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Resistance Training With Blood Flow Restriction in Hemophilia (HemoBFR)

U

University of Valencia

Status

Completed

Conditions

Hemophilia

Treatments

Other: Control
Other: BFRT

Study type

Interventional

Funder types

Other

Identifiers

NCT05568524
Hemo-BFR-22-24

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Control
Active Comparator group
Description:
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.
Treatment:
Other: Control
BFRT
Experimental group
Description:
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.
Treatment:
Other: BFRT

Trial contacts and locations

1

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Central trial contact

Joaquín Calatayud; Sofía Pérez Alenda

Data sourced from clinicaltrials.gov

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