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Endothelial DysfunctionNCT03225898

Upper- and Lower-body Resistance Exercise With and Without Blood Flow Restriction on Hemodynamics and Vascular Function

A study testing Resistance Exercise with Blood Flow Restriction and High-intensity Resistance Exercise in people with Endothelial Dysfunction and Autonomic Dysfunction, run by Kent State University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The American College of Sports Medicine (ACSM) recommends that resistance exercise performed at greater than 70% one repetition maximum (1 RM) is necessary to induce strength gains and muscular hypertrophy (ACSM, 2009). Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
Resistance Exercise with Blood Flow Restriction and High-intensity Resistance Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
14 Jun 2017to 13 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 3 days per week of resistance training for 1 year
  • 18-30 years of age

Who cannot join

  • include a recent smoking history (< 6 months)
  • obesity (defined as a body mass index ≥ 30 kg/m2)
  • skeletal and orthopedic injuries
  • cancer
  • known cardiovascular disease
  • open wounds
Show all 11Show fewer
  • history of blood clots
  • metabolic disease
  • uncontrolled hypertension (resting brachial BP ≥ 140/90 mmHg)
  • pregnancy, planning to get pregnant
  • taking any medications or supplements known to affect blood pressure, heart rate, or vascular function

Trial locations and contacts

1 site in 1 country.

J. Derek Kingsley, PhD contact

330-672-0222

jkingsle@kent.edu

United States1 site, 1 recruiting
  • Cardiovascular Dynamics Laboratory

    Kent, Ohio, 44242

    J. Derek Kingsley, PhD, 330-672-0222, jkingsle@kent.edu

    Recruiting

Other trials in United States

About this study

The American College of Sports Medicine (ACSM) recommends that resistance exercise performed at greater than 70% one repetition maximum (1 RM) is necessary to induce strength gains and muscular hypertrophy (ACSM, 2009). However, previous work has shown resistance exercise at high intensity increases the rate of injury. Blood flow restriction (BFR) exercise is a method that is used to compress the blood vessels to the exercising muscle in order to reduce blood flow to the limb with the use of low-intensity resistance. Researchers have suggested that resistance exercise at intensities as low as 20-30% 1-repetition maximum with BFR increases in muscle mass, muscular endurance, and gains in strength. However, the acute heart and blood vessel changes in response to BFR are not clear. Work by our laboratory (Tai et al., 2016) has demonstrated that immediately following acute resistance exercise at moderate intensity (75% 1 RM) without BFR, there are no changes in aortic and brachial systolic and diastolic blood pressure (BP), but there are increases in the pressure of the reflective wave (augmentation pressure). This suggests that the arterial wall is stiff, and may in turn result in thickening of the arterial wall. However, the data are limited and these responses may not be universally accepted. In addition, these studies used primarily lower-body resistance exercises (squat, leg extension, and leg flexion), and did not assess changes in heart and blood vessel function. Previous researchers have demonstrated that upper-body exercise induces higher BP and heart rate (HR) than lower-body exercise. However, the effects of upper- and lower-body resistance exercise with BFR on heart and blood vessel function are still unclear. Therefore, understanding the effects of upper- and lower-body resistance exercise with BFR on heart and blood vessel function using weight machines, specifically the chess press, latissimus dorsi pulldown, knee extension, and knee flexion may significant impact how the resistance training program is prescribed.

