Women's Health: Female Athlete/Female Athlete TriadKaatsu-BFRNCT03618004
Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women
A study testing Experimental group in people with Women's Health: Female Athlete/Female Athlete Triad, run by Real Fundación Victoria Eugenia at 1 site in Spain.
Trial summary
Finding alternatives to improve variables such as strength and anaerobic resistance is a subject of highly studied clinical intervention. The use of vascular occlusion associated with physical exercise has shown efficacy in improving these aspects. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health: Female Athlete/Female Athlete Triad
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 2 Aug 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Between 18 and 40 years old
- Physically active
- Without orthopedic injuries that prevented them from carrying out the exercise protocol
Who cannot join
- Diagnosis of chronic musculoskeletal, neurological or cardiorespiratory diseases
- With diagnosis of arterial hypertension, deep vein thrombosis or diabetes
- Pregnant
- Not sign the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women. A Randomized Pilot Study
Finding alternatives to improve variables such as strength and anaerobic resistance is a subject of highly studied clinical intervention. The use of vascular occlusion associated with physical exercise has shown efficacy in improving these aspects.
The objective is to analyze the effectiveness of upper limb training with vascular occlusion (Kaatsu training) for the improvement of isometric strength and anaerobic capacity in women aged 18 to 38 years.
Read more
Study design. Randomized, prospective, single-blind, follow-up clinical study. The selected sample will be randomized into two groups: experimental and control. The intervention will consist of ergonomic exercises with and without vascular occlusion. Isometric strength will be assessed with a manual dynamometer, anaerobic capacity and peak power (anaerobic alactic system) and average power (anaerobic lactic system) with the wingate test, and subjective perception of effort with the Borg scale. The intervention will last 4 weeks, with 3 weekly sessions of 10 minutes each. A descriptive statistical analysis will be carried out among the dependent and independent variables of both groups. With the Kolmogórov distribution normality test and with the Anova and t-student tests for analysis of repeated measures.
Expected results. The investigators intend to observe improvement of isometric biceps and triceps strength and the anaerobic capacity of the group treated with vascular occlusion.
Read the detailed description
The use of peripheral vascular occlusion in low intensity resistance exercises is a simple, safe and effective method, indicated for healthy individuals or with cardio-respiratory diseases, in the prevention of atrophy due to disuse, within the post rehabilitation approach. -surgical intervention and to improve the performance of athletes. Several studies evaluated the use of blood flow restriction prior to aerobic and anaerobic exercises, with heterogeneous results, without consensus. With this, our research proposal is a pioneer, as there is no other study that has investigated the use of upper limb vascular occlusion during anaerobic activity in an arm ergometer cycle. This could benefit individuals who need to maintain their anaerobic conditioning and who, for some reason, are unable to use the lower limbs. In addition, it could benefit in the performance and improvement of the physical fitness of athletes in wheelchairs of various modalities, which have their functions preserved in the upper limbs. Only a similar study showed the efficacy of this intervention model, but in lower limbs. The prevalence of men in published studies of anaerobic capacity with the WinGate test, with few studies recruiting women, indicates the need to perform the study with a female sample.
- Being tested
- Experimental group, Control group
- Keywords
- Restriction of blood flow, Anaerobic capacity, Subjective perception of effort, Wingate, Isometric strength
- Medical subject headings
- Female Athlete Triad Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
The intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg.
The subjects of the experimental group made use of the restriction of blood flow, using a pressure cuff coupled in the most proximal region of the arm, 10 cm wide. The pressure was calculated based on the initial systolic pressure of the subjects.
Control groupOther
The intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg.
The subjects in the control group did not use pressure cuffs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg.
The subjects of the experimental group made use of the restriction of blood flow, using a pressure cuff coupled in the most proximal region of the arm, 10 cm wide. The pressure was calculated based on the initial systolic pressure of the subjects. Receives: Other: Experimental group |
| Control group | Active comparator | The intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg.
