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

NCT06942065 | Completed

• 1 other identifier: 2023_E
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis (OA) of the Knee; Muscle Atrophy

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain

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

  Pre- to 6 weeks Post Rehabilitation

• Muscle Strength

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

  Pre- to 6 weeks Post Rehabilitation

Study Arms (2)

Control Group

SHAM COMPARATOR

Control sham condition which performed the exercise with a fixed pressure of 20mmHg

Procedure: Sham-BFR

Blood Flow Restriction Group

EXPERIMENTAL

This intervention groups performed training on the operated limb with a BFR pressure corresponding to 60% of the individual limb occlusion pressure

Procedure: Blood Flow Restriction Training

Interventions

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.

Control Group

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.

Blood Flow Restriction Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

MeSH Terms

Conditions

Osteoarthritis; Muscular Atrophy

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

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 16, 2025
• First Posted: April 24, 2025
• Study Start: June 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)