- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Eldad mr Yaakobi
- Telefonnummer: 972-8-9779393
- E-Mail: yaakobi.eldad@gmail.com
Studienorte
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Zrifin, Israel
- Rekrutierung
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center
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Kontakt:
- Shai Efrati, MD
- Telefonnummer: 972-8-9779393
- E-Mail: efratishai@outlook.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: 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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Schein-Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Maximal static muscle force production
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0131-23 ASF
Plan für individuelle Teilnehmerdaten (IPD)
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