A Progressive Resistance Training Program in Patients With Haemophilia

NCT ID: NCT02781233

Last Updated: 2018-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-24

Study Completion Date

2018-06-25

Brief Summary

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This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia

Detailed Description

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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

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Haemophilia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Training group

Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions.

Group Type EXPERIMENTAL

Progressive resistance training

Intervention Type OTHER

Progressive resistance training program

Control group

Usual daily activities

Group Type PLACEBO_COMPARATOR

Normal daily activities

Intervention Type OTHER

Usual daily activities

Interventions

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Progressive resistance training

Progressive resistance training program

Intervention Type OTHER

Normal daily activities

Usual daily activities

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
* Another haemostatic defect
* Need for major surgery
* Withdrawal of informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Felipe Querol Fuentes

Medical doctor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felipe Querol-Fuentes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

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University of Valencia

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 32525975 (View on PubMed)

Other Identifiers

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H15-29504

Identifier Type: -

Identifier Source: org_study_id

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