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

• ClinicalTrials.gov Identifier: NCT03618004
• Recruitment Status: Completed
• First Posted: August 7, 2018
• Last Update Posted: November 27, 2018
• Sponsor: Real Fundación Victoria Eugenia
• Information provided by (Responsible Party): Real Fundación Victoria Eugenia

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.

Condition or disease	Intervention/treatment	Phase
Women's Health: Female Athlete/Female Athlete Triad	Other: Experimental group; Other: Control group	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women. A Randomized Pilot Study
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: April 12, 2018
• Actual Study Completion Date: August 2, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental group; 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.	Other: Experimental group; 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.
Active Comparator: Control group; 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.	Other: Control group; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 ]
   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.
2. 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 ]
   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.
3. 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 ]
   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.
4. 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 ]
   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.
5. 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 ]
   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.
6. 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 ]
   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.
7. 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 ]
   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.
8. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Spain

Royal Victoria Eugenia Foundation

Madrid, Madird, Spain, 28029

Sponsors and Collaborators

Real Fundación Victoria Eugenia

Investigators

• Principal Investigator: Rubén Cuesta-Barriuso, PhD; Universidad Europea de Madrid

More Information

• Responsible Party: Real Fundación Victoria Eugenia
• ClinicalTrials.gov Identifier: NCT03618004
• Other Study ID Numbers: Kaatsu-BFR
• First Posted: August 7, 2018
• Last Update Posted: November 27, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Real Fundación Victoria Eugenia:

Restriction of blood flow; Anaerobic capacity; Subjective perception of effort; Wingate; Isometric strength

Additional relevant MeSH terms:

Female Athlete Triad Syndrome; Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Endocrine System Diseases; Feeding and Eating Disorders; Mental Disorders