HaemophiliaNCT02781233
A Progressive Resistance Training Program in Patients With Haemophilia
A study testing Progressive resistance training and Normal daily activities in people with Haemophilia, run by University of Valencia at 1 site in Spain.
Trial summary
This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Haemophilia
- What is being tested?
- Progressive resistance training and Normal daily activities
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 24 Oct 2017to 25 Jun 2018
- 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 haemophilia A or B
- 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 6 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, including rehabilitation, during the study; (5) changes in medication during the study
- a major bleeding episode that posed a risk or prevented exercise
- History of FVIII inhibitor (titer ≥ 0.6 BU [Bethesda unit]) or detectable FVIII inhibitors at screening (titer ≥ 0.4 BU)
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- Another haemostatic defect
- Need for major surgery
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia
Read the detailed description
The training program aims improving muscular strength and endurance in the relevant muscles and joints (knee, elbow, ankle, shoulder and hip) in order to improve the quality of life in the patients.
- Conditions
- Haemophilia
- Being tested
- Progressive resistance training, Normal daily activities
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingOther
Progressive resistance training program
Normal daily activitiesOther
Usual daily activities
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions. Receives: Other: Progressive resistance training |
| Control group | Placebo comparator | Usual daily activities Receives: Other: Normal daily activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle strength
For measuring the isometric knee flexion and extension, ankle plantarflexion and dorsiflexion strength and isometric elbow flexion and extension strength, a portable hand-held dynamometer will be used (Nicholas Manual Muscle Tester, Lafayette Instruments, Indiana, USA).
Measured: baseline and 8 weeks
Secondary outcomes (12)
Change in Timed Up and Go
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: baseline and 8 weeks
Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )
The Haemophilia-QoL questionnaire is a self-report modular instrument that assesses nine relevant HRQoL domains for patients with haemophilia (e.g. physical health, daily activities, joint damage, pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health, relationships and social activity).
Measured: baseline and 8 weeks
Change in Bleedings
Number of Bleedings During the study
Measured: daily (during the 8 weeks of intervention)
Change in viscoelastic properties (rectus femoris)
Myoton Pro
Measured: baseline and 8 weeks
Change in sit-to-stand test
The time taken for the participant to stand up and sit down from a standard 45 cm chair with arms three times, as quickly as possible, was measured.
Measured: baseline and 8 weeks
Change in Haemophilia Activities List questionnaire
The Haemophilia Activities List questionnaire measures the impact of hemophilia on self-perceived functional abilities in adults.
It contains 42 multiple choice questions in seven domains:
Lying/sitting/kneeling/standing (8 items) Functions of the legs (9 items) Functions of the arms (4 items) Use of transportation (3 items) Self-care (5 items) Household tasks (6 items) Leisure activities and sports (7 items) The most important outcomes are the overall sum score and three component scores relating to upper extremity activities, basic lower extremity activities, and complex lower extremity activities. A domain score for each of the seven domains can also be calculated.
Measured: baseline and 8 weeks
Change in The Haemophilia Joint Health Score (HJHS)
The HJHS measures joint health, in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in hemophilia: the knees, ankles, and elbows.The HJHS 2.1 provides a total score (higher score is worse; max=124), joint specific scores, and a global gait score.
Measured: baseline and 8 weeks
Change in Pain
11-point numerical pain rating scale with higher score meaning higher pain
Measured: baseline and 8 weeks
Change in workability index
workability index with single question
Measured: baseline and 8 weeks
Change in analgesics use (days/week)
The number of days the participants used analgesics during the last week
Measured: baseline and 8 weeks
Change in Range Of Motion (ROM)
elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer
Measured: baseline and 8 weeks
Change in Kinesiophobia
Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start24 Oct 2017
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HaemophiliaStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Felipe Querol Fuentes, University of Valencia
- Investigators
- Felipe Querol-Fuentes, MD, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781233
- Sponsor's protocol ID
- H15-29504
- Status last verified
- Oct 2018
- First submitted
- 18 May 2016
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calatayud J, Perez-Alenda S, Carrasco JJ, Cruz-Montecinos C, Andersen LL, Bonanad S, Querol F, Megias-Vericat JE, Casana J. Safety and Effectiveness of Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training on Physical Function and Pain in People With Hemophilia. Phys Ther. 2020 Aug 31;100(9):1632-1644. doi: 10.1093/ptj/pzaa106.
PubMed 32525975
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
- ClinicalTrials.gov ID
- NCT02781233
- Acronym / sponsor ID
- H15-29504
- Conditions
- Haemophilia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Shire
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- 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.
This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia
Detailed description
The training program aims improving muscular strength and endurance in the relevant muscles and joints (knee, elbow, ankle, shoulder and hip) in order to improve the quality of life in the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Progressive resistance trainingEach subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions. |
| Control group | Placebo comparator | Other: Normal daily activitiesUsual daily activities |
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 haemophilia A or B
- 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 (9 listed)
- the inability to attend exercise sessions at least twice a week for 6 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, including rehabilitation, during the study; (5) 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 |
|---|---|---|
| Progressive resistance trainingProgressive resistance training program | Other | Training group |
| Normal daily activitiesUsual daily activities | Other | Control group |
Primary outcome
Change in Muscle strength
Time frame: baseline and 8 weeks
For measuring the isometric knee flexion and extension, ankle plantarflexion and dorsiflexion strength and isometric elbow flexion and extension strength, a portable hand-held dynamometer will be used (Nicholas Manual Muscle Tester, Lafayette Instruments, Indiana, USA).
12 secondary outcomes
Change in Timed Up and Go
Time frame: baseline and 8 weeks
Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )
Time frame: baseline and 8 weeks
Change in Bleedings
Time frame: daily (during the 8 weeks of intervention)
Change in viscoelastic properties (rectus femoris)
Time frame: baseline and 8 weeks
Change in sit-to-stand test
Time frame: baseline and 8 weeks
Change in Haemophilia Activities List questionnaire
Time frame: baseline and 8 weeks
Change in The Haemophilia Joint Health Score (HJHS)
Time frame: baseline and 8 weeks
Change in Pain
Time frame: baseline and 8 weeks
Change in workability index
Time frame: baseline and 8 weeks
Change in analgesics use (days/week)
Time frame: baseline and 8 weeks
Change in Range Of Motion (ROM)
Time frame: baseline and 8 weeks
Change in Kinesiophobia
Time frame: baseline and 8 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 18 Oct 2018.
- Derived from this study: PubMed 32525975Calatayud J, Perez-Alenda S, Carrasco JJ, Cruz-Montecinos C, Andersen LL, Bonanad S, Querol F, Megias-Vericat JE, Casana J. Safety and Effectiveness of Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training on Physical Function and Pain in People With Hemophilia. Phys Ther. 2020 Aug 31;100(9):1632-1644. doi: 10.1093/ptj/pzaa106.
- 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.
Felipe Querol-Fuentes, MD, PhD principal investigator
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 Progressive resistance training and Normal daily activities in people with Haemophilia, 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 9 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 18 Oct 2018. 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. Some participants in this study may receive a placebo. 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?
Change in Muscle strength (time frame: baseline and 8 weeks). 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 NCT02781233, which also lists 1 linked publication.
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 18 Oct 2018.