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

NCT ID: NCT06962943

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-02-02

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.

Conditions

Ankle Sprain; Ankle Instability

Study Design

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

Study Groups

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

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.

Group Type: EXPERIMENTAL

Auto-regulated Blood Flow Restriction Training

Intervention Type: 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.

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

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.

Group Type: ACTIVE_COMPARATOR

Non-regulated Blood Flow Restriction Training

Intervention Type: 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.

Control group

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.

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sharjah

OTHER

Sponsor Role: collaborator

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Walid Kamal Abdelbasset, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelbasset

Role: PRINCIPAL_INVESTIGATOR

University of Sharjah

Locations

Walid Kamal Abdelbasset

Sharjah city, Ash Shāriqah, United Arab Emirates

Countries

United Arab Emirates

Other Identifiers

University of Sharjah

Identifier Type: OTHER

Identifier Source: secondary_id

REC-23-08-28-02-PG

Identifier Type: -

Identifier Source: org_study_id