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- Ensaio Clínico NCT07558928
Effect of Hyperoxygenated Environment on Maximal Muscle Strength (force)
Effect of Hyperoxygenated Environment on Maximal Muscle Strength in the Mid-thigh Pull Test - a Blinded, Randomized, Sham-Controlled Crossover Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
All three major energy systems - phosphagen, glycolytic, and oxidative - contribute to any given physical effort. However, it has been widely deemed that the contribution of the oxidative energy system (aerobic) to motor tasks at the very high end of the intensity spectrum, such as maximal muscle strength efforts, is close to negligible. Hyperoxygenated environment includes the inhalation of 100% oxygen at pressures exceeding one atmosphere absolute (ATA) in order to enhance the amount of oxygen dissolved in the body tissues. During hyperbaric chamber treatment, the arterial O2 tension typically exceeds 1500 mmHg, and levels of 200-400 mmHg occur in different body tissues.
The isometric mid-thigh pull test (IMTP) is an increasingly popular means to evaluate muscle strength in a multi-joint, large muscle-mass, mostly lower-body motor task.
Our study aims to determine whether a high availability of muscle tissue oxygen, by means of hyperbaric oxygenation, can influence the putative small contribution of the oxidative energy system significantly enough to affect peak-force production in a maximal IMTP.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Eldad mr Yaakobi
- Número de telefone: 972-8-9779393
- E-mail: yaakobi.eldad@gmail.com
Locais de estudo
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Zrifin, Israel
- Recrutamento
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center
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Contato:
- Shai Efrati, MD
- Número de telefone: 972-8-9779393
- E-mail: efratishai@outlook.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Healthy
- Ages 18-45
- Participants are physically active and have a recent resistance-training experience of at least six months, ≥ 3 times a week
- Participant willing and able to read, understand and sign an informed consent
Exclusion Criteria:
- Inability to attend scheduled clinic visits or comply with the study protocol
- Active malignancy
- Active smokers
- Previous treatment of hyperbaric chamber for any reason prior to study enrollment.
- Chest pathology incompatible with pressure changes
- Major orthopedic injury at the past 3 months
- Inner ear disease
- Lung pathology
- Claustrophobia
- Previous neurologic conditions (e.g., epilepsy, brain tumors or s/p neurosurgery etc.)
- Comorbidities and medications that rule out the subject
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Hyperoxygenation active treatment
The HYPEROXYGENATED ENVIRONMENT protocol will include a single exposure to hyperoxic environment. The session will last 60 minutes, of 100% oxygen inhalation by mask at 2 ATA. 15 minutes after reaching 2 ATA and breathing 100% oxygen - IMTP test - For measurement of peak-force at baseline and under the different oxygenation conditions, each participant will be given three attempts at every IMTP test. A three-minute rest will be given between attempts, with the aim of attaining optimal recovery |
The HYPEROXYGENATED ENVIRONMENT protocol will include a single exposure to hyperoxic environment.
The session will last 60 minutes, of 100% oxygen inhalation by mask at 2 ATA
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Comparador Falso: Sham
The Sham protocol will include a single session of breathing 21% oxygen by mask while in the same multi-place chamber. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 55 minutes. 15 minutes after reaching 1.03 ATA and breathing 21% oxygen - IMTP test - For measurement of peak-force at baseline and under the different oxygenation conditions, each participant will be given three attempts at every IMTP test. A three-minute rest will be given between attempts, with the aim of attaining optimal recovery |
The Sham protocol will include a single session of breathing 21% oxygen by mask while in the same multi-place chamber.
SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 55 minutes
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Maximal static muscle force production
Prazo: Baseline evaluation, IMPT test in HBOT chamber, Approximately 4 weeks after the first visit, participants will be exposed to the opposite intervention - HOE or SHAM - and will undergo the same isometric mid-thigh pull (IMTP) test in the chamber.
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Participants will perform the isometric mid-thigh pull (IMTP) test using an analog dynamometer that will be purchased for the purpose of the study
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Baseline evaluation, IMPT test in HBOT chamber, Approximately 4 weeks after the first visit, participants will be exposed to the opposite intervention - HOE or SHAM - and will undergo the same isometric mid-thigh pull (IMTP) test in the chamber.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0131-23 ASF
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