Effectiveness of Blood Flow Restriction During Aerobic Cycling

NCT04808869 | Completed

• 1 other identifier: 0891
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Blood flow restriction (BFR) training has become a popular alternate rehabilitation modality, intending to improve muscle strength, hypertrophy, metabolic response, and functional outcomes in diverse populations. However, there is a paucity of research evidence on the effectiveness of using BFR during aerobic exercise. Most BFR interventions have used BFR cuffs in two to four limbs, however, it is unknown if using BFR cuffs in a single limb instead of multiple limbs can produce the desired outcomes in muscle physiology and muscular adaptations. Therefore, we have divided the purpose of this study into the following three aims: Compare physical performance measures of balance, isokinetic muscle strength, knee stability, and aerobic capacity between cycling exercise with and without BFR. Compare physical performance measures between performing cycling exercise at 60% versus 80% blood flow occlusion. Compare physical performance measures between bilateral BFR versus single-leg BFR during a cycling protocol. These aims will be accomplished by randomizing 55 participants into five groups of eleven participants each: 1) control; 2) bilateral BFR cuffs with 60% occlusion; 3) bilateral BFR cuffs with 80% occlusion; 4) single-limb BFR with 60% occlusion; and 5) single-limb BFR with 80% occlusion. All participants will undergo balance, isokinetic knee strength, knee stability, and aerobic testing at baseline, 3-week, and 6-week follow-ups. The intervention for all groups will consist of 15 minutes cycling on a stationary ergometer at 70 revolutions/minute. A within- and between-group (5) by time (3) repeated measures analysis of variance (ANOVA) will be used to explore differences between group and time in addition to the interaction between these two.

Conditions

Exercise Intervention

Keywords

exercise; cycle ergometer; strength

Outcome Measures

Primary Outcomes (4)

• Knee valgus

  Medial deviation of the knee during a single leg step down.

  12-week

• Single leg balance

  Single leg balance on balance platform with eyes open and eyes closed for 20 seconds each.

  12-week

• Isokinetic strength

  Quadriceps and hamstring strength at three different speeds; 60, 180, 300 degrees per second.

  12-week

• Oxygen consumption during bicycle exercise protocol

  VO2 peak during graded cycling protocol

  12-week

Study Arms (5)

Control

SHAM COMPARATOR

Cycling at 70 rpm 3 times/week without any blood flow restriction cuffs

Other: Exercise

BRF 60% Unilateral

EXPERIMENTAL

Cycling at 70 rpm 3 times/week with blood flow restriction cuffs at 60% occlusion in one leg.

Other: Exercise

BFR 80% Unilateral

EXPERIMENTAL

Cycling at 70 rpm 3 times/week with blood flow restriction cuffs at 80% occlusion in one leg.

Other: Exercise

BFR Bilateral 60%

EXPERIMENTAL

Cycling at 70 rpm 3 times/week with blood flow restriction cuffs at 60% occlusion in both legs.

Other: Exercise

BFR 80% Bilateral

EXPERIMENTAL

Cycling at 70 rpm 3 times/week with blood flow restriction cuffs at 80% occlusion in both legs.

Other: Exercise

Interventions

Exercise OTHER

Cycling 3 times a week for 15 minutes at 70 rpm using blood flow restriction cuffs at different occlusions.

Also known as: Blood flow restriction training

BFR 80% Bilateral; BFR 80% Unilateral; BFR Bilateral 60%; BRF 60% Unilateral; Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults between the ages of 21-35.
• Committing to the training and testing sessions.
• Being in good health, and familiarization with physical activity and exercise.

You may not qualify if:

• Suffered a musculoskeletal injury in the lower extremities or lower back in the past three months.
• Any contraindication to aerobic exercise testing as determined by The American College of Sports Medicine.
• Any contraindication to blood flow restriction training.
• Meeting or exceeding the recommended ACSM exercise guidelines of aerobic exercise 5-times/week for \>20 minutes and strengthening exercise \> 2-days/week.
• Pregnancy for female participants (self-reported).

Sponsors & Collaborators

• University of the Incarnate Word: lead

Study Sites (1)

School of physical Therapy-University of The Incarnate Word

San Antonio, Texas, 78250, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: June 12, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)