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| Name | Class |
|---|---|
| University of Bologna | OTHER |
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The present study aims to evaluate the modification of functional capacity induced by an adapted physical activity program in subjects with haemophilia.
The exercise program used aims to improve joint mobility, muscle strength, static and dynamic balance, motor coordination.
The program is structured in 1 hour sessions of 2 days/week and lasts 6 months.
The primary endpoint is the change in functional capacity calculated as the difference between the baseline assessment and the 3 and 6 month assessment of the 6 Minutes Walking Test measured with the G-Walk (BTS Bioengineering S.p.A).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | Experimental | patients with emophilia receiving a program of adapted physical activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFA (Adapted Physical Activity) | Other | An exercise program to improve joint mobility, muscle strength, static and dynamic balance, motor coordination will be performed 2 times/week for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minutes Walking Test | The change in functional capacity calculated as the difference between the baseline 6 Minutes Walking Test assessment and the 3 and 6 month assessment measured with the G-Walk (BTS Bioengineering S.p.A). | baseline,3 months,6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Score in Hemophilia (FISH) | It is a questionnaire which is carried out by an operator to evaluate autonomy in carrying out eight activities of daily life: personal hygiene, eating, dressing, transferring from chairs, squatting, walking, climbing stairs, running. Each activity is measured according to the amount of assistance needed to perform it. | baseline,3 months,6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | Bo | 40130 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31499529 | Background | Iorio A, Stonebraker JS, Chambost H, Makris M, Coffin D, Herr C, Germini F; Data and Demographics Committee of the World Federation of Hemophilia. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries. Ann Intern Med. 2019 Oct 15;171(8):540-546. doi: 10.7326/M19-1208. Epub 2019 Sep 10. | |
| Background | Lee CA, Berntorp EE, Keith Hoots W; Textbook of Hemophilia 3th Edition 2014 Wiley Ed; | ||
| 17943258 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2023 | Aug 27, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Hemophilia joint health score (HJHS) | It is a scale compiled by an operator to evaluate the health status of the joints. The HJHS measures joint health in the domains of body structure and function (biomechanics) of the structures most frequently affected by hemorrhage in patients with hemophilia: the knees, ankles, and elbows. | baseline,3 months,6 months |
| Tampa Scale of Kinesiophobia - (TSK) | It is a questionnaire filled in by the patient to assess fear of movement. This scale is an international evaluation parameter with which a persistent and constant, completely unjustified concern in carrying out movements for fear of causing pain or damage is highlighted. | baseline,3 months,6 months |
| Hemophilia Activity List (HAL) | It is a questionnaire filled in by the patient on activity limitations. The HAL scale measures the impact of haemophilia on functional abilities in adults. It is made up of 42 questions investigating 7 domains: 1. Lying / Sitting / Kneeling / Standing, 2. Leg functions, 3. Arm functions, 4. Transport, 5. Personal care, 6. Household activities, 7. Leisure and sporting activities. | baseline,3 months,6 months |
| Balance - Single leg stand test | The test should be performed with eyes open and hands on the hips. Instruct the patient to stand on one leg unassisted, starting when the patient's foot leaves the ground and stopping the time the patient's foot touches the ground and/or when their hands leave the hips. Abnormal values may indicate conditions such as peripheral neuropathy, intermittent claudication, or other conditions that may impair balance | baseline,3 months,6 months |
| Balance - Time Up and Go (TUG) | The TUG is a general physical performance test used to assess mobility, balance and locomotor performance in people with potential balance disturbances. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning. | baseline,3 months,6 months |
| Pain (VAS - Visual Analogue Scale ) | Pain measured by VAS (Visual Analogue Scale) on target joint | baseline,3 months,6 months |
| Muscle strenght- 30" Chair stand test | The purpose of this test in to evaluate leg strength and endurance, by counting the number of times the patient comes to a full standing position in 30 seconds | baseline,3 months,6 months |
| Muscle strenght-Arm curl test | this test evaluates functional upper extremity fitness of adults, with the goal is to complete as many curls (through the entire available range of motion) in 30 seconds | baseline,3 months,6 months |
| Muscle strenght- Hand held measuring of hip and knee flexors/extensors | Measure the muscle strenght of hip and knee flexors/extensors by using a Hand held | baseline,3 months,6 months |
| Background |
| Gurcay E, Eksioglu E, Ezer U, Cakir B, Cakci A. A prospective series of musculoskeletal system rehabilitation of arthropathic joints in young male hemophilic patients. Rheumatol Int. 2008 Apr;28(6):541-5. doi: 10.1007/s00296-007-0474-7. Epub 2007 Oct 18. |
