HemophiliaEMO-AFANCT06580340
Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia
A study testing AFA (Adapted Physical Activity) in people with Hemophilia and Sports Physical Therapy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemophilia, Sports Physical Therapy
- What is being tested?
- AFA (Adapted Physical Activity)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2024to 27 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hemophilia A or B;
- Signature of informed consent;
- Availability of a medical certificate for non-competitive activities
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia:a Prospective Interventional Study
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
- Being tested
- AFA (Adapted Physical Activity)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | patients with emophilia receiving a program of adapted physical activity Receives: Other: AFA (Adapted Physical Activity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline,3 months,6 months
Secondary outcomes (10)
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.
Measured: baseline,3 months,6 months
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline,3 months,6 months
Pain (VAS - Visual Analogue Scale )
Pain measured by VAS (Visual Analogue Scale) on target joint
Measured: 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
Measured: 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
Measured: 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
Measured: baseline,3 months,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start10 Sep 2024
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580340
- Sponsor's protocol ID
- EMO- AFA
- Acronym
- EMO-AFA
- Status last verified
- May 2026
- First submitted
- 23 Aug 2024
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31499529Lee CA, Berntorp EE, Keith Hoots W; Textbook of Hemophilia 3th Edition 2014 Wiley Ed;
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.
PubMed 17943258Hill 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.
PubMed 19804383Srivastava 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.
PubMed 22776238Nied RJ, Franklin B. Promoting and prescribing exercise for the elderly. Am Fam Physician. 2002 Feb 1;65(3):419-26.
PubMed 11858624Bennell 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.
PubMed 15897310Mulvany 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.
PubMed 20203091Gomis 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.
PubMed 18721151Ettinger 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.
PubMed 8980206Roddy 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.
PubMed 15769914Fransen 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.
PubMed 12180738Fransen 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.
PubMed 19588445World Federation Guidelines of Hemophilia - 2nd Edition
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.
PubMed 31667968
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia:a Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT06580340
- Acronym / sponsor ID
- EMO-AFA / EMO- AFA
- Conditions
- Hemophilia, Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: AFA (Adapted Physical Activity)patients with emophilia receiving a program of adapted physical activity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of hemophilia A or B;
- Signature of informed consent;
- Availability of a medical certificate for non-competitive activities
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFA (Adapted Physical Activity)An exercise program to improve joint mobility, muscle strength, static and dynamic balance, motor coordination will be performed 2 times/week for 6 months. | Other | patients |
Primary outcome
6 Minutes Walking Test
Time frame: baseline,3 months,6 months
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).
10 secondary outcomes
Functional Independence Score in Hemophilia (FISH)
Time frame: baseline,3 months,6 months
Hemophilia joint health score (HJHS)
Time frame: baseline,3 months,6 months
Tampa Scale of Kinesiophobia - (TSK)
Time frame: baseline,3 months,6 months
Hemophilia Activity List (HAL)
Time frame: baseline,3 months,6 months
Balance - Single leg stand test
Time frame: baseline,3 months,6 months
Balance - Time Up and Go (TUG)
Time frame: baseline,3 months,6 months
Pain (VAS - Visual Analogue Scale )
Time frame: baseline,3 months,6 months
Muscle strenght- 30" Chair stand test
Time frame: baseline,3 months,6 months
Muscle strenght-Arm curl test
Time frame: baseline,3 months,6 months
Muscle strenght- Hand held measuring of hip and knee flexors/extensors
Time frame: baseline,3 months,6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 31499529Iorio 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.
- BackgroundLee CA, Berntorp EE, Keith Hoots W; Textbook of Hemophilia 3th Edition 2014 Wiley Ed;
- Background: PubMed 17943258Gurcay 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.
- Background: PubMed 19804383Hill 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.
- Background: PubMed 22776238Srivastava 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.
- Background: PubMed 11858624Nied RJ, Franklin B. Promoting and prescribing exercise for the elderly. Am Fam Physician. 2002 Feb 1;65(3):419-26.
- Background: PubMed 15897310Bennell 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.
- Background: PubMed 20203091Mulvany 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.
- Background: PubMed 18721151Gomis 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.
- Background: PubMed 8980206Ettinger 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.
- Background: PubMed 15769914Roddy 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.
- Background: PubMed 12180738Fransen 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.
- Individual participant dataSharing planned: No
Related trials for Hemophilia
Not yet recruitingPhase 1
Lentiviral FIX Gene Therapy
Hemophilia B
Not yet recruitingPhase 1
Lentiviral FVIII Gene Therapy
Hemophilia A
RecruitingPhase 1/2
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Hemophilia A, Healthy Adult Participants
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFA (Adapted Physical Activity) in people with Hemophilia and Sports Physical Therapy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minutes Walking Test (time frame: baseline,3 months,6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06580340, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.