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The Effect of Blood Flow Restriction Training on the Patients of Distal Radius Fracture

N

Nanjing Medical University

Status

Completed

Conditions

Distal Radius Fracture

Treatments

Other: Blood flow restriction combined with traditional rehabilitation training
Other: Traditional rehabilitation training

Study type

Interventional

Funder types

Other

Identifiers

NCT05371431
KY20200820-01

Details and patient eligibility

About

The aim of this study was to compare the effect of blood flow restriction (BFR) training and traditional rehabilitation training on grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), range of motion (ROM) of wrist, patient-rated wrist evaluation (PRWE) score, muscle stiffness and radiographic outcomes in distal radius fracture (DRF) patients during a post-treatment rehabilitation program.

Full description

This study is a randomized controlled study. Patients in the non-BFR group underwent a traditional rehabilitation training. Traditional rehabilitation training is designed based on post injury rehabilitation guidelines. This guideline recommends that the early rehabilitation of DRF should be progressive, with training loads ranging from self-weight to full weight bearing depending on the patient's individual situation. During the six weeks, a progressive training load has been applied to the patients. First week: no weight bearing. Second to sixth week: resistance was increased by 1LB (~0.45 kg) for individual training only if a participant could consecutively achieve at least 30/15/15/15 (75 total) repetitions for both training sessions within a given training week. The exercises include grip and pinch, wrist flexion with forearm pronated, wrist extension with forearm pronated, wrist flexion with forearm supinated, wrist extension with forearm supinated, prayer sign (wrist flexion), prayer sign (wrist extension), forearm pronation, and forearm supination. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. BFR training twice a week for at least 6 weeks has been reported to increase muscle hypertrophy and strength. The BFR group underwent the same traditional rehabilitation training program but combined with BFR implemented by a medical grade tourniquet system (ATS 4000 TS,Zimmer Surgical, Inc. Dover). The tourniquet system consists of a ATS 4000 tourniquet system, and a tourniquet cuff (10 cm × 46 cm). The ATS 4000 tourniquet system tailors the individualized tourniquet pressure to each patient following determination of the limb occlusion pressure (LOP), and studies have shown that 50% LOP is safe and effective in the rehabilitation of DRF. When the tourniquet system was used, LOPs were reassessed for every session before training, and pressures were continually monitored. Participants were to perform the entirety of each training (including intra-set rest periods) under 50% LOP with the tourniquets released during the 2-minute rest periods between sets.

Enrollment

25 patients

Sex

All

Ages

50 to 73 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Between the ages of 50 and 75 years
  • Colles' fracture
  • No history of wrist injury or joint deformity
  • No other types of upper limb injuries occurred in the last 3 months
  • No cardiovascular diseases

Exclusion criteria

  • Concurrent ipsilateral upper limb fracture
  • Concurrent bilateral upper limb fractures
  • History of surgery or any invasive procedure on the upper limb
  • History of peripheral arterial disease or deep vein thrombosis
  • History of cancer that has generated limitations or restrictions to physical exercise

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

25 participants in 2 patient groups

non-BFR groups
Experimental group
Description:
Traditional rehabilitation training is designed according to postoperative orthopaedic rehabilitation guidelines. Traditional rehabilitation trainings include grip and pinch, wrist flexion with forearm pronated, wrist extension with forearm pronated, wrist flexion with forearm supinated, wrist extension with forearm supinated, prayer sign (wrist flexion), prayer sign (wrist extension), forearm pronation, forearm supination. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks.
Treatment:
Other: Traditional rehabilitation training
BFR groups
Experimental group
Description:
Patients in the BFR group underwent the same traditional rehabilitation training protocol with non-BFR utilizing a medical grade tourniquet system (ATS 4000 TS,Zimmer Surgical, Inc. Dover). The ATS 4000 tourniquet system tailors the individualized tourniquet pressure to each patient following determination of the limb occlusion pressure (LOP), and studies have shown that 50% LOP is safe and effective in the rehabilitation of DRF. When the tourniquet system was used, LOPs were reassessed for every session before training, and pressures were continually monitored. Participants were to perform the entirety of each training (including intra-set rest periods) under 50% LOP with the tourniquets released during the 2-minute rest periods between sets. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks.
Treatment:
Other: Blood flow restriction combined with traditional rehabilitation training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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