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Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women (Kaatsu-BFR)

Primary Purpose

Women's Health: Female Athlete/Female Athlete Triad

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by
Real Fundación Victoria Eugenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Women's Health: Female Athlete/Female Athlete Triad focused on measuring Restriction of blood flow, Anaerobic capacity, Subjective perception of effort, Wingate, Isometric strength

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women
  • Between 18 and 40 years old
  • Physically active
  • Without orthopedic injuries that prevented them from carrying out the exercise protocol

Exclusion Criteria:

  • 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

Sites / Locations

  • Royal Victoria Eugenia Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 1, 2018
Last Updated
November 23, 2018
Sponsor
Real Fundación Victoria Eugenia
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1. Study Identification

Unique Protocol Identification Number
NCT03618004
Brief Title
Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women
Acronym
Kaatsu-BFR
Official Title
Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women. A Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Fundación Victoria Eugenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women's Health: Female Athlete/Female Athlete Triad
Keywords
Restriction of blood flow, Anaerobic capacity, Subjective perception of effort, Wingate, Isometric strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline isometric strength of biceps after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit]
Secondary Outcome Measure Information:
Title
Change from baseline isometric strength of triceps after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline peak power after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline relative power peak after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline medium power after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline relative medium power after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline fatigue index after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline subjective perception of effort after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Change from baseline heart rate after treatment and at 1 month
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women Between 18 and 40 years old Physically active Without orthopedic injuries that prevented them from carrying out the exercise protocol Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Cuesta-Barriuso, PhD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Eugenia Foundation
City
Madrid
State/Province
Madird
ZIP/Postal Code
28029
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women

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