Post-surgery Muscle Preservation and Pain Reduction Through Blood Flow Restriction Training in Orthopedic Spinal Surgery

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 1, 2022

Primary Completion Date

November 1, 2024

Study Completion Date

January 1, 2025

Conditions
Muscle AtrophyPostoperative PainSpondylolisthesisSpondylodiskitis
Interventions
OTHER

Blood-Flow-Restriction Training

For the pBFR intervention, the Personalized Tourniquet System for Blood Flow Restriction from Delfi Medical Innovations Inc. (Vancouver, Canada) were used. The cuffs were applied to both lower extremities as far proximally as possible and were connected to the control device. Before starting the training program, the individual LOP was measured of both lower limb in a restring, laying position by the control device. The Intervention-Group performed the training at 80% of their individual LOP. The training was performed alternately on both lower extremities. The time intervals were set at five minutes occlusion and five minutes rest. Each leg received five intervals of BFR-induced occlusion training, resulting in a total 50 minutes of daily training. During the entire training period, the patient was in a resting position, laying in the hospital bed.

OTHER

Sham-BFR

For the sham-BFR intervention, the Personalized Tourniquet System for Blood Flow Restriction from Delfi Medical Innovations Inc. (Vancouver, Canada) were used. The cuffs were applied to both lower extremities as far proximally as possible and were connected to the control device. Before starting the training program, the individual LOP was measured of both lower limb in a restring, laying position by the control device. The Control-Group was trained with a fixed pressure of 20 mmHg, independent of their individual LOP. The training was performed alternately on both lower extremities. The time intervals were set at five minutes occlusion and five minutes rest. Each leg received five intervals of BFR-induced occlusion training, resulting in a total 50 minutes of daily training. During the entire training period, the patient was in a resting position, laying in the hospital bed.

Trial Locations (1)

53127

University Hospital Bonn, Bonn

All Listed Sponsors
lead

University Hospital, Bonn

OTHER