NCT02384161

Brief Summary

Isometric handgrip exercises are used to explain the effects of fatigue on the strength and activation of the muscles involved. Blood flow available at the time of exercise can influence this fatigue process, as some studies demonstrate changes in the pattern of muscle recruitment and strength recovery when the exercise is performed in combination with an external total obstruction (through a pressure cuff or tourniquet ) blood flow. Low intensity exercises associated with external partial obstruction of blood flow has been widely used and studied, mainly due to its effect on increasing strength and muscle hypertrophy, often comparable to those observed in conventional exercises (ie, without external obstruction of blood flow) High intensity. Despite the vast literature on this method, some topics need to be better informed about the underlying neuromuscular physiology to such effects (strength and hypertrophy) and the process of fatigue during isometric exercises associated with partial obstruction of blood flow. The aim of this study is to evaluate the acute effects on neuromuscular response in healthy adults undergoing an intermittent isometric exercise protocol with different levels of external compression. In a study of the "crossover" male volunteers will be submitted to three intermittent isometric exercise protocols (with a load of 45% of maximum voluntary isometric strength) associated with three different levels of obstruction (held by a pressure cuff) blood flow (total obstruction, partial obstruction and free blood flow). The protocols will be performed on three different days (with a minimum of 48 hours between them). Will be considered as acute neuromuscular responses spending time to failure in the task, the electromyographic activity of the flexor muscles of the wrist and fingers, and the recovery curve of maximum voluntary isometric strength after exercise. The main hypothesis of this study is that exercise is performed when associated with partial obstruction of blood flow, the time spent until the failed job is similar to that seen when exercise is performed with free blood flow, and the recovery of strength and electromyographic activity will be similar to that observed in the exercise associated with total obstruction of blood flow.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

February 23, 2015

Last Update Submit

December 7, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • Maximal voluntary isometric strength.

    Recovery of maximal voluntary isometric strength in the dominant member.

    3 months

  • Time to task failure.

    Recovery of time to task failure in the dominant member.

    3 months

  • electromyography activity.

    Recovery electromyographic activity in the dominant member.

    3 months

Secondary Outcomes (1)

  • Contralateral maximum voluntary isometric strength (non-dominant limb).

    3 months

Study Arms (3)

Total RBF + Exercise Isometric

EXPERIMENTAL

Volunteers will undergo a year of intermittent isometric handgrip (intervention) in the dominant member associated with a total obstruction of blood flow, which will be conducted through a "cuff" pressure applied to the proximal region of the dominant limb.

Other: Isometric exercise Intermittent

Partial RBF + Exercise Isometric

EXPERIMENTAL

Volunteers will undergo a year of intermittent isometric handgrip (intervention) in the dominant member associated with a partial obstruction of blood flow, which will be conducted through a "cuff" pressure applied to the proximal region of the dominant limb.

Other: Isometric exercise Intermittent

Free BR + Exercise Isometric

PLACEBO COMPARATOR

Volunteers will undergo a year of intermittent isometric handgrip (intervention) in the dominant limb with the free blood flow. A 'cuff' pressure on the member of the proximal region, but with a pressure that will not interfere with blood flow will be applied.

Other: Isometric exercise Intermittent

Interventions

Intermittent isometric exercise is characterized by an interval muscle contraction (one period and another relaxed contracted period) in which there is no generation of voltage change in the length of the muscle fiber.

Free BR + Exercise IsometricPartial RBF + Exercise IsometricTotal RBF + Exercise Isometric

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers classified as irregularly active or active
  • Volunteers ranked within the normal range (18.5 to 24.9 kg / m2), the Body Mass Index (BMI).

You may not qualify if:

  • Smokers volunteers will be excluded, that are using vasoactive drugs and having fracture history in upper limbs; hypertension, venous insufficiency, cardiac insufficiency or any other cardiovascular disease; epilepsy, stroke or some other neurological disease or any other condition that prevents you from performing the exercise protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 10, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations