Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia

NCT06580340 | Recruiting

• 1 other identifier: EMO- AFA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hemophilia; Sports Physical Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Functional Independence Score in Hemophilia (FISH)

  baseline,3 months,6 months

• Hemophilia joint health score (HJHS)

  baseline,3 months,6 months

• Tampa Scale of Kinesiophobia - (TSK)

  baseline,3 months,6 months

• Hemophilia Activity List (HAL)

  baseline,3 months,6 months

• Balance - Single leg stand test

  baseline,3 months,6 months

Study Arms (1)

patients

EXPERIMENTAL

patients with emophilia receiving a program of adapted physical activity

Other: AFA (Adapted Physical Activity)

Interventions

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.

patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of hemophilia A or B;
• Signature of informed consent;
• Availability of a medical certificate for non-competitive activities

You may not qualify if:

• Active bleeding
• Severe joint deformities that prevent exercise
• Insufficiency of communicative and/or sensory functions so severe that it is impossible to understand or carry out the trainer's instructions (dementia, aphasia, blindness, deafness)
• Heart failure (NYHA class \> 2)
• Unstable angina
• Lung disease requiring oxygen therapy
• Symptomatic peripheral arterial disease
• Myocardial infarction or hospitalization within the previous 6 months
• Symptomatic orthostatic hypotension
• Hypertension in poor pharmacological control (diastolic\> 95 mmHg, systolic\> 160 mmHg)
• Significant neurological conditions that impair motor or cognitive function

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• University of Bologna: collaborator

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Bo, 40130, Italy

RECRUITING

Related Publications (27)

• 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.

  PMID: 31499529 BACKGROUND

• Lee CA, Berntorp EE, Keith Hoots W; Textbook of Hemophilia 3th Edition 2014 Wiley Ed;

  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.

  PMID: 17943258 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.

  PMID: 19804383 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.

  PMID: 22776238 BACKGROUND

• Nied RJ, Franklin B. Promoting and prescribing exercise for the elderly. Am Fam Physician. 2002 Feb 1;65(3):419-26.

  PMID: 11858624 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.

  PMID: 15897310 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.

  PMID: 20203091 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.

  PMID: 18721151 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.

  PMID: 8980206 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.

  PMID: 15769914 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.

  PMID: 12180738 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.

  PMID: 19588445 BACKGROUND

• World Federation Guidelines of Hemophilia - 2nd Edition

  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.

  PMID: 31667968 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.

  PMID: 34687122 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.

  PMID: 16236109 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.

  PMID: 31294328 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.

  PMID: 20216338 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.

  PMID: 16409173 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.

  PMID: 19542782 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.

  PMID: 21829128 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.

  PMID: 20391504 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.

  PMID: 1991946 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.

  PMID: 18467932 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

  BACKGROUND

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 30, 2024
• Study Start: September 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)