Effect of Health Promotion Model-Based Oculomotor Exercise Program on Sleep Quality in Older Adults

November 23, 2025 updated by: Hande Sabandüzen, Istanbul University - Cerrahpasa

Investigation of the Effect of Health Promotion Model Based Oculomotor Exercise Program on Sleep Quality in Elderly Living in a Nursing Home: A Randomized Controlled Trial

The goal of this clinical trial is to investigate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home.

The main questions it aims to answer are:

Does the Health Promotion Model-based oculomotor exercise program improve sleep quality in older adults living in a nursing home? Does participation in the program enhance self-efficacy and promote better health behaviors related to sleep?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial aims to evaluate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home. Participants in the experimental group will receive an approximately 3-month structured intervention integrating oculomotor exercises and motivational interviewing techniques, while the control group will receive no intervention and continue with their usual daily routines.

The intervention is designed according to the components of the Health Promotion Model, targeting self-efficacy and behavior change processes. During the first meeting, participants complete baseline assessments, including the Personal Information Form, Sleep Beliefs Scale, Stages of Change Inventory, DSM-5 Sleep Disorder Scale, and Pittsburgh Sleep Quality Index (PSQI). Over four weeks, participants in the experimental group perform oculomotor exercises three times a week (Monday, Wednesday, Friday) and attend weekly motivational interviewing sessions focusing on awareness, perceived benefits, self-efficacy, decision balance, empowerment, and commitment to behavior. Weekly DSM-5 Sleep Disorder assessments are also conducted.

Follow-up sessions continue during the second and third months to support maintenance of behavior change, with monthly evaluations using the PSQI and Stages of Change Inventory. Sleep diaries are used throughout to monitor participants' sleep patterns. The primary outcome is sleep quality, and secondary outcomes include self-efficacy and behavioral stage of change.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 65 years or older
  • Residing in the nursing home for at least 6 months
  • Scoring 4 or above on the Mini-Cog test
  • Pittsburgh Sleep Quality Index (PSQI) score ≥ 5 (indicating poor sleep quality)
  • No diagnosis of psychiatric disorders such as depression, bipolar disorder, or schizophrenia
  • No diagnosis of serious sleep disorders such as sleep apnea or narcolepsy
  • No medical condition causing frequent nocturnal awakenings, such as nocturia
  • Not using antipsychotic or other medications that may affect sleep quality
  • Having chronic diseases (e.g., diabetes mellitus, hypertension, coronary artery disease) that are controlled with pharmacological treatment
  • No communication problems

Exclusion Criteria:

  • Older adults unable to perform self-care independently
  • Older adults with dizziness or balance problems
  • Participants who are hospitalized for any reason during the follow-up or exercise sessions will be excluded from the study

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
Participants in this group will receive a structured oculomotor exercise program designed according to the Health Promotion Model. The program includes oculomotor exercises performed three times a week and weekly motivational interviewing sessions to enhance self-efficacy and adherence. Sleep quality and behavioral change outcomes will be assessed at baseline and post-intervention.
Behavioral: Oculomotor Exercise Program

This intervention is a structured oculomotor exercise program based on the Health Promotion Model, developed to improve sleep quality among older adults living in a nursing home. The program focuses on enhancing visual-motor coordination and relaxation through systematic eye movement exercises.

Participants in the experimental group perform oculomotor exercises three times per week for four consecutive weeks under researcher supervision. The program includes educational support and brief motivational guidance to encourage adherence and consistency. Follow-up sessions are conducted during the following two months to monitor sleep patterns and maintain behavioral improvement.

This intervention differs from traditional exercise programs by targeting the oculomotor system and incorporating health promotion principles to support better sleep and overall well-being in older adults.
No Intervention: Control Group
Participants in this group will not receive any intervention. They will continue their usual daily activities and will be evaluated using the same measurement tools and time points as the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: Baseline, 4 weeks, 2 and 3 months after the intervention
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality, sleep latency, duration, and disturbances over the previous month. Higher scores indicate poorer sleep quality.
Baseline, 4 weeks, 2 and 3 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage of Behavioral Change
Time Frame: Baseline, 4 weeks, 2 and 3 months after the intervention
Behavioral change related to sleep habits will be assessed using the Stages of Change Inventory. The scale evaluates participants' progression through different stages of adopting and maintaining healthy sleep behaviors.
Baseline, 4 weeks, 2 and 3 months after the intervention

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa

Investigators

  • Principal Investigator: Hande sabandüzen, PhD Candidate, Istanbul University-Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

January 5, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUC_LEE_HS_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to privacy and ethical restrictions

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.

Clinical Trials on Sleep Quality

Clinical Trials on Oculomotor Exercise Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe