Impact of Blood-Flow-Restriction Prehabilitation on Pre- and Postoperative Rehabilitation After Total Knee Arthroplasty

NCT ID: NCT06964022

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-02-01

Brief Summary

Degenerative and traumatic diseases of the musculoskeletal system lead to increased immobility of a patient, which in turn results in muscle atrophy. BFR training is a training method in which a blood pressure cuff partially blocks the arterial blood flow to the exercising limb and completely blocks the venous blood flow. During exercise, an externally induced venous occlusion occurs. This stimulus increases the metabolic stimulus in the occluded extremity - this means that strength can be increased even with low weights, which is why this training is also suitable for people who should not use high training loads due to injuries or operations.

Conditions

Osteoarthritis (OA) of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Control

Participants of this group were active controls, exercising with a sham-BFR intervention during prehabilitation.

Group Type: ACTIVE_COMPARATOR

Sham-BFR

Intervention Type: OTHER

Six-week prehabilitation program (2/week): Unilateral Leg Press and Leg extension exercise with 30% of the individual 1RM by using a sham-BFR intervention with 20mmHg exercise pressure.

Intervention Group

Participants of this group were exercising with a BFR intervention during prehabilitation.

Group Type: EXPERIMENTAL

BFR

Intervention Type: OTHER

Six-week prehabilitation program (2/week): Unilateral Leg Press and Leg extension exercise with 30% of the individual 1RM by using a BFR intervention with an exercise pressure corresponding to 60% of the individual LOP.

Interventions

Sham-BFR

Six-week prehabilitation program (2/week): Unilateral Leg Press and Leg extension exercise with 30% of the individual 1RM by using a sham-BFR intervention with 20mmHg exercise pressure.

Intervention Type: OTHER

BFR

Six-week prehabilitation program (2/week): Unilateral Leg Press and Leg extension exercise with 30% of the individual 1RM by using a BFR intervention with an exercise pressure corresponding to 60% of the individual LOP.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Indication for TKA Surgery
• Ability to perform prehabilitation exercise

Exclusion Criteria

• Sickle Cell Anemia
• Iatrogenic changes in the vessels of the lower extremities (e.g. stents)
• Open wounds/Infection of the lower extremities

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

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Alexander Franz

Dr. med., B.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2023_D

Identifier Type: -

Identifier Source: org_study_id