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

NCT07043569 | Recruiting

• 1 other identifier: 2024_F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL - Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• Muscle Strength (N)

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

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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Resistance Training with Sham-BFR

Intervention Group

EXPERIMENTAL

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

Other: Resistance Exercise with BFR

Interventions

Resistance Training with Sham-BFR OTHER

The exercise protocol provides for units of approx. 25 minutes of BFR training five times a week as part of medical training therapy. Based on the initial strength measurements prior to rehabilitation, the training phase of the intervention group starts with 30% of the 1RM (calculated from the force-velocity profile) and 70% LOP in the operated leg and 75% of the 1RM (calculated from the force-velocity profile) in the unoperated leg. The patients are randomized into 2 groups: 1) intervention group, which receives a daily intervention with an occlusion pressure and the 2) control group, which receives a daily "Sham-BFR" intervention with an occlusion pressure of 20mmHg.

Control Group

Resistance Exercise with BFR OTHER

The exercise protocol provides for units of approx. 25 minutes of BFR training five times a week as part of medical training therapy. Based on the initial strength measurements prior to rehabilitation, the training phase of the intervention group starts with 30% of the 1RM (calculated from the force-velocity profile) and 70% LOP in the operated leg and 75% of the 1RM (calculated from the force-velocity profile) in the unoperated leg. The patients are randomized into 2 groups: 1) intervention group, which receives a daily intervention with an occlusion pressure and the 2) control group, which receives a daily "Sham-BFR" intervention with an occlusion pressure of 20mmHg.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Alexander Franz, Dr. med., B.Sc.

CONTACT

+491703750718; alexander.franz@ukbonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., B.Sc.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)