The purpose of this study is to evaluate the effect of low-load BFR therapy on quadriceps and hamstring strength 8-, 14-, 26-, 39- and 52-weeks after BPTB ACL reconstruction compared to placebo BFR therapy and conventional HLR training.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes are: quadriceps and hamstring strength 8-, 14-, 26-, 39- and
52-weeks after BPTB ACL reconstruction.
Secondary outcome
Secondary outcomes are leg muscle size, physical function, patient
satisfaction, patient confidence, knee laxity, knee pain and knee effusion 8-,
14-, 26-, 39- and 52-weeks after BPTB ACL reconstruction. Furthermore,
completion of revalidation and adverse events will be documented.
Background summary
Heavy load resistance (HLR) training using external loads of 70% repetition
maximum (RM) is recommended to stimulate muscle hypertrophy and strength.
Low-load blood flow restriction (BFR) therapy using external loads of 30% RM is
becoming increasingly popular in anterior cruciate ligament (ACL) injury
rehabilitation. The advantage of low-load BFR therapy is that strength training
can be started immediately after surgery. However, the effect of low-load BFR
therapy after bone-patellar tendon-bone (BPTB) ACL reconstruction is still
unknown.
Study objective
The purpose of this study is to evaluate the effect of low-load BFR therapy on
quadriceps and hamstring strength 8-, 14-, 26-, 39- and 52-weeks after BPTB ACL
reconstruction compared to placebo BFR therapy and conventional HLR training.
Study design
A prospective randomized placebo-controlled trial.
Study burden and risks
BFR therapy has been suggested to increase the risk of adverse cardiovascular
or cerebrovascular events in diseases such as hypertension, heart failure and
peripheral artery. No other side-effects of BFR therapy have been reported.
dr h vd Hoffplein 1
Sittard-Geleen 6162 BG
NL
dr h vd Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
Patients who underwent primary bone-patellar tendon-bone anterior cruciate
ligament reconstruction
Exclusion criteria
Patients known with
• diabetes
• sickle cell anemia
• severe hypertension
• renal compromise
• venous thromboembolism
• extremity infection
• lymphadenectomy
• cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71800.096.19 |