HemophiliaHemofisioNCT04114448
Therapeutic Exercise in Patients With Hemophilia
A study testing Therapeutic exercise and Usual physical therapy care in people with Hemophilia, run by University of Seville at 1 site in Spain.
Trial summary
Objectives: To assess the efficacy of performing a therapeutic exercise program, compared with usual care, on pain relief, range of movement and self-perceived quality of life in patients with hemophilia Design: Quantitative, experimental, longitudinal and prospective study. Read more about this study
- Who is it for?
- Ages 30 to 45 years, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Therapeutic exercise and Usual physical therapy care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 1 Apr 2023
- 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 30 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of hemophilia type A or hemophilia type B.
- Knee, elbow or ankle arthropathy caused by hemophilia
- Pharmacological treatment based on using VIII or IX factor concentrates.
Who cannot join
- Presence of VIII FIX inhibitors.
- Having received anti-inflammatory treatment using Arcoxia (Etoricoxib)
- Having undergone a surgical intervention at the target joint.
- Patients enrolled in other research which implies doing physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Exercise: Does it Improve Pain Perception, Range of Movement and Quality of Life in Patients With Hemophilia
Objectives: To assess the efficacy of performing a therapeutic exercise program, compared with usual care, on pain relief, range of movement and self-perceived quality of life in patients with hemophilia
Design: Quantitative, experimental, longitudinal and prospective study.
Read more
Subjects: Male patients between 30 and 45 years old, with hemophilia type A or B and with knee, ankle or elbow arthropathy caused by hemophilia. Participants may be undergoing a pharmacologic treatment with intravenous VIII and/or IX factor
Methods: Participants in the experimental group will an intervention based on therapeutic exercise. One therapist will instruct the patients during two sessions (each lasting approximately 1 hour). Participants will be asked to continue this program at least twice a week. Meanwhile, those in the control group will receive usual physical therapy care, based on a more passive approach, including self-assisted joint mobilization and muscle stretching. Those in the control group will be also instructed to perform the protocol at home, at least twice a week. The intervention protocol in both groups will last three months
- Conditions
- Hemophilia
- Being tested
- Therapeutic exercise, Usual physical therapy care
- Keywords
- Hemophilia, Therapeutic exercise, Physical therapy, Randomized controlled trial, Pain perception, Range of movement
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
Patients will perform an exercise protocol specifically designed for patients with hemophilia that will include exercises focused on improving range of movement, strength, flexibility, balance and coordination as well as diaphragmatic breathing at the start and at the beginning of each session.
Usual physical therapy careOther
Patients will undergo usual physical therapy treatment for hemophiliacs, based on affected self and gentle joint mobilization and stretching of muscles involved in the affected joints.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise | Experimental | Patients will be trained to perform a therapeutic exercise intervention protocol. The program will be based on active physical activity including strength, balance an coordination exercises, among others. Each initial contact session will last approximately 1 hour. After baseline, participants will be instructed to undergo at least two sessions per week during 3 consecutive months. Receives: Other: Therapeutic exercise |
| Usual care | Active comparator | Patients will be instructed to perform an usual care physical therapy intervention protocol. Participants in this group will be told to undergo gentle self-performed joint mobilization and stretching exercises. Each initial contact session will last approximately 1 hour. After baseline, participants will be instructed to undergo at least two sessions per week during 3 consecutive months. Receives: Other: Usual physical therapy care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold (PPT) in the evaluated muscles.
The PPT levels will be evaluated in KPa. PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
Measured: Change from baseline to 3 months after intervention
Self-reported pain intensity: Numeric Pain Rating Scale (NPRS)
Self-reported pain will be evaluated using the Numeric Pain Rating Scale (NPRS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain.
Measured: Change from baseline to 3 months after intervention
Range of movement (ROM).
Active ROM of the affected joint will be evaluated using inertial sensors, that measure lineal acceleration and angular velocity.
Measured: Change from baseline to 3 months after intervention
General flexibility
General flexibility will be assessed using the improved tot-flex test, which makes possible to extrapolate general flexibility from a combined movement measure.
Measured: Change from baseline to 3 months after intervention
Daily life activities
Ordinary daily life activities will be assessed using the Haemophilia Activities List, which measures the self-perceived functional state.
Measured: Change from baseline to 3 months after intervention
Self-perceived quality of life: A36 Haemophilia-QoL test
Quality of life will be evaluated using the A36 Haemophilia-QoL test. This is a valid and specific tool for hemophiliac adults.
Measured: Change from baseline to 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Apr 2021
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Why it stopped: The Study was terminated due to lack of funding for continuing
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Marcos Heredia-Rizo, University of Seville
- Investigators
- Alberto M Heredia-Rizo, PhD, Principal investigator, Physiotherapy Department, University of Sevilla, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114448
- Sponsor's protocol ID
- HemoFisio2020
- Acronym
- Hemofisio
- Status last verified
- May 2022
- First submitted
- 27 Sep 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Exercise: Does it Improve Pain Perception, Range of Movement and Quality of Life in Patients With Hemophilia
- ClinicalTrials.gov ID
- NCT04114448
- Acronym / sponsor ID
- Hemofisio / HemoFisio2020
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Therapeutic exercise, Physical therapy, Randomized controlled trial, Pain perception, Range of movement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Study was terminated due to lack of funding for continuing
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 3 Oct 2019 (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.
Objectives: To assess the efficacy of performing a therapeutic exercise program, compared with usual care, on pain relief, range of movement and self-perceived quality of life in patients with hemophilia
Design: Quantitative, experimental, longitudinal and prospective study.
Subjects: Male patients between 30 and 45 years old, with hemophilia type A or B and with knee, ankle or elbow arthropathy caused by hemophilia. Participants may be undergoing a pharmacologic treatment with intravenous VIII and/or IX factor
Methods: Participants in the experimental group will an intervention based on therapeutic exercise. One therapist will instruct the patients during two sessions (each lasting approximately 1 hour). Participants will be asked to continue this program at least twice a week. Meanwhile, those in the control group will receive usual physical therapy care, based on a more passive approach, including self-assisted joint mobilization and muscle stretching. Those in the control group will be also instructed to perform the protocol at home, at least twice a week. The intervention protocol in both groups will last three months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise | Experimental | Other: Therapeutic exercisePatients will be trained to perform a therapeutic exercise intervention protocol. The program will be based on active physical activity including strength, balance an coordination exercises, among others. Each initial contact session will last approximately 1 hour. After baseline, participants will be instructed to undergo at least two sessions per week during 3 consecutive months. |
| Usual care | Active comparator | Other: Usual physical therapy carePatients will be instructed to perform an usual care physical therapy intervention protocol. Participants in this group will be told to undergo gentle self-performed joint mobilization and stretching exercises. Each initial contact session will last approximately 1 hour. After baseline, participants will be instructed to undergo at least two sessions per week during 3 consecutive months. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of hemophilia type A or hemophilia type B.
- Knee, elbow or ankle arthropathy caused by hemophilia
- Pharmacological treatment based on using VIII or IX factor concentrates.
Key exclusion criteria (4 listed)
- Presence of VIII FIX inhibitors.
- Having received anti-inflammatory treatment using Arcoxia (Etoricoxib)
- Having undergone a surgical intervention at the target joint.
- Patients enrolled in other research which implies doing physical 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 |
|---|---|---|
| Therapeutic exercisePatients will perform an exercise protocol specifically designed for patients with hemophilia that will include exercises focused on improving range of movement, strength, flexibility, balance and coordination as well as diaphragmatic breathing at the start and at the beginning of each session. | Other | Therapeutic exercise |
| Usual physical therapy carePatients will undergo usual physical therapy treatment for hemophiliacs, based on affected self and gentle joint mobilization and stretching of muscles involved in the affected joints. | Other | Usual care |
Primary outcome
Pressure pain threshold (PPT) in the evaluated muscles.
Time frame: Change from baseline to 3 months after intervention
The PPT levels will be evaluated in KPa. PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
Self-reported pain intensity: Numeric Pain Rating Scale (NPRS)
Time frame: Change from baseline to 3 months after intervention
Self-reported pain will be evaluated using the Numeric Pain Rating Scale (NPRS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain.
Range of movement (ROM).
Time frame: Change from baseline to 3 months after intervention
Active ROM of the affected joint will be evaluated using inertial sensors, that measure lineal acceleration and angular velocity.
General flexibility
Time frame: Change from baseline to 3 months after intervention
General flexibility will be assessed using the improved tot-flex test, which makes possible to extrapolate general flexibility from a combined movement measure.
Daily life activities
Time frame: Change from baseline to 3 months after intervention
Ordinary daily life activities will be assessed using the Haemophilia Activities List, which measures the self-perceived functional state.
Self-perceived quality of life: A36 Haemophilia-QoL test
Time frame: Change from baseline to 3 months after intervention
Quality of life will be evaluated using the A36 Haemophilia-QoL test. This is a valid and specific tool for hemophiliac adults.
Results and safety
The study was stopped early (reason given: The Study was terminated due to lack of funding for continuing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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.
Alberto M Heredia-Rizo, PhD principal investigator
Physiotherapy Department, University of Sevilla, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise and Usual physical therapy care in people with Hemophilia, run by University of Seville 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 May 2023. 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 was stopped early (reason given: The Study was terminated due to lack of funding for continuing). Results are not available in the source record.
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?
Pressure pain threshold (PPT) in the evaluated muscles. (time frame: Change from baseline to 3 months after intervention). The study lists 6 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 10 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.