SarcopeniaNCT02384161
Exercise Intermittent Isometric Handgrip and Blood Flow Restriction
A study testing Isometric exercise Intermittent in people with Sarcopenia, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Isometric exercise Intermittent
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Intermittent Isometric Handgrip Associated With Different Levels of External Vascular Compression: Acute Effects on Neuromuscular Response
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.
Read the detailed description
Muscle fatigue is a process widely disbelieved and studied in the literature. Isometric handgrip exercises have been widely utilized to explain the effects of fatigue on the strength and activation of the muscles involved in certain exercises. Among the many factors that can influence the process of muscular fatigue, blood flow available at the time of exercise is an aspect of fundamental importance, as some studies demonstrate changes in the pattern of muscle recruitment and strength recovery when the exercise is performed associated with an external obstruction of blood flow.
Resistance exercise associated with partial obstruction of blood flow (ischemic exercise) is gaining notoriety in the scientific environment, mainly due to strong evidence indicating that such activity can increase strength and muscle hypertrophy, even when performed with low intensity loads. The underlying neuromuscular mechanisms such effects are still partially unknown, and some studies have shown differences in the recruitment of motor units during its execution, and the relationship fatigue-strength after ischemic resistance exercise. Nevertheless, there are still some gaps in the literature regarding the neuromuscular responses during and after unilateral intermittent isometric handgrip protocols to failure in the associated task to partial obstruction of blood flow.
Evidence suggests that the total obstruction of blood flow decreases performance and accelerates the recovery of the isometric strength after fatigue protocols, but the effects of partial obstruction on these variables remain unknown. In the above so far, it seems that isometric fatigue protocols associated with remote obstruction (away from the venue of the exercise) blood flow can influence acutely in strength members at a distance, but it is not known as a protocol unilateral isometric fatigue associated with partial and complete obstruction of blood flow can influence acutely the strength of the contralateral limb (ie, not subject to any type of exercise). Thus, the realization of this study is justified by the possibility of answering these questions still little studied, with regard to neuromuscular factors of ischemic resistance training.
- Conditions
- Sarcopenia
- Being tested
- Isometric exercise Intermittent
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exercise IntermittentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Isometric exercise Intermittent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary isometric strength.
Recovery of maximal voluntary isometric strength in the dominant member.
Measured: 3 months
Time to task failure.
Recovery of time to task failure in the dominant member.
Measured: 3 months
electromyography activity.
Recovery electromyographic activity in the dominant member.
Measured: 3 months
Secondary outcomes (1)
Contralateral maximum voluntary isometric strength (non-dominant limb).
Contralateral maximum voluntary isometric strength (non-dominant limb).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Santos Cerqueira, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384161
- Sponsor's protocol ID
- UFPernambucoMK
- Status last verified
- Dec 2015
- First submitted
- 23 Feb 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intermittent Isometric Handgrip Associated With Different Levels of External Vascular Compression: Acute Effects on Neuromuscular Response
- ClinicalTrials.gov ID
- NCT02384161
- Acronym / sponsor ID
- UFPernambucoMK
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Muscle fatigue is a process widely disbelieved and studied in the literature. Isometric handgrip exercises have been widely utilized to explain the effects of fatigue on the strength and activation of the muscles involved in certain exercises. Among the many factors that can influence the process of muscular fatigue, blood flow available at the time of exercise is an aspect of fundamental importance, as some studies demonstrate changes in the pattern of muscle recruitment and strength recovery when the exercise is performed associated with an external obstruction of blood flow.
Resistance exercise associated with partial obstruction of blood flow (ischemic exercise) is gaining notoriety in the scientific environment, mainly due to strong evidence indicating that such activity can increase strength and muscle hypertrophy, even when performed with low intensity loads. The underlying neuromuscular mechanisms such effects are still partially unknown, and some studies have shown differences in the recruitment of motor units during its execution, and the relationship fatigue-strength after ischemic resistance exercise. Nevertheless, there are still some gaps in the literature regarding the neuromuscular responses during and after unilateral intermittent isometric handgrip protocols to failure in the associated task to partial obstruction of blood flow.
Evidence suggests that the total obstruction of blood flow decreases performance and accelerates the recovery of the isometric strength after fatigue protocols, but the effects of partial obstruction on these variables remain unknown. In the above so far, it seems that isometric fatigue protocols associated with remote obstruction (away from the venue of the exercise) blood flow can influence acutely in strength members at a distance, but it is not known as a protocol unilateral isometric fatigue associated with partial and complete obstruction of blood flow can influence acutely the strength of the contralateral limb (ie, not subject to any type of exercise). Thus, the realization of this study is justified by the possibility of answering these questions still little studied, with regard to neuromuscular factors of ischemic resistance training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total RBF + Exercise Isometric | Experimental | Other: Isometric exercise IntermittentVolunteers 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. |
| Partial RBF + Exercise Isometric | Experimental | Other: Isometric exercise IntermittentVolunteers 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. |
| Free BR + Exercise Isometric | Placebo comparator | Other: Isometric exercise IntermittentVolunteers 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. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric exercise IntermittentIntermittent 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. | Other | Free BR + Exercise Isometric, Partial RBF + Exercise Isometric, Total RBF + Exercise Isometric |
Primary outcome
Maximal voluntary isometric strength.
Time frame: 3 months
Recovery of maximal voluntary isometric strength in the dominant member.
Time to task failure.
Time frame: 3 months
Recovery of time to task failure in the dominant member.
electromyography activity.
Time frame: 3 months
Recovery electromyographic activity in the dominant member.
1 secondary outcome
Contralateral maximum voluntary isometric strength (non-dominant limb).
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise Intermittent in people with Sarcopenia, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal voluntary isometric strength. (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.