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Clinical Trials/NCT06962943
NCT06962943CompletedNot Applicable

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

Prince Sattam Bin Abdulaziz University1 site in 1 country45 target enrollmentStarted: November 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Muscle Strength

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: Auto-regulated Blood Flow Restriction Training (Other)

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.

Intervention: Non-regulated Blood Flow Restriction Training (Other)

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.

Intervention: Control group (Other)

Outcomes

Primary Outcomes

Muscle Strength

Time Frame: 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 Outcomes

  • Foot and ankle disability index(6 weeks)
  • Fatigability level(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Walid Kamal Abdelbasset, PhD

Professor

Prince Sattam Bin Abdulaziz University

Study Sites (1)

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