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Completed

NCT Number: NCT05615831

The Impact of Exercise With Blood Flow Restriction: Sex and Age Differences

The primary objective is to investigate whether six weeks of resistance training, in combination with blood flow restriction, produces a different adaptation in fat-free mass between males and females that are not physically active. The secondary objective is to compare changes in physical function, physical performance, and blood biomarkers between males and females following resistance training and blood flow restriction.

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Key information

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Brunswick - Kinesiology

Fredericton, New Brunswick, E3B 5A3, Canada

About this study

Previous studies indicated a reduced workload (i.e., lifting lighter weight) combined with blood flow restriction leads to increased fat-free mass and muscle strength. However, females have been underrepresented in the blood flow restriction literature. Therefore, no study has investigated whether males and females of different age groups have different adaptations in fat-free mass, muscle strength, and performance outcomes following resistance training using blood flow restriction.

The primary objective will be to investigate sex differences in fat-free mass following six weeks of resistance training combined with blood flow restriction in young and older adults.

The secondary objective is to investigate sex differences in muscle strength, physical performance, and blood biomarkers between males and females following resistance training and blood flow restriction.

Briefly, participants between 19-30 years and 65 years and older will be recruited to participate in this study. Participants will present to the laboratory for two baseline testing visits interspersed with a minimum of four days. The first testing visit will include a variety of questionnaires, a blood draw, lipid and glucose, a dual-energy x-ray absorptiometry scan, anthropometrics, and a submaximal VO2. The second visit will include several physical function tests, such as the short physical performance battery and the Y-balance test, as well as a high-intensity isokinetic fatigue test using isokinetic dynamometry and 1-repetition maximum testing.

Upon completion of baseline testing, participants are enrolled in the exercise program. The first exercise session includes a blood draw before and immediately after the training session. This procedure will be duplicated at the final exercise session at the end of the six weeks.

Participants' full occlusion will be estimated using the formula developed by Loenneke et al. (2015). Then each participant's occlusion will be set at 60% of each individual's total limb occlusion. This will be used in combination with the following exercises incline chest press, seated row, leg press, knee extension, and knee flexion performed at 30% of 1RM. The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise. There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated.

Following the completion of the six weeks of exercise, participants will again present to the laboratory for two follow-up visits similar to the first two baseline visits.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between the ages of 19 and 100 years
  • Sedentary (not meeting physical activity guidelines), but otherwise healthy

Exclusion criteria

  • Aged outside the threshold
  • Uncontrolled hypertension
  • Presence of cardiovascular disease
  • Either surgery, bone fracture, or skin graft within the previous three months
  • Uncontrolled diabetes mellitus
  • Pregnancy
  • Individuals taking medications known to increase risk of blood clotting

Treatment and study plan

Resistance Training with Blood flow restriction

Behavioral

Participants will perform six weeks of blood flow restriction (60% occlusion) combined with resistance training at 30% of 1RM. The intervention comprises five exercises: incline chest press, seated row, leg press, knee extension, and knee flexion. The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise. There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated.

Primary outcomes

  1. Muscle hypertrophy

    Time frame: Baseline and 6 weeks

    Change in fat-free mass

Secondary outcomes

  1. Strength

    Time frame: Baseline and 6 weeks

    Change in 1-repetition maximum

  2. Muscle Power

    Time frame: Baseline and 6 weeks

    Change in vertical jump score

  3. Muscle Endurance

    Time frame: Baseline and 6 weeks

    Change in knee extension and flexion

  4. Changes in physical function

    Time frame: Baseline and 6 weeks

    Changes in short physical performance battery, senior fitness test, and Y-balance test

  5. Changes in blood biomarkers

    Time frame: Baseline and 6 weeks post-intervention and pre and post an acute bout of resistance training at baseline and and after 6 weeks

    Changes in circulating blood biomarkers

Sponsors and collaborators

Lead sponsor

University of New Brunswick

Other

Collaborators

  • Public Health Agency of Canada (PHAC)

Registry information

Official study title

The Impact of Exercise With Blood Flow Restriction: Sex and Age Differences on Physical Performance, Muscle Hypertrophy, and Blood Biomarkers

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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