that would interfere with conducting assessments or communicating
- Lack of cooperation during the study
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 |
|---|---|---|
| RehabilitationIn addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group. | Other | Intervention Group |
| ControlConventional rehabilitation will be applied to the control group. | Other | Control Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Change from Baseline VAS at 3 days
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Barthel Index (BI)
Time frame: Change from Baseline BI at 3 days
The Barthel Index was developed as a measure to assess disability in patients with neuromuscular and musculoskeletal disorders undergoing inpatient rehabilitation. A maximum total score of 100 can be obtained. Higher score indicates better condition.
EQ-5D-3L Quality of Life Scale
Time frame: Change from Baseline EQ-5D-3L at 3 days
The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from Baseline HADS at 3 days
The HADS consists of two subscales, one with seven items measuring anxiety and the other with seven items measuring depression, which are scored separately. Each item is answered by the patient on a 4-point response category (0 to 3), so that possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. 0 to 7 is considered "normal", 8 to 10 "mild", 11 to 14 "moderate" and 15 to 21 "severe".
Tampa Scale for Kinesiophobia (TSK)
Time frame: Change from Baseline TSK at 3 days
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Nottingham Hip Fracture Score (NHFS)
Time frame: Change from Baseline NHFS at 3 days
The Nottingham Hip Fracture Score is an aggregate score of seven preoperative variables that gives an estimated risk of 30-day postoperative mortality using a standard logistic regression. This score is calculated based on age, gender, comorbidities, place of residence (i.e. home or institutional care), abbreviated mental test score (AMTS) and hemoglobin level at admission. Higher scores indicate better condition.
Sole sensory testing with Semmes-Weinstein Monofilament
Time frame: Change from Baseline Semmes-Weinstein Monofilament Test at 3 days
The filament is imposed horizontally against the skin until there is a visible bending of the fiber. The patient then verbally assesses whether the sensation is perceived. Starting with the thinnest filament, thick filament is used sequentially until the patient feels it.
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 15 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Fracture of Femur
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
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.
Ahmet İmerci, MD study director
Muğla Sıtkı Koçman University
Fatih Özden, PhD principal investigator
Muğla Sıtkı Koçman University
Serkan Bakırhan, PhD principal investigator
Ege University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Fracture of Femur, run by Muğla Sıtkı Koçman University at 2 sites 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 4 inclusion and 6 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual Analog Scale (VAS) (time frame: Change from Baseline VAS at 3 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.