The Effects of Fragility Fracture Integrated Rehabilitation Management

Hip Fractures Clinical Trial

Official title:

The Effects of Fragility Fracture Integrated Rehabilitation Management (FIRM) of Hip Fracture in Geriatrics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760756
• Other study ID #: REC/0045 Anam Aftab
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2020
• Source: Zohra Institute of Health Sciences
• Contact: Shaista Habibullah, PhD
• Phone: 03362291027
• Email: shaista.habibullah2014[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• To determine the effects of Fragility Fracture Integrated Rehabilitation Management approach in geriatric hip fracture patients (post surgical)

Description:

This refers to Fragility Fracture Integrated Rehabilitation Management and will include following comprehensive rehabilitation program including rehab specialist, physiotherapist, occupational therapist and rehab nurse.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 30, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Patients above 55 years of age, who underwent hip fracture management NIRM Pakistan due to hip fracture

2. Patient diagnosed with femur neck, intertrochanteric fracture, and sub-trochanteric fracture

3. Patient who got bipolar hemiarthroplasty, total hip replacement arthroplasty, reduction and internal fixation

Exclusion Criteria:

1. Patients who underwent surgery for a cause other than a hip fracture (infection, arthritis, loosening, avascular necrosis)

2. Patients who underwent surgery because of femur shaft fracture, acetabular fracture, periprosthetic fracture pathologic fracture by tumor

3. Isolated fracture of the greater or lesser tuberosity

4. Multiple fracture

5. Revision operation

6. Patients who do not agree to participate in clinical trials

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Fragility Fracture Integrated Rehabilitation Management
At least 2 hours of rehabilitation management per day Including occupational therapy (training to improve daily life performance) Inpatient (the first 2 weeks): daily management (body control ability, mobility ability, hygiene management, etc.) Outpatient (2-6 weeks): management once a week The management period is for 2 weeks (1 week after surgery)

Locations

Country	Name	City	State
Pakistan	National Institute of Rehabilitation Medicine	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Zohra Institute of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (16)

Boschitsch EP, Durchschlag E, Dimai HP. Age-related prevalence of osteoporosis and fragility fractures: real-world data from an Austrian Menopause and Osteoporosis Clinic. Climacteric. 2017 Apr;20(2):157-163. doi: 10.1080/13697137.2017.1282452. Epub 2017 Feb 8. — View Citation

Bukata SV, Digiovanni BF, Friedman SM, Hoyen H, Kates A, Kates SL, Mears SC, Mendelson DA, Serna FH Jr, Sieber FE, Tyler WK. A guide to improving the care of patients with fragility fractures. Geriatr Orthop Surg Rehabil. 2011 Jan;2(1):5-37. doi: 10.1177/2151458510397504. — View Citation

Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):549-55. Review. — View Citation

Cummings SR, Kelsey JL, Nevitt MC, O'Dowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7:178-208. Review. — View Citation

Devereux G, Litonjua AA, Turner SW, Craig LC, McNeill G, Martindale S, Helms PJ, Seaton A, Weiss ST. Maternal vitamin D intake during pregnancy and early childhood wheezing. Am J Clin Nutr. 2007 Mar;85(3):853-9. — View Citation

Holroyd C, Cooper C, Dennison E. Epidemiology of osteoporosis. Best Pract Res Clin Endocrinol Metab. 2008 Oct;22(5):671-85. doi: 10.1016/j.beem.2008.06.001. Review. — View Citation

Kanis JA, Johnell O, Oden A, Johansson H, McCloskey E. FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int. 2008 Apr;19(4):385-97. doi: 10.1007/s00198-007-0543-5. Epub 2008 Feb 22. — View Citation

Kanis JA, Melton LJ 3rd, Christiansen C, Johnston CC, Khaltaev N. The diagnosis of osteoporosis. J Bone Miner Res. 1994 Aug;9(8):1137-41. — View Citation

Kates SL, Mendelson DA, Friedman SM. Co-managed care for fragility hip fractures (Rochester model). Osteoporos Int. 2010 Dec;21(Suppl 4):S621-5. doi: 10.1007/s00198-010-1417-9. Epub 2010 Nov 6. — View Citation

Khan K, Brown J, Way S, Vass N, Crichton K, Alexander R, Baxter A, Butler M, Wark J. Overuse injuries in classical ballet. Sports Med. 1995 May;19(5):341-57. Review. — View Citation

Nanes MS, Kallen CB. Clinical assessment of fracture risk and novel therapeutic strategies to combat osteoporosis. Fertil Steril. 2009 Aug;92(2):403-12. doi: 10.1016/j.fertnstert.2009.05.049. Epub 2009 Jun 25. Review. — View Citation

Riggs BL, Melton LJ 3rd. The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone. 1995 Nov;17(5 Suppl):505S-511S. Review. — View Citation

Shane E, Burr D, Ebeling PR, Abrahamsen B, Adler RA, Brown TD, Cheung AM, Cosman F, Curtis JR, Dell R, Dempster D, Einhorn TA, Genant HK, Geusens P, Klaushofer K, Koval K, Lane JM, McKiernan F, McKinney R, Ng A, Nieves J, O'Keefe R, Papapoulos S, Sen HT, van der Meulen MC, Weinstein RS, Whyte M; American Society for Bone and Mineral Research. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2010 Nov;25(11):2267-94. doi: 10.1002/jbmr.253. Erratum in: J Bone Miner Res. 2011 Aug;26(8):1987. — View Citation

Shepstone L, Fordham R, Lenaghan E, Harvey I, Cooper C, Gittoes N, Heawood A, Peters T, O'Neill T, Torgerson D, Holland R, Howe A, Marshall T, Kanis J, McCloskey E. A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening older women for the prevention of fractures: rationale, design and methods for the SCOOP study. Osteoporos Int. 2012 Oct;23(10):2507-15. — View Citation

Thompson PD, Buchner D, Pina IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK; American Heart Association Council on Clinical Cardiology Subcommittee on Exercise, Rehabilitation, and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism Subcommittee on Physical Activity. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation. 2003 Jun 24;107(24):3109-16. — View Citation

Watts NB, Bilezikian JP, Camacho PM, Greenspan SL, Harris ST, Hodgson SF, Kleerekoper M, Luckey MM, McClung MR, Pollack RP, Petak SM; AACE Osteoporosis Task Force. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract. 2010 Nov-Dec;16 Suppl 3:1-37. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Ambulatory Category (FAC)	The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device	2 weeks
Primary	EQ-5D	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	2 weeks
Primary	Modified Barthel index (MBI)	Modified Barthel ADL index Measure of physical disability used widely to assess behaviour relating to activities of daily living for patients with disabling conditions. It measures what patients do in practice.	2 weeks