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

NCT06964022 | Completed

• 1 other identifier: 2023_D
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Subjective Pain Value

  Subjective pain perception, assessed by visual analog scale (0-100mm)

  Pre- to 6 weeks Post Surgery

• Muscle Strength

  Muscle Strength assessed by isometric maximal test (Nm)

  Pre- to 6 weeks Post Surgery

Study Arms (2)

Active Control

ACTIVE COMPARATOR

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

Other: Sham-BFR

Intervention Group

EXPERIMENTAL

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

Other: BFR

Interventions

Sham-BFR 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.

Active Control

BFR 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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Indication for TKA Surgery
• Ability to perform prehabilitation exercise

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, 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: April 30, 2025
• First Posted: May 9, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)