HemophiliaDOLPHIN-IINCT05895032
Trial of an Exercise Intervention for Children With Haemophilia
A study testing Exercise in people with Hemophilia and Child, Only, run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
"Being able to participate in games and activities with their friends" is one of the things that matters most to boys with haemophilia. At present, there is a lack of robust evidence to determine whether muscle strengthening exercise can improve or negatively affect outcomes for young children with haemophilia. Read more about this study
- Who is it for?
- Ages 6 to 12 years, men only
- Conditions the study is for
- Hemophilia, Child, Only, Musculoskeletal Diseases or Conditions
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2021to 30 Jun 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 6 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12 years, with severe or moderate haemophilia A or B
Who cannot join
- von Willebrand disease
- past history of fracture or trauma to the lower limb
- orthopaedic surgery
- acquired brain injury or any other disturbance of the central nervous system; joint or muscle bleed in the lower limb in the past 6 weeks
- presence of lower limb pain or unable to fully comply with verbal instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development Of a haemophiLia PHysiotherapy INtervention for Optimum Musculoskeletal Health in Children (DOLPHIN-II) - a Randomised Controlled Trial
"Being able to participate in games and activities with their friends" is one of the things that matters most to boys with haemophilia. At present, there is a lack of robust evidence to determine whether muscle strengthening exercise can improve or negatively affect outcomes for young children with haemophilia. With the help of boys with haemophilia, their parents and physiotherapists the investigators have developed an exercise programme designed to increase muscle strength. Using this intervention the investigators will undertake a single-blinded, two-arm pragmatic randomised controlled trial (RCT) of a 12-week intervention verses usual care of boys with haemophilia aged 6-12 years of age.
Read the detailed description
Children are born with haemophilia. Females carry the disorder and usually males are affected. It is a disorder affecting 1:10000 people where the blood does not clot normally, leading to bleeding into muscles and joints. As a result, muscles become weak. Joints become painful and difficult to move. "Being able to participate in games and activities with their friends" is one of the things that matters most to boys with haemophilia. "What is the role of exercise for both prevention and treatment of joint damage in haemophilia?" is one of the top unanswered questions that concern patients, carers and healthcare professionals most. At present, there is a lack of robust evidence to determine whether muscle strengthening exercise can improve or negatively affect outcomes for young children with haemophilia. With the help of boys with haemophilia, their parents and physiotherapists the investigators have developed an exercise programme designed to increase muscle strength. The investigators think the exercise programme might have an effect on pain and movement in participants joints, help them participate in games and activities with their friends and improve their health in the long term. The investigators recently showed the exercise programme had no harmful effects, was acceptable to children with haemophilia and that the participants were willing to participate in a study to answer the question, "does muscle strengthening help improve the long term health of children with haemophilia?" To answer this question, the investigators will allocate 66 boys with haemophilia to a group that is asked to complete the 12-week exercise routine to strengthen their leg muscles and another 66 boys to a group that does not do the exercises. The boys will be allocated at random, so that each boy has an equal chance of being in either group. Random allocation helps ensure that two similar groups of boys will be compared. The investigators will monitor the boys throughout the study by measuring their muscle strength, how far they can walk in six-minutes and time taken to ascend and descend 12 steps. The investigators will also record how physically active the boys are using a wrist band as well as how satisfied they are with their health. The study will be managed by a group of health care professionals and researchers with experience and expertise in carrying out this type of research. In addition, the investigators will include parents of boys with haemophilia in the research team to provide invaluable lived experience of living with the condition. So that people hear about what the investigators learn in the study, the investigators will report the findings to other researchers using journals, relevant health care professionals through face to face meetings, and children with haemophilia and their families through newsletters and presentations at Haemophilia Society meetings.
- Being tested
- Exercise, Usual Care
- Keywords
- Physical Therapy, Exercise, Muscle strength
- Medical subject headings
- Hemophilia A, Musculoskeletal Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
12-week exercise intervention
Usual CareOther
usual care
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 12-week exercise intervention Receives: Other: Exercise |
| Usual care | Active comparator | Participants will continue to receive their usual care as prescribed by the haematologist, physiotherapist and other members of the healthcare team. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength of the dominant knee extensors at 24 weeks
Maximum isometric torque (Newton.metres/kilogram of body weight)
Measured: 24-weeks
Secondary outcomes (6)
Muscle strength of the ankle plantarflexors and non-dominant knee extensors at 24 weeks
maximum isometric torque (Newton.metres/kilogram of body weight)
Measured: 24 weeks
Bleeding episodes and coagulation factor usage
Number of bleeding episodes (number) and amount of coagulation factor used for treatment (number)
Measured: 24 weeks
Six-minute timed walk (6MTW)
Distance walked in 6 minutes (metres)
Measured: 24 weeks
Timed up and down stairs (TUDS)
Time taken to ascend and descend a flight of 12 steps (seconds)
Measured: 24 weeks
Participation in physical activity
Time spent in moderate-vigorous physical activity physical activity (MVPA)
Measured: 24 weeks
Child Health Utility 9D (CHU9D)
a paediatric preference based measure of health related quality of life (utility values on the 0.0 to 1.0 quality adjusted life year scale) Higher score represent higher adjusted life years.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start6 May 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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
- Model description
- A single-blinded, two-arm pragmatic randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Kent Hospitals University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, University of Kent
- Responsible party
- Sponsor
- Investigators
- David Stephensen, PhD, Study chair, East Kent Hospitals University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895032
- Sponsor's protocol ID
- 2020/HAEMO/01
- Acronym
- DOLPHIN-II
- Status last verified
- Aug 2024
- First submitted
- 21 Jul 2020
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have consent to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Of a haemophiLia PHysiotherapy INtervention for Optimum Musculoskeletal Health in Children (DOLPHIN-II) - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05895032
- Acronym / sponsor ID
- DOLPHIN-II / 2020/HAEMO/01
- Keywords
- Physical Therapy, Exercise, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- East Kent Hospitals University NHS Foundation TrustOther government
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, University of Kent
- Study start
- 6 May 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 Jun 2023 (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.