| 19804383 | Background | Hill K, Fearn M, Williams S, Mudge L, Walsh C, McCarthy P, Walsh M, Street A. Effectiveness of a balance training home exercise programme for adults with haemophilia: a pilot study. Haemophilia. 2010 Jan;16(1):162-9. doi: 10.1111/j.1365-2516.2009.02110.x. Epub 2009 Oct 5. |
| 22776238 | Background | Srivastava A, Brewer AK, Mauser-Bunschoten EP, Key NS, Kitchen S, Llinas A, Ludlam CA, Mahlangu JN, Mulder K, Poon MC, Street A; Treatment Guidelines Working Group on Behalf of The World Federation Of Hemophilia. Guidelines for the management of hemophilia. Haemophilia. 2013 Jan;19(1):e1-47. doi: 10.1111/j.1365-2516.2012.02909.x. Epub 2012 Jul 6. |
| 11858624 | Background | Nied RJ, Franklin B. Promoting and prescribing exercise for the elderly. Am Fam Physician. 2002 Feb 1;65(3):419-26. |
| 15897310 | Background | Bennell KL, Hinman RS, Metcalf BR, Buchbinder R, McConnell J, McColl G, Green S, Crossley KM. Efficacy of physiotherapy management of knee joint osteoarthritis: a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2005 Jun;64(6):906-12. doi: 10.1136/ard.2004.026526. |
| 20203091 | Background | Mulvany R, Zucker-Levin AR, Jeng M, Joyce C, Tuller J, Rose JM, Dugdale M. Effects of a 6-week, individualized, supervised exercise program for people with bleeding disorders and hemophilic arthritis. Phys Ther. 2010 Apr;90(4):509-26. doi: 10.2522/ptj.20080202. Epub 2010 Mar 4. |
| 18721151 | Background | Gomis M, Querol F, Gallach JE, Gonzalez LM, Aznar JA. Exercise and sport in the treatment of haemophilic patients: a systematic review. Haemophilia. 2009 Jan;15(1):43-54. doi: 10.1111/j.1365-2516.2008.01867.x. Epub 2008 Aug 21. |
| 8980206 | Background | Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31. |
| 15769914 | Background | Roddy E, Zhang W, Doherty M. Aerobic walking or strengthening exercise for osteoarthritis of the knee? A systematic review. Ann Rheum Dis. 2005 Apr;64(4):544-8. doi: 10.1136/ard.2004.028746. |
| 12180738 | Background | Fransen M, McConnell S, Bell M. Therapeutic exercise for people with osteoarthritis of the hip or knee. A systematic review. J Rheumatol. 2002 Aug;29(8):1737-45. |
| 19588445 | Background | Fransen M, McConnell S, Hernandez-Molina G, Reichenbach S. Exercise for osteoarthritis of the hip. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007912. doi: 10.1002/14651858.CD007912. |
| Background | World Federation Guidelines of Hemophilia - 2nd Edition |
| 31667968 | Background | Siqueira TC, Dominski FH, Andrade A. Effects of exercise in people with haemophilia: An umbrella review of systematic reviews and meta-analyses. Haemophilia. 2019 Nov;25(6):928-937. doi: 10.1111/hae.13868. Epub 2019 Oct 30. |
| 34687122 | Background | Deniz V, Guzel NA, Lobet S, Antmen AB, Sasmaz HI, Kilci A, Boyraz OC, Gunasti O, Kurdak SS. Effects of a supervised therapeutic exercise program on musculoskeletal health and gait in patients with haemophilia: A pilot study. Haemophilia. 2022 Jan;28(1):166-175. doi: 10.1111/hae.14444. Epub 2021 Oct 22. |
| 16236109 | Background | Poonnoose PM, Manigandan C, Thomas R, Shyamkumar NK, Kavitha ML, Bhattacharji S, Srivastava A. Functional Independence Score in Haemophilia: a new performance-based instrument to measure disability. Haemophilia. 2005 Nov;11(6):598-602. doi: 10.1111/j.1365-2516.2005.01142.x. |
| 31294328 | Background | Ribeiro T, Abad A, Feldman BM. Developing a new scoring scheme for the Hemophilia Joint Health Score 2.1. Res Pract Thromb Haemost. 2019 May 20;3(3):405-411. doi: 10.1002/rth2.12212. eCollection 2019 Jul. |
| 20216338 | Background | Monticone M, Giorgi I, Baiardi P, Barbieri M, Rocca B, Bonezzi C. Development of the Italian version of the Tampa Scale of Kinesiophobia (TSK-I): cross-cultural adaptation, factor analysis, reliability, and validity. Spine (Phila Pa 1976). 2010 May 20;35(12):1241-6. doi: 10.1097/BRS.0b013e3181bfcbf6. |
| 16409173 | Background | van Genderen FR, Westers P, Heijnen L, de Kleijn P, van den Berg HM, Helders PJ, van Meeteren NL. Measuring patients' perceptions on their functional abilities: validation of the Haemophilia Activities List. Haemophilia. 2006 Jan;12(1):36-46. doi: 10.1111/j.1365-2516.2006.01186.x. |
| 19542782 | Background | Benton MJ, Alexander JL. Validation of functional fitness tests as surrogates for strength measurement in frail, older adults with chronic obstructive pulmonary disease. Am J Phys Med Rehabil. 2009 Jul;88(7):579-83; quiz 584-6, 590. doi: 10.1097/PHM.0b013e3181aa2ff8. |
| 21829128 | Background | Hebert LJ, Maltais DB, Lepage C, Saulnier J, Crete M, Perron M. Isometric muscle strength in youth assessed by hand-held dynamometry: a feasibility, reliability, and validity study. Pediatr Phys Ther. 2011 Fall;23(3):289-99. doi: 10.1097/PEP.0b013e318227ccff. |
| 20391504 | Background | Hunt MA, McManus FJ, Hinman RS, Bennell KL. Predictors of single-leg standing balance in individuals with medial knee osteoarthritis. Arthritis Care Res (Hoboken). 2010 Apr;62(4):496-500. doi: 10.1002/acr.20046. |
| 1991946 | Background | Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. |
| 18467932 | Background | Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93. |
| Background | Louangrath, Paul. (2018). Reliability and Validity of Survey Scales. 10.5281/zenodo.1322695. |
| Background | World Health Organization. Global action plan on physical activity 2018-2030: more active people for a healthier world. 2018. http://apps.who.int/iris/bitstream/handle/10665/272722/9789241514187-eng.pdf |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |