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

NCT ID: NCT05371431

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-10-01

Brief Summary

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.

Detailed 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.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

non-BFR groups

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.

Group Type: EXPERIMENTAL

Traditional rehabilitation training

Intervention Type: OTHER

The non-BFR group undertook traditional rehabilitation training only. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Clinical assessment of grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), ROM of wrist, PRWE score, muscle stiffness and radiographic outcomes, was conducted at the 6th and 12th week from the date of initial DRF.

BFR groups

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.

Group Type: EXPERIMENTAL

Blood flow restriction combined with traditional rehabilitation training

Intervention Type: OTHER

BFR group completed the traditional rehabilitation training with a medical grade tourniquet applied on the upper arm. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Clinical assessment of grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), ROM of wrist, PRWE score, muscle stiffness and radiographic outcomes, was conducted at the 6th and 12th week from the date of initial DRF.

Interventions

Traditional rehabilitation training

The non-BFR group undertook traditional rehabilitation training only. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Clinical assessment of grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), ROM of wrist, PRWE score, muscle stiffness and radiographic outcomes, was conducted at the 6th and 12th week from the date of initial DRF.

Intervention Type: OTHER

Blood flow restriction combined with traditional rehabilitation training

BFR group completed the traditional rehabilitation training with a medical grade tourniquet applied on the upper arm. Patients participated in 2 training sessions per week with at least 48 hours rest in between for continuous 6 weeks. Clinical assessment of grip strength, pinch strength (tip pinch strength, key pinch strength and tripod pinch strength), ROM of wrist, PRWE score, muscle stiffness and radiographic outcomes, was conducted at the 6th and 12th week from the date of initial DRF.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

bin Liang, Prof

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Countries

China

References

Yang M, Liang B, Zhao X, Wang Y, Xue M, Song Q, Wang D. The effectiveness of individualized blood flow restriction training following patellar fracture surgery: a case series. BMC Musculoskelet Disord. 2025 Mar 12;26(1):247. doi: 10.1186/s12891-025-08424-2.

Reference Type: DERIVED

PMID: 40075367 (View on PubMed)

Yang M, Liang B, Zhao X, Wang Y, Xue M, Wang D. BFR Training Improves Patients' Reported Outcomes, Strength, and Range of Motion After Casting for Colles' Fracture. Med Sci Sports Exerc. 2023 Nov 1;55(11):1985-1994. doi: 10.1249/MSS.0000000000003228. Epub 2023 Jun 1.

Reference Type: DERIVED

PMID: 37259253 (View on PubMed)

Other Identifiers

KY20200820-01

Identifier Type: -

Identifier Source: org_study_id