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Clinical Trials/NCT07043569
NCT07043569RecruitingNot Applicable

Clinical-randomized Trial of the Effect of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Anterior Cruciate Ligament Reconstruction

University Hospital, Bonn1 site in 1 country30 target enrollmentStarted: June 20, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Muscle Strength (N)

Study Overview

Brief Summary

With the intention of improving rehabilitation after anterior cruciate ligament reconstruction, the present project investigates the influence of a targeted strength and blood flow restriction training intervention (BFR training) on the regeneration of muscle mass, strength and functionality of the knee joint. BFR training is characterized by the combination of external venous vascular occlusion with light strength training and still enables users to achieve gains in muscle mass and strength that are comparable to training with high mechanical loads. The positive effects of BFR training in the course of knee arthroplasty have already been demonstrated by our working group as a prehabilitative approach, i.e. as a training intervention prior to surgery. In the present project, the framework conditions of outpatient rehabilitation at the Bonn Center for Outpatient Rehabilitation will now be used to prove whether sports science-controlled strength and BFR training has a similar effect in the postoperative rehabilitation phase. The interventions are carried out as part of the exercise therapy units in outpatient rehabilitation ETM01 in accordance with the S2k guideline on anterior cruciate ligament rupture. Strength and BFR training in medical training therapy supplements the daily exercise therapy to ensure implementation in the rehabilitation process in line with the guidelines.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •ACL reconstruction
  • •Ability to take part in an outpatient rehabilitation

Exclusion Criteria

  • •Sickle Cell anemia
  • •iatrogenic changes in the vessels of the lower limbs (stents, bypasses)
  • •inflammation of the lower extremities

Arms & Interventions

Control Group

Active Comparator

Control group will perform the exercise protocols with a sham-BFR pressure of 20 mmHg.

Intervention: Resistance Training with Sham-BFR (Other)

Intervention Group

Experimental

Intervention group will perform the exercise protocols with a BFR pressure corresponding to 60% of the individual limb occlusion pressure.

Intervention: Resistance Exercise with BFR (Other)

Outcomes

Primary Outcomes

Muscle Strength (N)

Time Frame: Pre- (before Rehabilitation) to Post-Rehabilitation (immediately after three weeks of exercise intervention up to 1 year follow up)

isoemtric maximal strength of both legs will assessed on a isokinetic leg press.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Bonn
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexander Franz

Dr. med., B.Sc.

University Hospital, Bonn

Study Sites (1)

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