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Completed

NCT Number: NCT06942065

Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty

The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Atrophy Joint Diseases Muscle Atrophy Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Osteoarthritis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

About this study

The present study evaluated the impact of blood flow restriction training in the context of three-week outpatient rehabilitation following TKA, in accordance with the guidelines of the German Pension Insurance System. The in-rehabilitation and post-rehabilitation muscle status, strength, knee functionality, impairments in daily life and subjective pain perception were measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physical Fitness for Rehabilitation
  • Primary TKA surgery
  • BMI < 35

Exclusion criteria

  • Sickle Cell Anemia
  • Vascular Intervention on the lower extremities
  • Open Wounds

Treatment and study plan

Sham-BFR

Procedure

The exercise protocol for the operated leg (with sham pressure of 20mmHg) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation.

Blood Flow Restriction Training

Procedure

The exercise protocol for the operated leg (with a BFR pressure of 60% of the LOP) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation.

Primary outcomes

  1. Postoperative Pain

    Time frame: Pre- to 6 weeks Post Rehabilitation

    Postoperative Pain was assessed by visual analoge scale (0-100mm)

  2. Muscle Strength

    Time frame: Pre- to 6 weeks Post Rehabilitation

    Isometric muscle strength was measured on a DDRobotec (Dynamic Devices AG, Zurich, Switzerland), a pneumatic, computer-controlled leg press

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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