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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

Tracking Information
First Submitted Date  ICMJE September 29, 2022
First Posted Date  ICMJE October 5, 2022
Last Update Posted Date December 16, 2022
Estimated Study Start Date  ICMJE March 1, 2023
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistance Training With Blood Flow Restriction in Hemophilia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia
Intervention  ICMJE
  • Other: BFRT
    Low-load (30% 1RM) resistance exercise with blood flow restriction
  • Other: Control
    Moderate-to-high load (60%-80% 1RM) resistance exercise
Study Arms  ICMJE
  • 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.
    Intervention: Other: Control
  • 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.
    Intervention: Other: BFRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2022)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sofía Pérez Alenda +34655382100 sofia.perez-alenda@uv.es
Contact: Joaquín Calatayud +34625577509 joaquin.calatayud@uv.es
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05568524
Other Study ID Numbers  ICMJE Hemo-BFR-22-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sofia Perez-Alenda, University of Valencia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Valencia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sofía Pérez Alenda University of Valencia
Study Chair: Joaquín Calatayud University of Valencia
PRS Account University of Valencia
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP