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

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

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Cognitive Impairment, Mild
• Intervention / Treatment: Device: low level laser therapy ( laser acupuncture combined with nasal laser irradiation); Other: aerobic exercise

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 11432
      • Cairo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: low level laser plus exercise; 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); 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; Other: aerobic exercise; 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
Placebo Comparator: sham laser plus exercise; 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); 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; Other: aerobic exercise; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ebtesam Nabil, doctoral, Cairo University

Publications and helpful links

General Publications

• Nagy EN, Ali AY, Behiry ME, Naguib MM, Elsayed MM. Impact of Combined Photo-Biomodulation and Aerobic Exercise on Cognitive Function and Quality-of-Life in Elderly Alzheimer Patients with Anemia: A Randomized Clinical Trial. Int J Gen Med. 2021 Jan 14;14:141-152. doi: 10.2147/IJGM.S280559. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; low level laser
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: P.T.REC/012/0027772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: after 2 years of study completion till 3 months after
• IPD Sharing Access Criteria: students and scientific researchers will be allowed to access
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No