Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures

NCT ID: NCT06018610

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2025-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

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

Control Group

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Conventional rehabilitation will be applied to the control group.

Interventions

Rehabilitation

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

Intervention Type: OTHER

Control

Conventional rehabilitation will be applied to the control group.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: lead

Responsible Party

Fatih Ozden

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet İmerci, MD

Role: STUDY_DIRECTOR

Muğla Sıtkı Koçman University

Fatih Özden, PhD

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Serkan Bakırhan, PhD

Role: PRINCIPAL_INVESTIGATOR

Ege University

İsmet Tümtürk, MSc

Role: PRINCIPAL_INVESTIGATOR

Süleyman Demirel University

Fatih Özyer, MD

Role: PRINCIPAL_INVESTIGATOR

Fethiye State Hospital

Locations

Fethiye State Hospital

Muğla, Fethiye, Turkey (Türkiye)

Muğla Sıtkı Koçman Training and Research Hospital

Muğla, Menteşe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Kalça kırığı

Identifier Type: -

Identifier Source: org_study_id