Brain Gym Therapy on Quality of Sleep Among Elderly People (BG/E)

August 11, 2024 updated by: Mostafa Shaban, Cairo University

Impact of Brain Gym Therapy on Quality of Sleep Among Elderly People Attending Health Care Facilities

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • non
No Intervention: Participants receiving standard care without Brain Gym Therapy
standered care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Sleep Quality
Time Frame: Baseline, Week 4 (post-intervention), and Week 8 (follow-up)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

October 11, 2024

Study Completion (Estimated)

October 12, 2024

Study Registration Dates

First Submitted

August 11, 2024

First Submitted That Met QC Criteria

August 11, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • braingym
  • HAP-13-S-001 (Other Identifier: Jouf university)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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