Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures

Conditions
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Fracture of Femur

Intervention / Treatment
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* Other: Rehabilitation
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Other: Rehabilitation<br>* In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group.<br>|
| Active Comparator: Control Group<br>The control group will receive conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days). | Other: Control<br>* Conventional rehabilitation will be applied to the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | Change from Baseline Semmes-Weinstein Monofilament Test at 3 days |