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

Not Applicable

Completed

• Conditions: Ankle Sprain; Ankle Instability

• Registration Number: NCT06962943
• Lead Sponsor: Prince Sattam Bin Abdulaziz University

Brief 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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-02
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Status Verified: 2025-05
• Study First Posted: 2025-05-08
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

Inclusion Criteria

• Age ranges from 18 to 40 years.
• No other health related conditions such as diabetes or hypertension.
• Unilateral or bilateral CIA.
• Male Athletes.

Exclusion Criteria

• Knee or hip injury within the last 3 months.
• Previous ankle surgery.
• Any contraindication for BFRT application such as venous insufficiency, arterial insufficiency, history of DVT.
• Spinal lesion affecting lower limb function.
• Females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Muscle Strength	6 weeks	An isokinetic dynamometer (Physiomed Elektromedizin AG \[TP Module, CON-TREX MJ\], Schnaittach, Germany) was used for strength testing. Using the previously identified ankle evertors/invertors and plantarflexors/dorsiflexors muscles, the investigators assessed the average peak torque to body weight ratio (concentric/concentric) at an angular velocity of 60°/s. Calibration of the dynamometer was performed prior to evaluation. Submaximal three and maximal three exercise sessions were given to participants to acclimate them to the testing methodology. Each subject rested for two minutes before cycling through the active range of motion three times in a row at maximum concentric contraction. To provide sufficient recovery between contractions, a 5-minute rest interval was included in each test condition. It was expected that participants would give it their all when taking the exam. For every test, the appropriate ankle isokinetic device was used for strength testing.

Secondary Outcome Measures

Name	Time	Method
Foot and ankle disability index	6 weeks	For the purpose of clinical treatment and research investigations involving young people with chronic ankle instability, the foot and ankle disability index (FADI) self-report measure was advocated. Results showed that it was responsive, reliable, and valid for patients with chronic ankle instability. There are a total of 26 items: 22 that pertain to activities and 4 that are associated with pain. The activity item is assessed on a scale from 0 (very difficult) to 4 (very easy), whereas the FADI 4 pain items are graded from 0 (very terrible pain) to 4 (very little pain) (Hale and Hertel, 2005). The overall value of the FADI is 104 points. A score of 100% on the FADI indicated that there was no abnormality.
Fatigability level	6 weeks	The Rating of Perceived Exertion scale (RPES) was used to assess the level of fatigability, which ranges from 0 to 10, was used to describe the amount of exhaustion experienced by the participants just before to their injuries. A score of 0 indicates that there was no effort at all, while a score of 10 indicates that the exertion was exceedingly intense. The quantity of typical physical activity, measured in hours per week, that was performed, was recorded in order to ascertain the degree of physical fitness achieved

Trial Locations

Locations (1)

Walid Kamal Abdelbasset; 🇦🇪 Sharjah, United Arab Emirates