The Effects of Fragility Fracture Integrated Rehabilitation Management

NCT04760756 | Unknown

• 1 other identifier: REC/0045 Anam Aftab
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fractures

Keywords

Activities of daily living; Mobility limitation; Occupational Therapy; Physical Therapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

This refers to Fragility Fracture Integrated Rehabilitation Management

EXPERIMENTAL

This refers to Fragility Fracture Integrated Rehabilitation Management and will include comprehensive rehabilitation program and assessment

Other: Fragility Fracture Integrated Rehabilitation Management

Interventions

Fragility Fracture Integrated Rehabilitation Management OTHER

* 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)

This refers to Fragility Fracture Integrated Rehabilitation Management

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 55 years of age, who underwent hip fracture management NIRM Pakistan due to hip fracture
• Patient diagnosed with femur neck, intertrochanteric fracture, and sub-trochanteric fracture
• Patient who got bipolar hemiarthroplasty, total hip replacement arthroplasty, reduction and internal fixation

You may not qualify if:

• Patients who underwent surgery for a cause other than a hip fracture (infection, arthritis, loosening, avascular necrosis)
• Patients who underwent surgery because of femur shaft fracture, acetabular fracture, periprosthetic fracture pathologic fracture by tumor
• Isolated fracture of the greater or lesser tuberosity
• Multiple fracture
• Revision operation
• Patients who do not agree to participate in clinical trials

Sponsors & Collaborators

• Zohra Institute of Health Sciences: lead

Study Sites (1)

National Institute of Rehabilitation Medicine

Islamabad, 0042, Pakistan

RECRUITING

Related 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.

  PMID: 28286986 BACKGROUND

• 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.

  PMID: 19559412 BACKGROUND

• 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. doi: 10.1002/jbmr.5650090802. No abstract available.

  PMID: 7976495 BACKGROUND

• 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(Suppl 3):1-37. doi: 10.4158/ep.16.s3.1. No abstract available.

  PMID: 21224201 BACKGROUND

• 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. doi: 10.1093/ajcn/85.3.853.

  PMID: 17344509 BACKGROUND

• 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. doi: 10.2165/00007256-199519050-00004.

  PMID: 7618011 BACKGROUND

• 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.

  PMID: 20842676 BACKGROUND

• 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.

  PMID: 19028351 BACKGROUND

• 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. doi: 10.1007/s00198-011-1876-7.

  PMID: 22314936 BACKGROUND

• 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.

  PMID: 18292978 BACKGROUND

• Cummings SR, Kelsey JL, Nevitt MC, O'Dowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7:178-208. doi: 10.1093/oxfordjournals.epirev.a036281. No abstract available.

  PMID: 3902494 BACKGROUND

• Riggs BL, Melton LJ 3rd. The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone. 1995 Nov;17(5 Suppl):505S-511S. doi: 10.1016/8756-3282(95)00258-4.

  PMID: 8573428 BACKGROUND

• 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. No abstract available.

  PMID: 23569668 BACKGROUND

• 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. doi: 10.1046/j.1532-5415.2003.51185.x.

  PMID: 12657078 BACKGROUND

• 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.

  PMID: 21058002 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.

  PMID: 12821592 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Mobility Limitation

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anam Aftab, Phd*

  Riphah college of rehabilitation and allied health sciences - Rawalpindi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaista Habibullah, PhD

CONTACT

03362291027; shaista.habibullah2014@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: July 15, 2019
• Primary Completion: July 20, 2021
• Study Completion: July 30, 2021
• Last Updated: February 18, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)