Fragility Fracture Integrated Rehabilitation Management (FIRM)

NCT ID: NCT03430193

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2021-09-30

Brief Summary

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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

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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

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

FIRM

Intervention Type OTHER

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 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.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

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-rehabilitation group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Young Lim

Professor, Department of Rehabilitation Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Young Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seung-Kyu Lim, MD

Role: CONTACT

+821096045700

Bo-Ram KIM

Role: CONTACT

+82317877732

Facility Contacts

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Jae-Young Lim, MD, PhD

Role: primary

+82317877732

Seung-Kyu Lim, MD

Role: backup

+821096045700

References

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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.

Reference Type BACKGROUND
PMID: 17074877 (View on PubMed)

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.

Reference Type RESULT
PMID: 9302897 (View on PubMed)

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.

Reference Type RESULT
PMID: 12777366 (View on PubMed)

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.

Reference Type RESULT
PMID: 18070003 (View on PubMed)

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.

Reference Type RESULT
PMID: 11386929 (View on PubMed)

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.

Reference Type RESULT
PMID: 16606814 (View on PubMed)

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.

Reference Type RESULT
PMID: 16278174 (View on PubMed)

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.

Reference Type RESULT
PMID: 17724548 (View on PubMed)

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.

Reference Type RESULT
PMID: 12807926 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29768364 (View on PubMed)

Other Identifiers

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HC15C1189

Identifier Type: -

Identifier Source: org_study_id

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