Low Level Laser Therapy Impact on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients
Primary Purpose
Alzheimer Disease, Cognitive Impairment, Mild
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low level laser therapy ( laser acupuncture combined with nasal laser irradiation)
aerobic exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease focused on measuring low level laser, quality of life
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
Sites / Locations
- Cairo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
low level laser plus exercise
sham laser plus exercise
Arm Description
acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months
placebo acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months
Outcomes
Primary Outcome Measures
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.
changes of hemoglobin level
comparison of hemoglobin level for those anemic elderly before and after the intervention
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
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
Secondary Outcome Measures
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)
changes of waist hip ratio
changes of waist hip ratio before and after the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04496778
Brief Title
Low Level Laser Therapy Impact on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients
Official Title
The Beneficial Effect of Low Level Laser Therapy Combined With Nasal Irradiation on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Impairment, Mild
Keywords
low level laser, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low level laser plus exercise
Arm Type
Active Comparator
Arm Description
acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months
Arm Title
sham laser plus exercise
Arm Type
Placebo Comparator
Arm Description
placebo acupuncture low level laser combined with nasal laser irradiation in addition to aerobic exercise 3 times per week for 3 months
Intervention Type
Device
Intervention Name(s)
low level laser therapy ( laser acupuncture combined with nasal laser irradiation)
Intervention Description
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
Other
Intervention Name(s)
aerobic exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
change of cognitive function
Description
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.
Time Frame
3 months
Title
changes of hemoglobin level
Description
comparison of hemoglobin level for those anemic elderly before and after the intervention
Time Frame
3 months
Title
changes of balance
Description
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
Time Frame
3 months
Title
changes of quality of life
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
changes of body mass index
Description
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)
Time Frame
3 months
Title
changes of waist hip ratio
Description
changes of waist hip ratio before and after the study
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebtesam Nabil, doctoral
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo
City
Giza
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share 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 URL
http://Scholar.cu.edu.eg/p_t
Citations:
PubMed Identifier
33469351
Citation
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.
Results Reference
derived
Learn more about this trial
Low Level Laser Therapy Impact on Cognitive Function and Quality of Life in Alzheimer Anemic Elderly Patients
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