The subjects in the control group did not use pressure cuffs. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline isometric strength of biceps after treatment and at 1 month
A Lafayette Manual Muscle Testing System force dynamometer (model 01165, USA) was used. The subject was standing with the trunk straight, the shoulders in neutral position with the arms aligned to the trunk and the elbows in 90 degrees of flexion. The evaluator requested a maximum voluntary isometric muscle contraction in elbow flexion, maintaining it for 5 seconds. Three repetitions were performed, with 5 minutes of rest between each series, the reference value being the average of the value obtained between the 3 repetitions.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit]
Secondary outcomes (8)
Change from baseline isometric strength of triceps after treatment and at 1 month
A Lafayette Manual Muscle Testing System force dynamometer (model 01165, USA) was used. The subject was standing with the trunk straight, the shoulders in neutral position with the arms aligned to the trunk and the elbows in 90 degrees of flexion. The evaluator requested a maximum voluntary isometric muscle contraction in elbow extension, maintaining it for 5 seconds. Three repetitions were performed, with 5 minutes of rest between each series, the reference value being the average of the value obtained between the 3 repetitions.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline peak power after treatment and at 1 month
The WinGate test was used. The equipment used was an ergonomic clico for upper limbs (Excite® top seat, technogyn, Brazil). Each subject was placed seated, so that the center of the glenohumeral joint was aligned with the axis of the cranks of the equipment, with 90 degrees of knee flexion, which were aligned with shoulders and feet. The horizontal distance was adjusted so that the elbows were not in maximum extension and allowing the comfort of the participants.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline relative power peak after treatment and at 1 month
The WinGate test was used. The equipment used was an ergonomic clico for upper limbs (Excite® top seat, technogyn, Brazil). Each subject was placed seated, so that the center of the glenohumeral joint was aligned with the axis of the cranks of the equipment, with 90 degrees of knee flexion, which were aligned with shoulders and feet. The horizontal distance was adjusted so that the elbows were not in maximum extension and allowing the comfort of the participants.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline medium power after treatment and at 1 month
The WinGate test was used. The equipment used was an ergonomic clico for upper limbs (Excite® top seat, technogyn, Brazil). Each subject was placed seated, so that the center of the glenohumeral joint was aligned with the axis of the cranks of the equipment, with 90 degrees of knee flexion, which were aligned with shoulders and feet. The horizontal distance was adjusted so that the elbows were not in maximum extension and allowing the comfort of the participants.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline relative medium power after treatment and at 1 month
The WinGate test was used. The equipment used was an ergonomic clico for upper limbs (Excite® top seat, technogyn, Brazil). Each subject was placed seated, so that the center of the glenohumeral joint was aligned with the axis of the cranks of the equipment, with 90 degrees of knee flexion, which were aligned with shoulders and feet. The horizontal distance was adjusted so that the elbows were not in maximum extension and allowing the comfort of the participants.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline fatigue index after treatment and at 1 month
The WinGate test was used. The equipment used was an ergonomic clico for upper limbs (Excite® top seat, technogyn, Brazil). Each subject was placed seated, so that the center of the glenohumeral joint was aligned with the axis of the cranks of the equipment, with 90 degrees of knee flexion, which were aligned with shoulders and feet. The horizontal distance was adjusted so that the elbows were not in maximum extension and allowing the comfort of the participants.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline subjective perception of effort after treatment and at 1 month
The subjective perception of effort was evaluated with the Borg CR-10 scale. One minute after the end of the evaluation, the effort perceived by the subjects was quantified from 0 to 10, with 0 the minimum perceived effort and 10 the maximum.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline heart rate after treatment and at 1 month
The heart rate was assessed through a cardiac frequency meter (model Onrhythm 310, Geonaute, France). The resting heart rates were evaluated and one minute after the intervention.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Mar 2018
- Primary completion12 Apr 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's Health: Female Athlete/Female Athlete TriadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618004
- Sponsor's protocol ID
- Kaatsu-BFR
- Acronym
- Kaatsu-BFR
- Status last verified
- Nov 2018
- First submitted
- 1 Aug 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women. A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03618004
- Acronym / sponsor ID
- Kaatsu-BFR / Kaatsu-BFR
- Keywords
- Restriction of blood flow, Anaerobic capacity, Subjective perception of effort, Wingate, Isometric strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Finding alternatives to improve variables such as strength and anaerobic resistance is a subject of highly studied clinical intervention. The use of vascular occlusion associated with physical exercise has shown efficacy in improving these aspects.
