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
|Condition or disease||Intervention/treatment||Phase|
|Hemophilia||Other: BFRT Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
Moderate-to-high load (60%-80% 1RM) resistance exercise
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.
Low-load (30% 1RM) resistance exercise with blood flow restriction
- 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. ]
- Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10) [ Time Frame: Baseline and week 8. ]
- Pressure pain thresholds (digital algometry) [ Time Frame: Baseline and week 8. ]
- Hand dynamometry (handgrip strength) [ Time Frame: Baseline and week 8. ]
- 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.
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
|Contact: Sofía Pérez Alendafirstname.lastname@example.org|
|Contact: Joaquín Calatayudemail@example.com|
|Principal Investigator:||Sofía Pérez Alenda||University of Valencia|
|Study Chair:||Joaquín Calatayud||University of Valencia|