Effects of Low-intensity Strength Training With Concomitant Blood Flow Restriction on Pain Perception in Patients With Anterior Cruciate Ligament Surgery

NCT ID: NCT06699264

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-21

Brief Summary

After surgical treatment of a tear of the anterior cruciate ligament, physiotherapeutic exercises are done as standard therapy. This is to achieve a rapid improvement in pain and knee function. In this study, the Investigators examine how low-intensity strength training with simultaneous restriction of blood flow works and whether it is effective and well tolerated. For this purpose, a pressure cuff is applied to the leg during training. Participation in this study will last four weeks for each participant. The Investigators will invite participants for 11 study visits. One appointment will last about 30 minutes. If a participant decides to take part in the study, they will be randomly assigned to one of two groups. The participants will belong to either an experimental group or the control group. In the experimental group, the participants will be treated with the intervention method. The intervention method involves 4 weeks of low-intensity strength training with an additional pressure cuff on the leg, which should lead to improved adaptations to the muscle as well as a reduction in pain. In the control group, the participants will receive the same strength training only without the additional pressure cuff. The benefit is that in addition to the participants actual rehabilitation program, each participant will receive free training to build their muscles. This could contribute to an accelerated rehabilitation process and a faster build-up of strength as well as an improvement in pain. It is additionally possible that the participants will help future patients with their participation. The intervention method for strength training with simultaneous restriction of blood flow (Blood Flow Restriction Training) has been studied for some time. There is good evidence of improved muscle, tendon and pain adaptations in both healthy individuals and patients with ACL injury. Whether this training method also has an effect on pain perception will be investigated in this study.

Participants may experience side effects if they are treated with the intervention method (low-intensity strength training with simultaneous restriction of blood flow). The Investigators may not yet know all the risks and side effects of the intervention method. So far, the following risks and side effects are known:

• Temporay numbness
• Muscle soreness
• Pressure sensation

Conditions

Anterior Cruciate Ligament Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Group 1 (experimental group) will be trained with the intervention method (low-load strength training) using the Tourniquet Touch (VBM Medizintechnik GmbH Einsteinstrasse 1, 72172 Sulz a.N., Germany)

Group Type: EXPERIMENTAL

Blood Flow Restriction Training

Intervention Type: OTHER

Pressure cuff is applied to the leg during training for low-load strength training with simultaneous restiction of blood flow

Control Group

Group 2 (controll group) receives the same strength training only without simultaneous restriction blood flow.

Group Type: ACTIVE_COMPARATOR

Training without BFR

Intervention Type: OTHER

Strength training according to experimentral group without simultaneous restriction blood flow

Interventions

Blood Flow Restriction Training

Pressure cuff is applied to the leg during training for low-load strength training with simultaneous restiction of blood flow

Intervention Type: OTHER

Training without BFR

Strength training according to experimentral group without simultaneous restriction blood flow

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• It must be your first anterior cruciate ligament surgery
• You must be between 18 and 60 years old
• You must be able to successfully complete certain exercises
• The injury must have occurred no longer than 6 months ago

Exclusion Criteria

• Injury in other ligaments in the knee and cartilage
• thrombosis
• infection
• high blood pressure (which is not treated with medication)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Praxisklinik Rennbahn AG

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Praxisklinik Rennbahn AG

Muttenz, Basel, Switzerland

Countries

Switzerland

Other Identifiers

Forschungsförderung Nr. 106

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-00151

Identifier Type: -

Identifier Source: org_study_id