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Resistance Training With Blood Flow Restriction in Hemophilia (HemoBFR)

Primary Purpose

Hemophilia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BFRT
Control
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia focused on measuring Hemophilia, Electromyography, Muscle Activity, Resistance Training

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    BFRT

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    HDsEMG
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Hand-held dynamometry (isometric elbow flexion/extension, shoulder abduction)
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Muscle ultrasound (muscle mass, quality; assessment of possible bleedings)
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Digital goniometry for active elbow ROM
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

    Secondary Outcome Measures

    Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Pressure pain thresholds (digital algometry)
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Hand dynamometry (handgrip strength)
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Haemophilia Activities List (HAL) questionnaire
    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.
    A36 haemophilia quality of life (Hemofilia-QoL) questionnaire
    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.
    Patient Global Impression of Change Scale (PGICS)
    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.

    Full Information

    First Posted
    September 29, 2022
    Last Updated
    December 14, 2022
    Sponsor
    University of Valencia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05568524
    Brief Title
    Resistance Training With Blood Flow Restriction in Hemophilia
    Acronym
    HemoBFR
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    January 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Valencia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemophilia
    Keywords
    Hemophilia, Electromyography, Muscle Activity, Resistance Training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    BFRT
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    BFRT
    Intervention Description
    Low-load (30% 1RM) resistance exercise with blood flow restriction
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Moderate-to-high load (60%-80% 1RM) resistance exercise
    Primary Outcome Measure Information:
    Title
    HDsEMG
    Description
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Time Frame
    Baseline and week 8.
    Title
    Hand-held dynamometry (isometric elbow flexion/extension, shoulder abduction)
    Description
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Time Frame
    Baseline and week 8.
    Title
    Muscle ultrasound (muscle mass, quality; assessment of possible bleedings)
    Description
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Time Frame
    Baseline and week 8.
    Title
    Digital goniometry for active elbow ROM
    Description
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Time Frame
    Baseline and week 8.
    Secondary Outcome Measure Information:
    Title
    Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
    Description
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Time Frame
    Baseline and week 8.
    Title
    Pressure pain thresholds (digital algometry)
    Description
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Time Frame
    Baseline and week 8.
    Title
    Hand dynamometry (handgrip strength)
    Description
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
    Time Frame
    Baseline and week 8.
    Title
    Haemophilia Activities List (HAL) questionnaire
    Description
    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.
    Time Frame
    Baseline and week 8.
    Title
    A36 haemophilia quality of life (Hemofilia-QoL) questionnaire
    Description
    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.
    Time Frame
    Baseline and week 8.
    Title
    Patient Global Impression of Change Scale (PGICS)
    Description
    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.
    Time Frame
    Baseline and week 8.

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sofía Pérez Alenda
    Phone
    +34655382100
    Email
    sofia.perez-alenda@uv.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joaquín Calatayud
    Phone
    +34625577509
    Email
    joaquin.calatayud@uv.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sofía Pérez Alenda
    Organizational Affiliation
    University of Valencia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Joaquín Calatayud
    Organizational Affiliation
    University of Valencia
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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