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Resistance Training With Blood Flow Restriction in Hemophilia (HemoBFR)

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ClinicalTrials.gov Identifier: NCT05568524
Recruitment Status : Not yet recruiting
First Posted : October 5, 2022
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Sofia Perez-Alenda, University of Valencia

Study Description
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Brief Summary:
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 shoulder abductions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.

Condition or disease Intervention/treatment Phase
Hemophilia Other: BFRT Other: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Acute and Chronic Impact of Blood Flow Restriction Resistance Training on Physical and Neuromuscular Function, Pain, and Quality of Life in Patients With Moderate/Severe Hemophilia
Estimated Study Start Date : March 1, 2023
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
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.
 Other: Control
Moderate-to-high load (60%-80% 1RM) resistance exercise
Experimental: BFRT
The BFR training program for the intervention group consists of elbow flexion and extension, and shoulder abduction exercises performed with low load (elastic bands; equivalent to 30% 1RM) and concurrent BFR at 40% 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.
 Other: BFRT
Low-load (30% 1RM) resistance exercise with blood flow restriction


Outcome Measures
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Primary Outcome Measures :
  1. HDsEMG [ Time Frame: Baseline and week 8. ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  2. Hand-held dynamometry (isometric elbow flexion/extension, shoulder abduction) [ Time Frame: Baseline and week 8. ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  3. Muscle ultrasound (muscle mass, quality; assessment of possible bleedings) [ Time Frame: Baseline and week 8. ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  4. Digital goniometry for active elbow ROM [ Time Frame: Baseline and week 8. ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.


Secondary Outcome Measures :
  1. Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10) [ Time Frame: Baseline and week 8. ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  2. Pressure pain thresholds (digital algometry) [ Time Frame: Baseline and week 8. ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  3. Hand dynamometry (handgrip strength) [ Time Frame: Baseline and week 8. ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  4. Haemophilia Activities List (HAL) questionnaire [ Time Frame: Baseline and week 8. ]

    The HAL measures the impact of hemophilia on self-perceived functional abilities in adults.

    Its score range is 42-252, with higher scores representing more functional limitations.


  5. A36 haemophilia quality of life (Hemofilia-QoL) questionnaire [ Time Frame: Baseline and week 8. ]
    A36 Hemofilia-QOL is a standardized disease specific questionnaire for the assessment of the health-related quality of life of people with haemophilia. The domains are physical health, daily activities, treatment satisfaction, mental aspects, relationships and social activities. There are 36 items and its score range is 0-144, with higher scores representing better outcomes.

  6. Patient Global Impression of Change Scale (PGICS) [ Time Frame: Baseline and week 8. ]
    On this scale, the patient reflects the perception of the efficacy of the treatment received in their limitation to perform activities, symptoms, emotions and overall quality of life. The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1. Meanwhile, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568524


Contacts
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Contact: Sofía Pérez Alenda +34655382100 sofia.perez-alenda@uv.es
Contact: Joaquín Calatayud +34625577509 joaquin.calatayud@uv.es

Sponsors and Collaborators
University of Valencia
Investigators
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Principal Investigator: Sofía Pérez Alenda University of Valencia
Study Chair: Joaquín Calatayud University of Valencia
More Information
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Responsible Party: Sofia Perez-Alenda, Dean of Faculty of Physiotherapy, University of Valencia
ClinicalTrials.gov Identifier: NCT05568524    
Other Study ID Numbers: Hemo-BFR-22-24
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sofia Perez-Alenda, University of Valencia:
Hemophilia
Electromyography
Muscle Activity
Resistance Training
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn