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

NCT04496778 | Completed DMC

• 1 other identifier: P.T.REC/012/0027772
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer Disease; Cognitive Impairment, Mild

Keywords

low level laser; quality of life

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• changes of body mass index

  3 months

• changes of waist hip ratio

  3 months

Study Arms (2)

low level laser plus exercise

ACTIVE COMPARATOR

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); Other: aerobic exercise

sham laser plus exercise

PLACEBO COMPARATOR

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); Other: aerobic exercise

Interventions

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

low level laser plus exercise; sham laser plus exercise

aerobic exercise 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

low level laser plus exercise; sham laser plus exercise

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo

Giza, Dokki, 11432, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33469351 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Low-Level Light Therapy; Exercise

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ebtesam Nabil, doctoral

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 3, 2020
• Study Start: January 3, 2020
• Primary Completion: July 28, 2020
• Study Completion: August 1, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after 2 years of study completion till 3 months after
• Access Criteria: students and scientific researchers will be allowed to access

Locations

EG (1)