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Fragility Fracture Integrated Rehabilitation Management (FIRM) (FIRM)

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FIRM
Conventional rehabilitation
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring rehabilitation, multi-disciplinary rehabilitation, clinical pathway, Fragility

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

FIRM group

Conventional group

No-rehabilitation group

Arm Description

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.

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.

Discharged patients not transferred to rehabilitation unit after surgery for hip fracture.

Outcomes

Primary Outcome Measures

Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation
range, 0 to 5; decreasingly worse

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2018
Last Updated
January 14, 2021
Sponsor
Seoul National University Bundang Hospital
Collaborators
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03430193
Brief Title
Fragility Fracture Integrated Rehabilitation Management (FIRM)
Acronym
FIRM
Official Title
Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Korea Health Industry Development Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
rehabilitation, multi-disciplinary rehabilitation, clinical pathway, Fragility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FIRM group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No-rehabilitation group
Arm Type
No Intervention
Arm Description
Discharged patients not transferred to rehabilitation unit after surgery for hip fracture.
Intervention Type
Other
Intervention Name(s)
FIRM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation
Description
range, 0 to 5; decreasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Secondary Outcome Measure Information:
Title
Change from baselines mobility status (KOVAL) after rehabilitation
Description
range, 1 to 7; increasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation
Description
range, 1 to 7; decreasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation
Description
range, 0 to 56; decreasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation
Description
range, 0 to 30; decreasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation
Description
range, 0 to 30 ; increasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation
Description
range, 0 to 1; decreasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation
Description
range, 0 to 100; decreasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation
Description
range, 0 to 3; increasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation
Description
range, 0 to 5; increasingly worse
Time Frame
0, 3 month, 6 month, 12 month
Title
Change from baselines hand grip strength after rehabilitation
Description
measured by a a digital dynamometer (TKK 5401 Grip-D; Takei, Niigata, Japan)
Time Frame
0, 3 month, 6 month, 12 month
Other Pre-specified Outcome Measures:
Title
Mortality
Description
Mortality rate from number of dead patients among enrolled for the study
Time Frame
0, 3 month, 6 month, 12 month
Title
Recovery to premorbid ambulatory status
Description
Comparison premorbid ambulatory status with post-rehabilitation ambulatory status at each follow-up period
Time Frame
0, 3 month, 6 month, 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture Type of surgery : Bipolar hemiarthroplasty, THA, ORIF Exclusion Criteria: Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor Combined multiple fracture (ex. Upper extremity) Revision operation Disagree to participation for clinical trial Severe cognitive dysfunction (Obey command ≤1)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Kyu Lim, MD
Phone
+821096045700
Email
flyingmango77@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bo-Ram KIM
Phone
+82317877732
Email
bboram2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
SeongNam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, MD, PhD
Phone
+82317877732
Email
jaden.lim@gmail.com
First Name & Middle Initial & Last Name & Degree
Seung-Kyu Lim, MD
Phone
+821096045700
Email
flyingmango77@gmail.com
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Seung-Kyu Lim, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17074877
Citation
Beaupre LA, Cinats JG, Senthilselvan A, Lier D, Jones CA, Scharfenberger A, Johnston DW, Saunders LD. Reduced morbidity for elderly patients with a hip fracture after implementation of a perioperative evidence-based clinical pathway. Qual Saf Health Care. 2006 Oct;15(5):375-9. doi: 10.1136/qshc.2005.017095.
Results Reference
background
PubMed Identifier
9302897
Citation
Lyons AR. Clinical outcomes and treatment of hip fractures. Am J Med. 1997 Aug 18;103(2A):51S-63S; discussion 63S-64S. doi: 10.1016/s0002-9343(97)90027-9.
Results Reference
result
PubMed Identifier
12777366
Citation
Magaziner J, Fredman L, Hawkes W, Hebel JR, Zimmerman S, Orwig DL, Wehren L. Changes in functional status attributable to hip fracture: a comparison of hip fracture patients to community-dwelling aged. Am J Epidemiol. 2003 Jun 1;157(11):1023-31. doi: 10.1093/aje/kwg081.
Results Reference
result
PubMed Identifier
18070003
Citation
Sellier E, Labarere J, Sevestre MA, Belmin J, Thiel H, Couturier P, Bosson JL; Association pour la Promotion de l'Angiologie Hospitaliere. Risk factors for deep vein thrombosis in older patients: a multicenter study with systematic compression ultrasonography in postacute care facilities in France. J Am Geriatr Soc. 2008 Feb;56(2):224-30. doi: 10.1111/j.1532-5415.2007.01545.x. Epub 2007 Dec 7.
Results Reference
result
PubMed Identifier
11386929
Citation
Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 Jun 6;285(21):2736-42. doi: 10.1001/jama.285.21.2736.
Results Reference
result
PubMed Identifier
16606814
Citation
Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss E, Morrison RS. Early ambulation after hip fracture: effects on function and mortality. Arch Intern Med. 2006 Apr 10;166(7):766-71. doi: 10.1001/archinte.166.7.766.
Results Reference
result
PubMed Identifier
16278174
Citation
Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. doi: 10.1080/09638280500056618.
Results Reference
result
PubMed Identifier
17724548
Citation
Halbert J, Crotty M, Whitehead C, Cameron I, Kurrle S, Graham S, Handoll H, Finnegan T, Jones T, Foley A, Shanahan M; Hip Fracture Rehabilitation Trial Collaborative Group. Multi-disciplinary rehabilitation after hip fracture is associated with improved outcome: A systematic review. J Rehabil Med. 2007 Sep;39(7):507-12. doi: 10.2340/16501977-0102.
Results Reference
result
PubMed Identifier
12807926
Citation
Adunsky A, Lusky A, Arad M, Heruti RJ. A comparative study of rehabilitation outcomes of elderly hip fracture patients: the advantage of a comprehensive orthogeriatric approach. J Gerontol A Biol Sci Med Sci. 2003 Jun;58(6):542-7. doi: 10.1093/gerona/58.6.m542.
Results Reference
result
PubMed Identifier
29768364
Citation
Lee SY, Beom J, Kim BR, Lim SK, Lim JY; Fragility Fracture Rehabilitation Study Group. Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial. Medicine (Baltimore). 2018 May;97(20):e10763. doi: 10.1097/MD.0000000000010763.
Results Reference
derived

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Fragility Fracture Integrated Rehabilitation Management (FIRM)

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