Low Level Laser Therapy Impact on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients

Study Overview
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Brief Summary
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Alzheimer's is a type of dementia that affects memory, thinking and behavior. Symptoms eventually grow severe enough to interfere with daily tasks. this study aimed to delay the deterioration of anemic elderly condition as memory affection interfere with daily life activities and social interaction

Detailed Description
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Alzheimer's disease is the commonest cause of dementia and describes a clinical syndrome made up of three domains. First, a neuro-psychological domain encompassing those deficits of cognitive function such as amnesia (memory loss), aphasia (language disturbance), apraxia (the inability to carry out motor tasks despite intact motor functions) and agnosia (the inability to recognize people or objects despite intact sensory functions). Second, a group of psychiatric symptoms and behavioral disturbances, which have been termed neuro-psychiatric features, non-cognitive phenomena, or behavioral and psychological symptoms of dementia Alzheimer's disease is substantially increased among people aged 65 years or more, with a progressive decline in memory, thinking, language and learning capacity. Alzheimer's disease should be differentiated from normal age-related decline in cognitive function, which is more gradual and associated with less disability. Diabetes, hypertension, smoking, obesity, and dyslipidemia have all been found to increase risk as well a history of brain trauma, cerebrovascular disease, and vasculopathies. Dementia affects approximately 5%-8% of individuals over age 65, 15%- 20% of individuals over age 75, and 25%-50% of individuals over age 85. Alzheimer disease is the most common dementia, accounting for 50%-75% of the total, with a greater proportion in the higher age ranges Dementia is expensive. The financial costs of managing Alzheimer's disease are enormous. The cost of illness is high in terms of both public and private resources. Families and caregivers who are required to provide care and patients affected by dementia also pay a high price in terms of their quality of life The primary goals of treatment are to maximize the patient's ability to function in daily life, maintain quality of life, slow the progression of symptoms, and treat depression or disruptive behaviors Low level laser therapy is a safe, non-invasive, and non-thermal modality that is based on a strong body of research dating back to the 1960.It involved in treating several conditions, the mechanisms of action involve the stimulation of mitochondria by the absorption of photons in cytochrome c oxidase, resulting in increased adenosine triphosphate production, reduced oxidative stress, anti-inflammatory effects, and increased focal cerebral blood flow

Official Title
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The Beneficial Effect of Low Level Laser Therapy Combined With Nasal Irradiation on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients

Conditions
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Alzheimer Disease, Cognitive Impairment, Mild

Intervention / Treatment
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* Device: low level laser therapy ( laser acupuncture combined with nasal laser irradiation)
* Other: aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sixty elderly patients aged from 65-75 y Body mass index (BMI) ranged from 30 to 34.9 kg/m2 Mild cognitive dysfunction (Montreal cognitive assessment scores from 19-25 Anemic The time between their diagnoses and participation in the study ranged from 6 months to 2 years Exclusion Criteria: Moderate to severe cognitive impairment History of neurological disease ,stroke or Cardiovascular disease History of nasal bleeding or fracture Known photo-sensitivity disorder Current active cancer or within one year of cancer treatment or remission Serious mental health illness that in the opinion of the investigator would preclude the subject from study participation Active infection, wound or other external trauma to the target area to receive the laser therapy Participation in a clinical study or other type of research in the past 30 days

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low level laser plus exercise<br>acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months | Device: low level laser therapy ( laser acupuncture combined with nasal laser irradiation)<br>* Cold Laser Therapy Watch (Laser Watch- 650 nm) combines acupuncture and nasal cavity for external blood irradiation. Laser watch with 10 laser beams - is applied to the left wrist. Nasal Probe with 2 laser beams - is applied to the nose cavity<br>Other: aerobic exercise<br>* 3 d/week for 45 to 60 minutes per session for 3 months. started by 40%-50% Heart Rate Reserve (determined by using a walking treadmill exercise test) during the first 6 weeks increasing gradually up to 50%-70% Heart Rate Reserve<br>|
| Placebo Comparator: sham laser plus exercise<br>placebo acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months | Device: low level laser therapy ( laser acupuncture combined with nasal laser irradiation)<br>* Cold Laser Therapy Watch (Laser Watch- 650 nm) combines acupuncture and nasal cavity for external blood irradiation. Laser watch with 10 laser beams - is applied to the left wrist. Nasal Probe with 2 laser beams - is applied to the nose cavity<br>Other: aerobic exercise<br>* 3 d/week for 45 to 60 minutes per session for 3 months. started by 40%-50% Heart Rate Reserve (determined by using a walking treadmill exercise test) during the first 6 weeks increasing gradually up to 50%-70% Heart Rate Reserve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of cognitive function | comparison of Montreal assessment scale scores before and after the intervention It range between 0 and 30. A score of 26 or over is considered to be normal. | 3 months | 
| changes of hemoglobin level | comparison of hemoglobin level for those anemic elderly before and after the intervention | 3 months | 
| changes of balance | comparison of berg balance scale scores before and after the intervention. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function | 3 months | 
| changes of quality of life | comparison of quality of life for Alzheimer disease scores before and after the intervention. It comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole) for a total score of 13-52 with higher scores indicating better quality of life | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of body mass index | comparison of body weight (kilogram) before and after the study in relation to height per meter square (weight and height will be combined to report BMI in kg/m^2) | 3 months | 
| changes of waist hip ratio | changes of waist hip ratio before and after the study | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low level laser, quality of life