Read the detailed description

Participants will come to the Cardiovascular Dynamics Laboratory at Kent State University for 4 separate visits. On the first visit, participants will undergo an orientation and decide if they want to sign the informed consent. If they decide to consent, they will be assigned randomly to either upper- or lower-body group, and fill out Physical Activity Readiness Questionnaire (PAR-Q) and Health Participant Questionnaire then be measured for height, weight, body composition (7-sites skin fold), arterial occlusion pressure (determine the pressure that occlude blood flow using a doppler device on brachial or femoral artery, and a 13-cm nylon cuff at the proximal end of right arm or right leg then inflate the cuff to 50 mmHg and increases by 1 mmHg per second until the doppler device cannot detect blood flow) and 1 RM which they will move maximum amount of weight 1 time through a full range of motion on the chess press and latissimus dorsi pulldown or knee extension and knee flexion. A certified strength and conditioning specialist will adjust the form, spot the lifts, and provide feedback if needed. The second visit consists of 1-repetition maximum verification that participants will be measured 1-repetition maximum on the chess press and latissimus dorsi pulldown or knee extension and knee flexion again to ensure their maximal strength. For the third and fourth visits, the participants will come to the Cardiovascular Dynamics Laboratory to have their responses to either acute upper- or lower-body resistance exercise with and without BFR quantified. Participants will arrive at the laboratory having avoided caffeine, alcohol, and strenuous exercise for 24 hours, and at least 3 hours without food before data collection. Participants will have their hemodynamics and vascular function measured before and after either acute upper- or lower-body resistance exercise with or without BFR. Hemodynamic measurements will include pulse wave analysis (PWA) using a SphygmoCor (AtCor Medical, Sydney, Australia) device. Heart rate and blood pressure will be monitored using 3 leads electrocardiograph (ECG) and on the middle finger of the right hand, respectively. A 5-minute ECG will be collected, and participants will be breathing with a metronome at the rate of 12 breaths/minute. PWA provides information about aortic and brachial systolic and diastolic BP, as well as measures of wave reflection that give insight into central arterial modulation such as augmentation pressure and the augmentation index. BP will be measured twice separated by 1 minute by an oscillometric device. After that the investigators will assess vascular function via pulse wave velocity. During PWA measurements, there will be cuffs on right arm and right leg, and a tonometer will be placed on the carotid artery on the neck. Peripheral arterial mechanics will be measured by strain gauge plethysmography (EC-6; DE Hokanson Inc., Bellevue, WA, USA) on the forearm close to the elbow in order to determine forearm blood flow and vasodilatory capacity (peak blood flow). There will be cuffs on the upper left arm and on the left wrist. The wrist Cuff will be inflated to 220 mmHg 1 minute prior to data collection and throughout. The Upper arm cuff will be inflated to 50 mmHg to occlude venous flow for measurement of arterial flow. Ninety seconds of measurement of flow will occur. Once this is completed, the cuff on the upper arm will be inflated to 220 mmHg for 5 minutes to occlude blood flow. After that, the pressure in the cuff will be released and measurements of blood flow will be taken for the next 3 minutes with the wrist cuff will be inflated to 220 mmHg 1 minute prior to data collection and throughout. The upper-(chess press and latissimus dorsi pulldown) and lower-body (knee extension and knee flexion) resistance exercise with BFR will consists of 4 sets of 30, 15, 15, and 15 repetitions at 30% 1 RM with 30 seconds rest between sets and 2 minutes rest between exercises. The upper- and lower-body resistance exercise without BFR will consists of 4 sets of 8 repetitions at 70% 1 RM with 60 seconds rest between sets and 2 minutes rest between exercises. Participants' arms or legs will be wrapped using elastic cuffs at the most proximal limbs. At 40% of arterial occlusion pressure will be used to induce BFR. Three minutes warm up and three minutes cool down on the cycle ergometer will be given before and after resistance exercise. Immediately after completion of the acute bouts of resistance exercise, the investigators will assess PWA and ECG at 10, 20, 30, 40, 50, and 60 minutes post exercise, and BF at 20 and 60 minutes post exercise.

Being tested
Resistance Exercise with Blood Flow Restriction, High-intensity Resistance Exercise
Keywords
blood flow restriction, resistance exercise
Medical subject headings
Primary Dysautonomias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance Exercise with Blood Flow RestrictionOther

    Also called KATTSU

    A cuff will be used to restrict blood flow to the extremities.

  • High-intensity Resistance ExerciseOther

    Participants will follow a conventional resistance exercise regime.

Study groups in NCT03225898
Study groupRoleWhat they receive
Resistance Exercise with Blood flow restrictionExperimentalSubjects will perform 4 sets with 30, 15, 15, 15 repetitions at 30% 1RM.
Receives: Other: Resistance Exercise with Blood Flow Restriction
High-intensity resistance exerciseActive comparatorSubjects will perform 4 sets of 8 repetitions at 70% 1RM.
Receives: Other: High-intensity Resistance Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Autonomic Modulation over 1 hour

    Heart rate variability

    Measured: Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise

Secondary outcomes (1)
  1. Change from Baseline Endothelial Function over 1 hour

    Pulse wave velocity

    Measured: Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start14 Jun 2017
  3. Primary completion13 Jun 2018 (estimated)
  4. Study completion13 Jun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03225898
Sponsor's protocol ID
17-285
Status last verified
Jul 2017
First submitted
10 Jul 2017
Last updated
24 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Madarame H, Neya M, Ochi E, Nakazato K, Sato Y, Ishii N. Cross-transfer effects of resistance training with blood flow restriction. Med Sci Sports Exerc. 2008 Feb;40(2):258-63. doi: 10.1249/mss.0b013e31815c6d7e.

    PubMed 18202577
  • Takarada Y, Sato Y, Ishii N. Effects of resistance exercise combined with vascular occlusion on muscle function in athletes. Eur J Appl Physiol. 2002 Feb;86(4):308-14. doi: 10.1007/s00421-001-0561-5.

    PubMed 11990743
  • Rossow LM, Fahs CA, Sherk VD, Seo DI, Bemben DA, Bemben MG. The effect of acute blood-flow-restricted resistance exercise on postexercise blood pressure. Clin Physiol Funct Imaging. 2011 Nov;31(6):429-34. doi: 10.1111/j.1475-097X.2011.01038.x. Epub 2011 Jul 7.

    PubMed 21981453
  • Figueroa A, Vicil F. Post-exercise aortic hemodynamic responses to low-intensity resistance exercise with and without vascular occlusion. Scand J Med Sci Sports. 2011 Jun;21(3):431-6. doi: 10.1111/j.1600-0838.2009.01061.x. Epub 2010 Jan 31.

    PubMed 20136757

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Exercise with Blood Flow Restriction and High-intensity Resistance Exercise in people with Endothelial Dysfunction and Autonomic Dysfunction, run by Kent State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact J. Derek Kingsley, PhD (330-672-0222, jkingsle@kent.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Autonomic Modulation over 1 hour (time frame: Rest, 10 min, 20 min, 30 min, 40 min, 50 min, 60 min post exercise). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03225898, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.

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Clinical Trial NCT03225898 | AzTrials