Clinical trial NCT06018610: Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures
Official title: Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fracture of Femur
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline VAS at 3 days
measure: Barthel Index (BI)
timeFrame: Change from Baseline BI at 3 days
measure: EQ-5D-3L Quality of Life Scale
timeFrame: Change from Baseline EQ-5D-3L at 3 days
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline HADS at 3 days
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Change from Baseline TSK at 3 days
measure: Nottingham Hip Fracture Score (NHFS)
timeFrame: Change from Baseline NHFS at 3 days
measure: Sole sensory testing with Semmes-Weinstein Monofilament
timeFrame: Change from Baseline Semmes-Weinstein Monofilament Test at 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Fethiye State Hospital
state: Fethiye
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman Training and Research Hospital
state: Menteşe
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Ahmet İmerci, MD
role: STUDY_DIRECTOR
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Serkan Bakırhan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Süleyman Demirel University
name: İsmet Tümtürk, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Fethiye State Hospital
name: Fatih Özyer, MD
role: PRINCIPAL_INVESTIGATOR
References: