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Fragility Fracture Integrated Rehabilitation Management (FIRM) (FIRM)

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ClinicalTrials.gov Identifier: NCT03430193
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Korea Health Industry Development Institute
Information provided by (Responsible Party):
Jae-Young Lim, Seoul National University Bundang Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Fractures Other: FIRM Other: Conventional rehabilitation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from baselines mobility status (KOVAL) after rehabilitation [ Time Frame: 0, 3 month, 6 month, 12 month ]
    range, 1 to 7; increasingly worse

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)


Other Outcome Measures:
  1. Mortality [ Time Frame: 0, 3 month, 6 month, 12 month ]
    Mortality rate from number of dead patients among enrolled for the study

  2. 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430193


Contacts
Contact: Seung-Kyu Lim, MD +821096045700 flyingmango77@gmail.com
Contact: Bo-Ram KIM +82317877732 bboram2@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
SeongNam, Gyeonggi, Korea, Republic of, 463-707
Contact: Jae-Young Lim, MD, PhD    +82317877732    jaden.lim@gmail.com   
Contact: Seung-Kyu Lim, MD    +821096045700    flyingmango77@gmail.com   
Principal Investigator: Jae-Young Lim, MD, PhD         
Sub-Investigator: Seung-Kyu Lim, MD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Korea Health Industry Development Institute
Investigators
Principal Investigator: Jae-Young Lim, MD, PhD Seoul National University Bundang Hospital

Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jae-Young Lim, Professor, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03430193     History of Changes
Other Study ID Numbers: HC15C1189
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jae-Young Lim, Seoul National University Bundang Hospital:
rehabilitation
multi-disciplinary rehabilitation
clinical pathway
Fragility

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries