NCT03983070

Brief Summary

Blood-flow restriction training (BFR) is a technique utilized to provide the benefits of high intensity exercise (strength, power, hypertrophy) when applied to exercise intensities that are insufficient to produce these benefits without BFR. The technique involves the application of an occlusive cuff (similar in design to a blood pressure cuff) over the limb of an individual that is set to occlude arterial blood flow at a given percentage during exercise. BFR has demonstrated increased strength and muscle hypertrophy compared to control interventions in various populations including: healthy subjects, athletes, post-surgery, clinical rehabilitation, and older adults. Most research on BFR has been conducted on single joint exercises and not exercises that exhibit more complex movements typically associated with daily activities. The early evidence of complex exercises combined with BFR suggests that strength and hypertrophy both improve, however more research needs to be conducted. The purpose of this project is to determine if four weeks of BFR training combined with approach rowing and deadlifts increases strength, power, aerobic capacity, and muscle size. These results will be compared to an isovolumetric control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

May 31, 2019

Last Update Submit

March 10, 2022

Conditions

Keywords

StrengthHypertrophyOxygen consumption

Outcome Measures

Primary Outcomes (1)

  • Change in Muscle Size after 4 weeks

    Cross-sectional measurement of muscle girth

    after 4 weeks of intervention

Secondary Outcomes (2)

  • Change in Maximal Oxygen Consumption after 4 weeks

    after 4 weeks of intervention

  • Change in Maximal Deadlift Strength after 4 weeks

    after 4 weeks of intervention

Other Outcomes (5)

  • Change in Numeric Pain Rating after 4 weeks

    after 4 weeks of intervention

  • Change in International Physical Activity Questionnaire - Short Form after 4 weeks

    after 4 weeks of intervention

  • Change in Resting Heart Rate after 4 weeks

    after 4 weeks of intervention

  • +2 more other outcomes

Study Arms (2)

Control Exercise Group

ACTIVE COMPARATOR

Participants allocated to the Control Exercise Group will participate in 8 total exercise sessions (2x per week for 4 weeks). Exercise sessions will include two exercise modalities 1)seated rowing ergometer and 2) dumbbell deadlifts. Exercise intensity will be individualized based upon preliminary testing with rowing at 80% maximal Watts, and deadlifts at 60% of one-repetition maximum.

Other: Seated Rowing ErgometerOther: Deadlift

Blood Flow Restriction and Exercise Group

EXPERIMENTAL

Participants allocated to the Control Exercise Group will participate in 8 total exercise sessions (2x per week for 4 weeks). Exercise sessions will include the application of blood flow restriction during two exercise modalities 1)seated rowing ergometer and 2) dumbbell deadlifts. Exercise intensity will be individualized based upon preliminary testing with rowing at 40% maximal Watts, and deadlifts at 30% of one-repetition maximum. Blow flow restriction will be applied at 80% occlusion during both exercise modalities.

Other: Seated Rowing ErgometerOther: DeadliftOther: Blood flow restriction

Interventions

Seated rowing exercise performed at a specific percentage of maximal Watts according to pre-intervention measures

Blood Flow Restriction and Exercise GroupControl Exercise Group

Deadlift exercise performed with a set of dumbbell weights at a sepcific percentage of pre-intervention one-repetition maximum.

Blood Flow Restriction and Exercise GroupControl Exercise Group

An occlusive cuff will be placed around each proximal thigh and inflated to 80% arterial occlusion during exercise sessions.

Blood Flow Restriction and Exercise Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreationally active adults (3 mo more days of moderate intensity physical activity per week, with at least some combination of aerobic and strength training).

You may not qualify if:

  • Failure to achieve clearance for exercise participation via the Par-Q+ screening tool
  • Currently pregnant or with 3 months post-partum
  • Presence of chronic low back pain
  • history of surgery to change the structure of joints within the lower extremity (joint replacement, osteotomy)
  • Known blood clotting disorder or taking blood thinner medications
  • Presence of peripheral vascular disease
  • Presence of systemic or widespread pain disorder (fibromyalgia, chronic regional pain syndrome)
  • Currently under activity limitations for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campbell University

Buies Creek, North Carolina, 27546, United States

Location

MeSH Terms

Conditions

Hypertrophy

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Bradley J Myers, DPT, DSc

    Campbell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded researcher will perform preliminary and outcomes measures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial with parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 12, 2019

Study Start

June 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 14, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations