Clinical trial NCT03618004: Technique of Restriction of Blood Flow Associated With the Ergonomic Cycle of Upper Limbs in Women
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
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health: Female Athlete/Female Athlete Triad
Keywords: Restriction of blood flow
Anaerobic capacity
Subjective perception of effort
Wingate
Isometric strength
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline isometric strength of biceps after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit]
Secondary outcomes:
measure: Change from baseline isometric strength of triceps after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline peak power after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline relative power peak after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline medium power after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline relative medium power after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline fatigue index after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline subjective perception of effort after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline heart rate after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Royal Victoria Eugenia Foundation
state: Madird
Study officials:
affiliation: Universidad Europea de Madrid
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: