HemophiliaHemoBFRNCT05568524
Resistance Training With Blood Flow Restriction in Hemophilia
A study testing BFRT in people with Hemophilia, run by University of Valencia at 1 site in Spain.
Trial summary
The main objectives of this study are to evaluate safety and chronic effects of a low-load resistance exercise intervention (elbow flexions and extensions, and knee extensions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- BFRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2024to 30 Jan 2026
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of hemophilia A or B and undergoing prophylaxis;
- willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
- approval by their hematologist to participate in the exercise program;
- age between 18 and 60 years;
- informed consent signed.
Who cannot join
- the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
- non adherence to instruction on proper exercise technique;
- surgical procedures performed 6 weeks prior to or during the exercise program; - participation in any other form of exercise, not previously done, during the study;
- changes in medication during the study;
- a major bleeding episode that posed a risk or prevented exercise;
- another hemostatic defect;
- need for major surgery;
- withdrawal of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute and Chronic Impact of Blood Flow Restriction Resistance Training on Physical and Neuromuscular Function, Pain, and Quality of Life in Patients With Moderate/Severe Hemophilia
The main objectives of this study are to evaluate safety and chronic effects of a low-load resistance exercise intervention (elbow flexions and extensions, and knee extensions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.
- Conditions
- Hemophilia
- Being tested
- BFRT, Control
- Keywords
- Hemophilia, Electromyography, Muscle Activity, Resistance Training
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFRTOther
Low-load (30% 1RM) resistance exercise with blood flow restriction
ControlOther
Moderate-to-high load (60%-80% 1RM) resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The training program for the control group consists of a telerehabilitation with traditional moderate-to-high load (60%-80% 1RM) exercises (the same as the intervention group sans BFR), utilizing elastic bands. This program for the control group will be conducted in an in-home real-time audio and video style and supervised by a physiotherapist. Receives: Other: Control |
| BFRT | Experimental | The BFR training program for the intervention group consists of elbow flexion and extension, and knee extension exercises performed with low load (elastic bands; equivalent to 30% 1RM) and concurrent BFR (upper limb 50% AOP; lower limb 60% AOP). Subjects will perform 4 sets (30, 15, 15 and 15 reps) of each exercise with 30 s rest between sets and 5-minute rest between exercises. Receives: Other: BFRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDsEMG
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Measured: Baseline and week 8.
Hand-held dynamometry (isometric elbow flexion/extension, knee extension)
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Measured: Baseline and week 8.
Muscle ultrasound (muscle mass, assessment of possible bleedings)
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Measured: Baseline and week 8.
Digital goniometry for active elbow and knee ROM
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Measured: Baseline and week 8.
Secondary outcomes (5)
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Measured: Baseline and week 8.
Pressure pain thresholds (digital algometry)
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Measured: Baseline and week 8.
Haemophilia Activities List (HAL) questionnaire
The HAL measures the impact of hemophilia on self-perceived functional abilities in adults.
Its score range is 42-252, with higher scores representing more functional limitations.
Measured: Baseline and week 8.
A36 haemophilia quality of life (Hemofilia-QoL) questionnaire
A36 Hemofilia-QOL is a standardized disease specific questionnaire for the assessment of the health-related quality of life of people with haemophilia. The domains are physical health, daily activities, treatment satisfaction, mental aspects, relationships and social activities. There are 36 items and its score range is 0-144, with higher scores representing better outcomes.
Measured: Baseline and week 8.
Patient Global Impression of Change Scale (PGICS)
On this scale, the patient reflects the perception of the efficacy of the treatment received in their limitation to perform activities, symptoms, emotions and overall quality of life. The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1. Meanwhile, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.
Measured: Baseline and week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start15 Jan 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Perez-Alenda, University of Valencia
- Investigators
- Sofía Pérez Alenda, Principal investigator, University of ValenciaJoaquín Calatayud, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568524
- Sponsor's protocol ID
- Hemo-BFR-22-24
- Acronym
- HemoBFR
- Status last verified
- Jan 2026
- First submitted
- 29 Sep 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute and Chronic Impact of Blood Flow Restriction Resistance Training on Physical and Neuromuscular Function, Pain, and Quality of Life in Patients With Moderate/Severe Hemophilia
- ClinicalTrials.gov ID
- NCT05568524
- Acronym / sponsor ID
- HemoBFR / Hemo-BFR-22-24
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Electromyography, Muscle Activity, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 5 Oct 2022 (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 main objectives of this study are to evaluate safety and chronic effects of a low-load resistance exercise intervention (elbow flexions and extensions, and knee extensions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlThe training program for the control group consists of a telerehabilitation with traditional moderate-to-high load (60%-80% 1RM) exercises (the same as the intervention group sans BFR), utilizing elastic bands. This program for the control group will be conducted in an in-home real-time audio and video style and supervised by a physiotherapist. |
| BFRT | Experimental | Other: BFRTThe BFR training program for the intervention group consists of elbow flexion and extension, and knee extension exercises performed with low load (elastic bands; equivalent to 30% 1RM) and concurrent BFR (upper limb 50% AOP; lower limb 60% AOP). Subjects will perform 4 sets (30, 15, 15 and 15 reps) of each exercise with 30 s rest between sets and 5-minute rest between exercises. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of hemophilia A or B and undergoing prophylaxis;
- willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
- approval by their hematologist to participate in the exercise program;
- age between 18 and 60 years;
- informed consent signed.
Key exclusion criteria (8 listed)
- the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
- non adherence to instruction on proper exercise technique;
- surgical procedures performed 6 weeks prior to or during the exercise program; - participation in any other form of exercise, not previously done, during the study;
- changes in medication during the study;
- a major bleeding episode that posed a risk or prevented exercise;
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 |
|---|---|---|
| BFRTLow-load (30% 1RM) resistance exercise with blood flow restriction | Other | BFRT |
| ControlModerate-to-high load (60%-80% 1RM) resistance exercise | Other | Control |
Primary outcome
HDsEMG
Time frame: Baseline and week 8.
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Hand-held dynamometry (isometric elbow flexion/extension, knee extension)
Time frame: Baseline and week 8.
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Muscle ultrasound (muscle mass, assessment of possible bleedings)
Time frame: Baseline and week 8.
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Digital goniometry for active elbow and knee ROM
Time frame: Baseline and week 8.
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
5 secondary outcomes
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Time frame: Baseline and week 8.
Pressure pain thresholds (digital algometry)
Time frame: Baseline and week 8.
Haemophilia Activities List (HAL) questionnaire
Time frame: Baseline and week 8.
A36 haemophilia quality of life (Hemofilia-QoL) questionnaire
Time frame: Baseline and week 8.
Patient Global Impression of Change Scale (PGICS)
Time frame: Baseline and week 8.
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 3 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Sofía Pérez Alenda principal investigator
University of Valencia
Joaquín Calatayud study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFRT in people with Hemophilia, run by University of Valencia at 1 site in Spain.
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 5 inclusion and 8 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 3 Feb 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 Spain. 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?
HDsEMG (time frame: Baseline and week 8.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.