Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures

NCT06018610 | Completed

• 1 other identifier: Kalça kırığı
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Fracture of Femur

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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.

Other: Rehabilitation

Control Group

ACTIVE COMPARATOR

The control group will receive conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days).

Other: Control

Interventions

Rehabilitation OTHER

In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group.

Intervention Group

Control OTHER

Conventional rehabilitation will be applied to the control group.

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (2)

Fethiye State Hospital

Muğla, Fethiye, Turkey (Türkiye)

Location

Muğla Sıtkı Koçman Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ahmet İmerci, MD

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

• Fatih Özden, PhD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

• Serkan Bakırhan, PhD

  Ege University

  PRINCIPAL INVESTIGATOR

• İsmet Tümtürk, MSc

  Süleyman Demirel University

  PRINCIPAL INVESTIGATOR

• Fatih Özyer, MD

  Fethiye State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 30, 2023
• Study Start: May 18, 2022
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)