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Trial record 85 of 157 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Injuries

The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds

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ClinicalTrials.gov Identifier: NCT03674749
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
In Ontario, wound care support has steadily increased over the years. With the growth of the aging population, the financial and psychological burden related to wound care will continue to rise. Studies have shown that structured meditation programs can improve on the recovery process for both physical and psychological disease. Therapeutic treatments like Hyperbaric Oxygen Therapy (HBOT) for chronic wounds have shown to promote angiogenesis, cerebral blood and neuroplasticity in patients with stroke, traumatic brain injury and chronic pain. By combining meditation and HBOT, this have been independently shown to improve healing and reducing costs associated with chronic wounds.

Condition or disease Intervention/treatment Phase
Wound Other: Meditation and Hyperbaric Oxygen Treament Not Applicable

Detailed Description:

Each year, Community Care Access Centers (CCAC) provide long-term wound care for over 22,000 patients in Ontario, with numbers steadily increasing with the aging population. In Ontario, the cost of community care for lower leg ulcers has been estimated at over $500 million per year. This does not include the additional cost of adjunctive HBOT, which averages over $120 thousand for a standard 40 treatment course. These costs are further compounded by the psychological comorbidities that often accompany chronic disease, although these numbers are difficult to capture. Across Canada, the health burden cost of anxiety and depression alone totals over $14 billion annually, with disability costs comparable to those associated with heart disease. Furthermore, recent evidence suggests that psychological interventions are more cost-effective than drug treatment, with comparable results.

The elderly patients with chronic non-healing wounds experience a sense of powerlessness and loss of autonomy that profoundly impacts subjective wellbeing. These psychological effects in turn compromise healing, as growing evidence suggests that psychological stress impacts wound repair [1, 2]. Recent studies have shown that structured meditation programs can improve recovery from both physical and psychological disease. For example, meditation enhances immune response [3, 4] while reducing blood pressure [5], insulin resistance [6], oxidative stress [7], inflammation [8], and other risk indices. Furthermore, meditation therapy can be broadly applied with few limitations, having successfully been used in elderly [9], ill [10] and disabled [11] populations.

Hyperbaric oxygen therapy (HBOT) is an adjuvant therapy for chronic wounds. HBOT increases oxygen delivery to tissues via inhalation of 100% oxygen at high barometric pressures. HBOT has been shown to promote angiogenesis, cerebral blood and neuroplasticity in patients with stroke, traumatic brain injury and chronic pain. Furthermore, HBOT also alleviates inflammation, reduces oxidative stress, inhibits apoptosis and stimulates signaling pathways essential for wound healing.

Patients referred for HBOT assessment often have "problem wounds" that have failed prolonged courses of standard wound care. These refractory wounds may benefit from a multimodal approach that targets both the physical and psychological manifestations of chronic disease. Meditation is a simple and economical addition to HBOT that may further enhance the rate of healing by alleviating psychological stressors. Meditation encompasses a spectrum of mindfulness-based interventions that have been shown to improve mental and physical health in randomized trials. Meditation reduces stress, pain, anxiety, depression and blood pressure while improving cognition and memory performance. A variety of specialties have begun to use meditation as a cost-effective, low-stigma adjunct to standard medical and psychiatric care.

Meditation and HBOT have been independently shown to improve healing, and may have synergistic effects when applied together. This combined intervention has the potential to improve mood while enhancing the healing process, offering improved health while reducing the costs associated with chronic wounds.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Meditation and Hyperbaric Oxygen Therapy on Cognition, Healing Process and Overall Well-being in Elderly Patients With Chronic Wounds
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hyperbaric Oxygen
Hyperbaric oxygen treatment with 100% oxygen at 2.0 ATA for 90 min, once daily, five times a week for 8 consecutive weeks
Other: Meditation and Hyperbaric Oxygen Treament
Meditation sessions will be combined with hyperbaric oxygen treatment

Experimental: Meditation with Hyperbaric Oxygen
Meditation session combined with each hyperbaric oxygen treatment with 100% oxygen at 2.0 ATA for 90 min, once daily, five times a week for 8 consecutive weeks,
Other: Meditation and Hyperbaric Oxygen Treament
Meditation sessions will be combined with hyperbaric oxygen treatment




Primary Outcome Measures :
  1. Number of patients finishing the study protocol. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. at least 3 month history of non-healing wounds, affecting lower extremities
  2. 55 years

Exclusion criteria:

  1. claustrophobia
  2. seizure disorder
  3. active asthma
  4. severe chronic obstructive pulmonary disease
  5. history of pneumothorax
  6. history of severe congestive heart failure with left ventricular ejection fraction < 25%
  7. unstable angina
  8. chronic or acute otitis media or major ear drum trauma
  9. current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
  10. recent relapse of depression, psychosis, schizophrenia, hallucinations, suicidal thoughts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674749


Contacts
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Contact: Rita Katznelson, MD, FRCPC 416-340-4800 ext 6273 rita.katznelson@uhn.ca
Contact: Ray Janisse ray.janisse@uhn.ca

Locations
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Canada, Ontario
Rouge Valley Medical Centre Recruiting
Toronto, Ontario, Canada, M1E 4B9
Contact: Anton Marinov, MD       a.marinov@utoronto.ca   
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Rita Katznelson, MD    416-340-4800 ext 6273    rita.katznelson@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto

Publications:
Harris C, Bates-Jensen B. et al. ,The Bates-Jensen Wound Assessment Tool (BWAT): Development of a Pictorial Guide for Training Nurses. Wound Care Canada, 2009, 7 (2): p 33-38

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03674749     History of Changes
Other Study ID Numbers: 18-5271
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries