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

NCT06962943 | Completed

• 2 other identifiers: REC-23-08-28-02-PGUniversity of Sharjah
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprain; Ankle Instability

Keywords

Ankle instability; Blood flow restriction; Fatigability

Outcome Measures

Primary Outcomes (1)

• Muscle Strength

  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.

  6 weeks

Secondary Outcomes (2)

• Foot and ankle disability index

  6 weeks

• Fatigability level

  6 weeks

Study Arms (3)

Auto-regulated blood flow restriction training (ARBFRT+TT)

EXPERIMENTAL

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.

Other: Auto-regulated Blood Flow Restriction Training

Non-regulated blood flow restriction training (NRBFRT+TT)

ACTIVE COMPARATOR

This group was recruited to conduct non-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist.

Other: Non-regulated Blood Flow Restriction Training

Control group

PLACEBO COMPARATOR

The control group was recruited to conduct no blood flow restriction exercise (Cuff with 0 pressure) 30-min, three times a week for 6 weeks.

Other: Control group

Interventions

Auto-regulated Blood Flow Restriction Training OTHER

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.

Auto-regulated blood flow restriction training (ARBFRT+TT)

Non-regulated Blood Flow Restriction Training OTHER

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.

Non-regulated blood flow restriction training (NRBFRT+TT)

Control group OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead
• University of Sharjah: collaborator

Study Sites (1)

Walid Kamal Abdelbasset

Sharjah city, Emirate of Sharjah, 27272, United Arab Emirates

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Abdelbasset

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: November 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 2, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

AE (1)