"Being able to participate in games and activities with their friends" is one of the things that matters most to boys with haemophilia. At present, there is a lack of robust evidence to determine whether muscle strengthening exercise can improve or negatively affect outcomes for young children with haemophilia. With the help of boys with haemophilia, their parents and physiotherapists the investigators have developed an exercise programme designed to increase muscle strength. Using this intervention the investigators will undertake a single-blinded, two-arm pragmatic randomised controlled trial (RCT) of a 12-week intervention verses usual care of boys with haemophilia aged 6-12 years of age.
Detailed description
Children are born with haemophilia. Females carry the disorder and usually males are affected. It is a disorder affecting 1:10000 people where the blood does not clot normally, leading to bleeding into muscles and joints. As a result, muscles become weak. Joints become painful and difficult to move. "Being able to participate in games and activities with their friends" is one of the things that matters most to boys with haemophilia. "What is the role of exercise for both prevention and treatment of joint damage in haemophilia?" is one of the top unanswered questions that concern patients, carers and healthcare professionals most. At present, there is a lack of robust evidence to determine whether muscle strengthening exercise can improve or negatively affect outcomes for young children with haemophilia. With the help of boys with haemophilia, their parents and physiotherapists the investigators have developed an exercise programme designed to increase muscle strength. The investigators think the exercise programme might have an effect on pain and movement in participants joints, help them participate in games and activities with their friends and improve their health in the long term. The investigators recently showed the exercise programme had no harmful effects, was acceptable to children with haemophilia and that the participants were willing to participate in a study to answer the question, "does muscle strengthening help improve the long term health of children with haemophilia?" To answer this question, the investigators will allocate 66 boys with haemophilia to a group that is asked to complete the 12-week exercise routine to strengthen their leg muscles and another 66 boys to a group that does not do the exercises. The boys will be allocated at random, so that each boy has an equal chance of being in either group. Random allocation helps ensure that two similar groups of boys will be compared. The investigators will monitor the boys throughout the study by measuring their muscle strength, how far they can walk in six-minutes and time taken to ascend and descend 12 steps. The investigators will also record how physically active the boys are using a wrist band as well as how satisfied they are with their health. The study will be managed by a group of health care professionals and researchers with experience and expertise in carrying out this type of research. In addition, the investigators will include parents of boys with haemophilia in the research team to provide invaluable lived experience of living with the condition. So that people hear about what the investigators learn in the study, the investigators will report the findings to other researchers using journals, relevant health care professionals through face to face meetings, and children with haemophilia and their families through newsletters and presentations at Haemophilia Society meetings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blinded, two-arm pragmatic randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise12-week exercise intervention |
| Usual care | Active comparator | Other: Usual CareParticipants will continue to receive their usual care as prescribed by the haematologist, physiotherapist and other members of the healthcare team. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6-12 years, with severe or moderate haemophilia A or B
Key exclusion criteria (5 listed)
- von Willebrand disease
- past history of fracture or trauma to the lower limb
- orthopaedic surgery
- acquired brain injury or any other disturbance of the central nervous system; joint or muscle bleed in the lower limb in the past 6 weeks
- presence of lower limb pain or unable to fully comply with verbal instructions.
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 |
|---|---|---|
| Exercise12-week exercise intervention | Other | Exercise |
| Usual Careusual care | Other | Usual care |
Primary outcome
Muscle strength of the dominant knee extensors at 24 weeks
Time frame: 24-weeks
Maximum isometric torque (Newton.metres/kilogram of body weight)
6 secondary outcomes
Muscle strength of the ankle plantarflexors and non-dominant knee extensors at 24 weeks
Time frame: 24 weeks
Bleeding episodes and coagulation factor usage
Time frame: 24 weeks
Six-minute timed walk (6MTW)
Time frame: 24 weeks
Timed up and down stairs (TUDS)
Time frame: 24 weeks
Participation in physical activity
Time frame: 24 weeks
Child Health Utility 9D (CHU9D)
Time frame: 24 weeks
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 10 Sep 2026.
- Individual participant dataSharing planned: No. We do not have consent to share individual participant data
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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.
David Stephensen, PhD study chair
East Kent Hospitals University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hemophilia and Child, Only, run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 5 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 10 Sep 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 United Kingdom. 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?
Muscle strength of the dominant knee extensors at 24 weeks (time frame: 24-weeks). 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 Sep 2026.