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

NCT ID: NCT03618004

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2018-08-02

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.

Conditions

Women's Health: Female Athlete/Female Athlete Triad

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: OTHER

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 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.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Real Fundación Victoria Eugenia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

Royal Victoria Eugenia Foundation

Madrid, Madird, Spain

Countries

Spain

Other Identifiers

Kaatsu-BFR

Identifier Type: -

Identifier Source: org_study_id