The objective is to analyze the effectiveness of upper limb training with vascular occlusion (Kaatsu training) for the improvement of isometric strength and anaerobic capacity in women aged 18 to 38 years.
Study design. Randomized, prospective, single-blind, follow-up clinical study. The selected sample will be randomized into two groups: experimental and control. The intervention will consist of ergonomic exercises with and without vascular occlusion. Isometric strength will be assessed with a manual dynamometer, anaerobic capacity and peak power (anaerobic alactic system) and average power (anaerobic lactic system) with the wingate test, and subjective perception of effort with the Borg scale. The intervention will last 4 weeks, with 3 weekly sessions of 10 minutes each. A descriptive statistical analysis will be carried out among the dependent and independent variables of both groups. With the Kolmogórov distribution normality test and with the Anova and t-student tests for analysis of repeated measures.
Expected results. The investigators intend to observe improvement of isometric biceps and triceps strength and the anaerobic capacity of the group treated with vascular occlusion.
Detailed description
The use of peripheral vascular occlusion in low intensity resistance exercises is a simple, safe and effective method, indicated for healthy individuals or with cardio-respiratory diseases, in the prevention of atrophy due to disuse, within the post rehabilitation approach. -surgical intervention and to improve the performance of athletes. Several studies evaluated the use of blood flow restriction prior to aerobic and anaerobic exercises, with heterogeneous results, without consensus. With this, our research proposal is a pioneer, as there is no other study that has investigated the use of upper limb vascular occlusion during anaerobic activity in an arm ergometer cycle. This could benefit individuals who need to maintain their anaerobic conditioning and who, for some reason, are unable to use the lower limbs. In addition, it could benefit in the performance and improvement of the physical fitness of athletes in wheelchairs of various modalities, which have their functions preserved in the upper limbs. Only a similar study showed the efficacy of this intervention model, but in lower limbs. The prevalence of men in published studies of anaerobic capacity with the WinGate test, with few studies recruiting women, indicates the need to perform the study with a female sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupThe intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg. The subjects of the experimental group made use of the restriction of blood flow, using a pressure cuff coupled in the most proximal region of the arm, 10 cm wide. The pressure was calculated based on the initial systolic pressure of the subjects. |
| Control group | Active comparator | Other: Control groupThe intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg. The subjects in the control group did not use pressure cuffs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women
- Between 18 and 40 years old
- Physically active
- Without orthopedic injuries that prevented them from carrying out the exercise protocol
Key exclusion criteria (4 listed)
- Diagnosis of chronic musculoskeletal, neurological or cardiorespiratory diseases
- With diagnosis of arterial hypertension, deep vein thrombosis or diabetes
- Pregnant
- Not sign the informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupThe intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg. The subjects of the experimental group made use of the restriction of blood flow, using a pressure cuff coupled in the most proximal region of the arm, 10 cm wide. The pressure was calculated based on the initial systolic pressure of the subjects. | Other | Experimental group |
| Control groupThe intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg. The subjects in the control group did not use pressure cuffs. | Other | Control group |
Primary outcome
Change from baseline isometric strength of biceps after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit]
A Lafayette Manual Muscle Testing System force dynamometer (model 01165, USA) was used. The subject was standing with the trunk straight, the shoulders in neutral position with the arms aligned to the trunk and the elbows in 90 degrees of flexion. The evaluator requested a maximum voluntary isometric muscle contraction in elbow flexion, maintaining it for 5 seconds. Three repetitions were performed, with 5 minutes of rest between each series, the reference value being the average of the value obtained between the 3 repetitions.
8 secondary outcomes
Change from baseline isometric strength of triceps after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline peak power after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline relative power peak after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline medium power after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline relative medium power after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline fatigue index after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline subjective perception of effort after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline heart rate after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Women's Health: Female Athlete/Female Athlete Triad, run by Real Fundación Victoria Eugenia at 1 site in Spain.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Nov 2018. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline isometric strength of biceps after treatment and at 1 month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2018.