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

NCT ID: NCT04496778

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2020-08-01

Brief Summary

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

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

Conditions

Alzheimer Disease; Cognitive Impairment, Mild

Study Design

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

Study Groups

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

Group Type: ACTIVE_COMPARATOR

low level laser therapy ( laser acupuncture combined with nasal laser irradiation)

Intervention Type: DEVICE

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

aerobic exercise

Intervention Type: OTHER

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

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

Group Type: PLACEBO_COMPARATOR

low level laser therapy ( laser acupuncture combined with nasal laser irradiation)

Intervention Type: DEVICE

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

aerobic exercise

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ebtesam Nabil

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebtesam Nabil, doctoral

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo

Giza, Dokki, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 33469351 (View on PubMed)

Other Identifiers

P.T.REC/012/0027772

Identifier Type: -

Identifier Source: org_study_id