NCT07466615

Brief Summary

This study aims to investigate the effects of sensory integration training on cognitive functions, quality of life, and social participation in older adults with Mild Cognitive Impairment (MCI)

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 5, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

Mild Cognitive ImpairmentSensory ProcessingSensory Integration TrainingCognitive Function

Outcome Measures

Primary Outcomes (1)

  • Quick Mild Cognitive Impairment Screen - Turkish Version

    Quick Mild Cognitive Impairment Screen - Turkish Version is a cognitive assessment tool consisting of six sub-headings covering at least five cognitive domains. The sub-headings and the cognitive domains they assess are defined as follows: 1. Orientation: (Questioning the country, year, month, day, and date - approx. 1 minute - 10 points) 2. Registration: (Working memory; repeating 5 given words - 30 seconds - 5 points) 3. Clock Drawing: (Visuospatial; drawing a clock within 1 minute - 15 points) 4. Delayed Recall: (Episodic memory; recalling the 5 previously mentioned words - 30 seconds - 20 points) 5. Verbal Fluency: (Semantic memory/language; naming animals within 1 minute - 20 points) 6. Logical Memory: (Episodic memory; repeating a short story - 1 minute - 30 points) Scoring and Interpretation The test is evaluated out of a total of 100 points, where higher scores indicate better cognitive status. A score of 62 points or below indicates cognitive impairment.

    6 months

Secondary Outcomes (2)

  • World Health Organization Quality of Life - Older Adults Module

    6 months

  • Lubbes Social Network Scale-6

    6 months

Study Arms (2)

Aerobic Exercise +Sensory Integration Training

EXPERIMENTAL
Other: Aerobic ExerciseOther: Sensory Integration Training

Aerobic Exercise

ACTIVE COMPARATOR
Other: Aerobic Exercise

Interventions

The aerobic exercise intervention consists of a 12-week outdoor walking program, performed twice weekly for 45 minutes per session at a moderate intensity, targeting a score of 12-14 on the Borg Rating of Perceived Exertion (RPE) scale

Aerobic ExerciseAerobic Exercise +Sensory Integration Training

The program includes activities that stimulate three main senses: vestibular (balance and movement), proprioceptive (body awareness), and tactile (touch). These exercises are designed to help the brain organize sensory signals more effectively to improve daily functions and cognitive performance.

Aerobic Exercise +Sensory Integration Training

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being between 65 and 85 years of age
  • Having a Montreal Cognitive Assessment (MoCA) score between 18 and 25, indicating mild cognitive impairment
  • Being in stable medical health, with no history of severe neurological or psychiatric disorders
  • Voluntary participation

You may not qualify if:

  • Clinical diagnosis of dementia or having moderate-to-severe cognitive impairment
  • Severe visual or hearing loss to a degree that prevents effective communication or participation in assessments
  • Presence of severe sensory, motor, or physical disabilities that render the intervention (e.g., walking or sensory training) impossible to perform
  • Acute medical conditions or having unstable chronic diseases that may pose a risk during physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isparta Şehir Hastanesi

Isparta, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled trial (RCT) using a pretest-posttest experimental design"
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
STUDENT

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 12, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations