Back to resultsEffectiveness of Relaxation and Massage Methods in Proximal Femur Fractures
Primary Purpose
Fracture of Femur
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation
Control
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Femur
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
Sites / Locations
- Fethiye State HospitalRecruiting
- Muğla Sıtkı Koçman Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
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.
The control group will receive conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days).
Outcomes
Primary Outcome Measures
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).
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.
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".
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".
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06018610
First Posted
August 18, 2023
Last Updated
August 25, 2023
Sponsor
Muğla Sıtkı Koçman University
1. Study Identification
Unique Protocol Identification Number
NCT06018610
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Femur
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days).
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
Conventional rehabilitation will be applied to the control group.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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).
Time Frame
Change from Baseline VAS at 3 days
Title
Barthel Index (BI)
Description
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.
Time Frame
Change from Baseline BI at 3 days
Title
EQ-5D-3L Quality of Life Scale
Description
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".
Time Frame
Change from Baseline EQ-5D-3L at 3 days
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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".
Time Frame
Change from Baseline HADS at 3 days
Title
Tampa Scale for Kinesiophobia (TSK)
Description
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Time Frame
Change from Baseline TSK at 3 days
Title
Nottingham Hip Fracture Score (NHFS)
Description
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.
Time Frame
Change from Baseline NHFS at 3 days
Title
Sole sensory testing with Semmes-Weinstein Monofilament
Description
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.
Time Frame
Change from Baseline Semmes-Weinstein Monofilament Test at 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Özden, PhD
Phone
543 433 4593
Ext
+90
Email
fatihozden@mu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet İmerci, MD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serkan Bakırhan, PhD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Süleyman Demirel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatih Özyer, MD
Organizational Affiliation
Fethiye State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fethiye State Hospital
City
Muğla
State/Province
Fethiye
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Phone
543 433 4593
Ext
+90
Email
fatihozden90@gmail.com
Facility Name
Muğla Sıtkı Koçman Training and Research Hospital
City
Muğla
State/Province
Menteşe
ZIP/Postal Code
48000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet İmerci, MD
Phone
506 893 5276
Ext
+90
Email
ahmetimerci@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures
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