Clinical trial NCT06962943: Auto-regulated Blood Flow Restriction in Athletes With Recurrent Ankle Sprain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprain
Ankle Instability
Keywords: Ankle instability
Blood flow restriction
Fatigability
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
Collaborators: name: University of Sharjah
First posted: 2025-05-08
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle Strength
timeFrame: 6 weeks
Secondary outcomes:
measure: Foot and ankle disability index
timeFrame: 6 weeks
measure: Fatigability level
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Walid Kamal Abdelbasset
Study officials:
affiliation: University of Sharjah
name: Abdelbasset
role: PRINCIPAL_INVESTIGATOR
References: