Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy

NCT ID: NCT02790541

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-01-31

Brief Summary

Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis, increased tissue blood flow and oxygenation correlated with tissue function.

Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned organs associated with aging-related malfunctions due to restored mitochondrial function, mobilization of stem cells and induction of angiogenesis.

Detailed Description

The paradigm The accumulation of damage to molecules, cells and tissues over a lifetime that contributes to aging eventually leads to frailty and malfunction. The past decade has seen fundamental advances in our understanding of the aging process and raised optimism that interventions to slow ageing may be on the horizon. The aging process is linked to energy deficit due to tissue hypoxia and mitochondria dysfunction.

• Mitochondria dysfunction- Mitochondria are the primary generator of energy by means of ATP synthesis and their dysfunction leads to cellular function decline and degenerative changes. In addition, mitochondria dysfunction in stem cells decreases the capabilities for tissue regeneration.
• Tissue hypoxia- Atherosclerosis is a chronic inflammatory response that damages arterial blood vessels. It begins in childhood and progresses throughout life. A vicious cycle occurs as mitochondrial dysfunction accelerates atherosclerosis and the waning of microvasculature, resulting in decrease blood supply and ensuing relative tissue hypoxia. The decrease oxygen supply to the mitochondria further exacerbates mitochondrial dysfunction.

Hyperbaric oxygen can increase the partial pressure of dissolved (non-hemoglobin-bound) oxygen 20-30 fold and produce two main effects. First, it can eliminate the relative tissue hypoxia induced by atherosclerosis. Second, because mitochondria function is directly influenced by the partial pressure of dissolved oxygen, hyperbaric oxygen can amend mitochondrial dysfunction. Thus, the investigators suggest hyperbaric oxygen as a novel method for breaking the vicious cycle of degeneration and perhaps even for reversing the aging process.

The study is designed as a prospective crossover study aiming to evaluate the therapeutic effects of HBOT on the Brain, Cardiovascular and Immune system, Skin, Erectile (sexual functions), liver and Kidneys, of aging population.

After signing an informed consent form, patients will be invited for baseline evaluations. All patients would be evaluated 3 times - at baseline, after 3 months of follow up, and after additional 3 months of HBOT protocol. The evaluation will include cognitive assessment, questionnaires, MRI scans, blood tests and skin photograph and biopsy. In addition, blood tests will be drawn before and after the 20th, 40th and the 60th sessions for stem cells and mitochondria tests.

Patients will receive 60 daily sessions, 5 days/week, 90 minutes each with 5 minutes air break every 30 minutes, 100% oxygen at 2 ATA.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Hyperbaric Oxygen Therapy: 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Therapy

Intervention Type: DEVICE

60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.

Control/Crossover

Hyperbaric Oxygen Therapy: 3 months control period (no treatment) followed by 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week

Group Type: OTHER

Hyperbaric Oxygen Therapy

Intervention Type: DEVICE

60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.

Interventions

Hyperbaric Oxygen Therapy

60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.

Intervention Type: DEVICE

Other Intervention Names

HBOT

Eligibility Criteria

Inclusion Criteria

• Age≥ 65 years
• Capability to sign informed consent.
• No cardiac or cerebrovascular ischemia previous events one year prior to inclusion.

Exclusion Criteria

• Previous treatment with HBOT for any other reason during the last 3 months prior to inclusion.
• Any history of malignancy during the last year prior to inclusion.
• Severe cognitive decline (MMSA<17)
• Severe chronic renal failure (GFR <30)
• Uncontrolled diabetes mellitus (HbA1C>8, fasting glucose>200)
• Immunosuppressant from any reason
• Contraindications to perform MRI: claustrophobia, allergy to gadolinium, foreign bodies, pacemaker, etc.
• Active Smoking.
• Pulmonary diseases such as severe emphysema, moderate-severe obstructive disease.
• Medical conditions deemed by the investigator to make the patient ineligible for protocol investigations.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assaf Harofeh MC

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asaf Harofeh Medical Center

Ẕerifin, , Israel

Countries

Israel

References

Hadanny A, Sasson E, Copel L, Daniel-Kotovsky M, Yaakobi E, Lang E, Fishlev G, Polak N, Friedman M, Doenyas K, Finci S, Zemel Y, Bechor Y, Efrati S. Physical enhancement of older adults using hyperbaric oxygen: a randomized controlled trial. BMC Geriatr. 2024 Jul 3;24(1):572. doi: 10.1186/s12877-024-05146-3.

Reference Type: DERIVED

PMID: 38961397 (View on PubMed)

Other Identifiers

0172-15-ASF

Identifier Type: -

Identifier Source: org_study_id