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

NCT03618004 | Completed

• 1 other identifier: Kaatsu-BFR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Women's Health: Female Athlete/Female Athlete Triad

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

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.

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.

Other: Control group

Interventions

Experimental group 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.

Experimental group

Control group 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.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Real Fundación Victoria Eugenia: lead

Study Sites (1)

Royal Victoria Eugenia Foundation

Madrid, Madird, 28029, Spain

Location

MeSH Terms

Conditions

Female Athlete Triad Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Relative Energy Deficiency in Sport; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: March 1, 2018
• Primary Completion: April 12, 2018
• Study Completion: August 2, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)