Brain Gym Therapy on Quality of Sleep Among Elderly People

NCT ID: NCT06553690

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2024-10-12

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.

Detailed Description

This study investigates the effects of Brain Gym Therapy on the quality of sleep among elderly individuals who are receiving care at healthcare facilities. Brain Gym Therapy, a series of physical activities designed to enhance cognitive functions, has been hypothesized to positively influence sleep patterns by reducing stress, improving relaxation, and enhancing overall mental well-being.

The study will employ a randomized controlled trial design, with participants being randomly assigned to either an intervention group receiving Brain Gym Therapy or a control group receiving standard care without the therapy. The intervention will consist of structured Brain Gym exercises conducted by trained practitioners, focusing on movements that are believed to stimulate brain function and promote relaxation.

Participants will be elderly individuals aged 65 and above, attending healthcare facilities, and experiencing issues with sleep quality. Exclusion criteria will include individuals with severe cognitive impairments, those currently undergoing other sleep interventions, or those with contraindications to physical activity.

The primary outcome measure will be the quality of sleep, assessed using validated sleep questionnaires such as the Pittsburgh Sleep Quality Index (PSQI), alongside secondary outcomes including sleep latency, duration, and efficiency. Data will be collected at baseline, mid-intervention, and post-intervention, with follow-up assessments to determine the sustainability of any observed effects.

The study aims to contribute to the growing body of evidence supporting non-pharmacological interventions for sleep improvement in the elderly, potentially offering a viable alternative to medication for managing sleep disturbances in this population. Ethical approval has been obtained, and all participants will provide informed consent before participation

Conditions

Sleep Disorder; Insomnia; Cognitive Function Abnormal; Old Age; Debility; Brain Gym Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Participants receiving Brain Gym Therapy.

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.

Group Type: EXPERIMENTAL

Brain Gym Therapy

Intervention Type: OTHER

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.

Participants receiving standard care without Brain Gym Therapy

standered care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brain Gym Therapy

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.

Intervention Type: OTHER

Other Intervention Names

non

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Shaban

dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 40580820 (View on PubMed)

Other Identifiers

HAP-13-S-001

Identifier Type: OTHER

Identifier Source: secondary_id

braingym

Identifier Type: -

Identifier Source: org_study_id