Fragility Fracture Integrated Rehabilitation Management (FIRM) (FIRM)

January 14, 2021 updated by: Jae-Young Lim, Seoul National University Bundang Hospital

Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients

A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this prospective study

To develop a standardized fragility fracture integrated rehabilitation management (FIRM) based on the critical rehabilitation pathway for fragility fractures.

  1. Standardization of initial evaluation for fall and re-fracture risks before rehabilitation
  2. Standardization in initial screening for prevention for common complication after fracture and early diagnosis
  3. Evidence based standardization in rehabilitation after fragility fracture
  4. Development for safe return to normal daily life

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • SeongNam, Gyeonggi, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jae-Young Lim, MD, PhD
        • Sub-Investigator:
          • Seung-Kyu Lim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture
  2. Type of surgery : Bipolar hemiarthroplasty, THA, ORIF

Exclusion Criteria:

  1. Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN
  2. Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor
  3. Combined multiple fracture (ex. Upper extremity)
  4. Revision operation
  5. Disagree to participation for clinical trial
  6. Severe cognitive dysfunction (Obey command ≤1)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIRM group
FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.
Other: FIRM

FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward.

PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.
Active Comparator: Conventional group
Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.
Other: Conventional rehabilitation
Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.
No Intervention: No-rehabilitation group
Discharged patients not transferred to rehabilitation unit after surgery for hip fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 0 to 5; decreasingly worse
0, 3 month, 6 month, 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baselines mobility status (KOVAL) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 1 to 7; increasingly worse
0, 3 month, 6 month, 12 month
Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 1 to 7; decreasingly worse
0, 3 month, 6 month, 12 month
Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 0 to 56; decreasingly worse
0, 3 month, 6 month, 12 month
Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 0 to 30; decreasingly worse
0, 3 month, 6 month, 12 month
Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 0 to 30 ; increasingly worse
0, 3 month, 6 month, 12 month
Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 0 to 1; decreasingly worse
0, 3 month, 6 month, 12 month
Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 0 to 100; decreasingly worse
0, 3 month, 6 month, 12 month
Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 0 to 3; increasingly worse
0, 3 month, 6 month, 12 month
Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
range, 0 to 5; increasingly worse
0, 3 month, 6 month, 12 month
Change from baselines hand grip strength after rehabilitation
Time Frame: 0, 3 month, 6 month, 12 month
measured by a a digital dynamometer (TKK 5401 Grip-D; Takei, Niigata, Japan)
0, 3 month, 6 month, 12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 0, 3 month, 6 month, 12 month
Mortality rate from number of dead patients among enrolled for the study
0, 3 month, 6 month, 12 month
Recovery to premorbid ambulatory status
Time Frame: 0, 3 month, 6 month, 12 month
Comparison premorbid ambulatory status with post-rehabilitation ambulatory status at each follow-up period
0, 3 month, 6 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Korea Health Industry Development Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2018

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC15C1189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Fractures

Clinical Trials on FIRM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe