NCT06962943

Auto-regulated Blood Flow Restriction in Athletes With Recurrent Ankle Sprain

The Additional Effect of Auto-Regulated Blood Flow Restriction Exercise on Functional Performance and Muscle Fatigability in Athletes With Recurrent Ankle Sprain: A Randomized Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Prince Sattam Bin Abdulaziz University · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. Blood Flow Restriction Training (BFRT) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy resistance training. This Randomized Controlled study explores the application of BFRT in addressing Chronic Ankle Instability (CAI), focusing on its efficacy in strength gains of extrinsic foot muscles, and potential benefits in functional performance.

Detailed description

Ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. Blood Flow Restriction Training (BFRT) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy resistance training. This Randomized Controlled study explores the application of BFRT in addressing Chronic Ankle Instability (CAI), focusing on its efficacy in strength gains of extrinsic foot muscles, and potential benefits in functional performance. At the Sharjah University Medical Campus, 45 athletes from Shabab Al Ahli Club, aged 18-40, participated in this randomized control study. The investigators randomly allocated the participants into three equal groups, with 15 individuals in each group. The investigators recruited the first group to an auto-regulated blood flow restriction training plus traditional treatment program (ARBFRT+TT), the second group to a non-regulated blood flow restriction training plus traditional treatment program (NRBFRT+TT), and the third group to a traditional treatment program only without BFRT (TT group). The investigators assessed extrinsic foot muscle strength using an isokinetic device and functional performance using Functional Ankle Disability Index (FADI) and Rate of perceived exertion scale (RPES), both pre- and post 6-week treatment.

Conditions

• Ankle Sprain
• Ankle Instability

Interventions

Type	Name	Description
OTHER	Auto-regulated Blood Flow Restriction Training	This group was recruited to conduct auto-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist, the subjects were asked to perform the following exercises: standing single leg calf raises with lateral resistance using a band, seated soleus raise, single leg balance on the edge of a step clearing the front foot with band on the big toe. SmartCuff 3.0 BFRT tool was used to automatically determine the individualized 50% arterial blood occlusion pressure for the BFRT group at the femoral artery, the cuff was connected to the smart tool device for the auto-regulated group to regulate the cuff pressure during muscle contraction and relaxation. The cuff was deflated in between exercises.
OTHER	Non-regulated Blood Flow Restriction Training	This group was recruited to conduct a non-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist, the subjects were asked to perform the following exercises: standing single leg calf raises with lateral resistance using a band, seated soleus raise, single leg balance on the edge of a step clearing the front foot with band on the big toe. SmartCuff 3.0 BFRT tool was used, whilst the cuff was not connected to the device in the non-regulated blood flow restriction training group and the pressure was stabilized as the initial pressure determined by the device in the non-regulated group. The cuff was deflated in between exercises.
OTHER	Control group	This group was recruited to conduct no blood flow restriction exercise 30 min, three times a week for 6 weeks. SmartCuff 3.0 BFRT tool was used, whilst the cuff was not connected to the device and the pressure was 0 (zero) in this group. The cuff was deflated in between exercises.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-01-30
• Completion: 2024-02-02
• First posted: 2025-05-08
• Last updated: 2025-05-14

Locations

1 site across 1 country: United Arab Emirates