NCT06553690

Brief Summary

This clinical trial aims to evaluate the impact of Brain Gym Therapy on the quality of sleep among elderly individuals attending healthcare facilities. The study will explore whether this non-pharmacological intervention can improve sleep quality, which is often compromised in the elderly population due to various health conditions and age-related changes. Participants will undergo Brain Gym Therapy sessions over a specified period, and their sleep quality will be assessed using validated sleep measurement tools. The findings may provide insights into alternative methods for enhancing sleep in older adults.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 11, 2024

Last Update Submit

August 11, 2024

Conditions

Keywords

Brain Gym TherapySleep QualityCognitive ExerciseNon-Pharmacological InterventionInsomnia in Elderly

Outcome Measures

Primary Outcomes (1)

  • Improvement in Sleep Quality

    The primary outcome measure will assess the improvement in sleep quality among elderly participants who undergo Brain Gym Therapy compared to those receiving standard care. Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a validated and widely used instrument that measures various aspects of sleep including duration, latency, efficiency, disturbances, and subjective sleep quality. The PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

    Baseline, Week 4 (post-intervention), and Week 8 (follow-up)

Study Arms (2)

Participants receiving Brain Gym Therapy.

EXPERIMENTAL

Participants in this arm will undergo Brain Gym Therapy, which consists of a series of structured physical exercises designed to enhance cognitive function and promote relaxation.

Other: Brain Gym Therapy

Participants receiving standard care without Brain Gym Therapy

NO INTERVENTION

standered care

Interventions

Brain Gym Therapy is a structured program of physical movements designed to enhance cognitive function, reduce stress, and promote relaxation. The therapy is based on the principle that specific physical activities can stimulate brain function and improve overall mental and physical well-being.

Also known as: non
Participants receiving Brain Gym Therapy.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly individuals aged 60 years and above. Attending healthcare facilities and able to participate in the study. Experiencing issues with sleep quality, as determined by a score of 5 or higher on the Pittsburgh Sleep Quality Index (PSQI).
  • Willing and able to provide informed consent. Physically capable of performing gentle physical exercises as part of Brain Gym Therapy

You may not qualify if:

  • Severe cognitive impairment or dementia that would impede understanding or participation in the intervention.
  • Current participation in another sleep intervention study. Presence of severe medical conditions that contraindicate physical activity (e.g., severe cardiovascular disease, musculoskeletal disorders).
  • Use of sleep medications that could confound the study results. Recent history (within the past 6 months) of major psychiatric disorders, including severe depression or anxiety.
  • Any condition that, in the opinion of the investigators, would make participation unsafe or not in the best interest of the participant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alanazi MA, Shaban M, Zaky ME. Impact of brain gym therapy on quality of sleep among older adults attending health care facilities. Geriatr Nurs. 2025 Jul-Aug;64:103431. doi: 10.1016/j.gerinurse.2025.103431. Epub 2025 Jun 27.

MeSH Terms

Conditions

Sleep Wake DisordersSleep Initiation and Maintenance DisordersCognition DisordersFrailty

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomniasNeurocognitive DisordersPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 14, 2024

Study Start

August 15, 2024

Primary Completion

October 11, 2024

Study Completion

October 12, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08