Effect of Physical-Cognitive Training in Older Adults

NCT07199426 | Recruiting

• 1 other identifier: MU-FTR-GBB-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The study compares the impact of physical-cognitive exercises using Blazepod device versus conventional balance training on multiple outcomes in older adults aged 70 and above. Participants receive an 8-week intervention, three sessions per week for both groups. Outcome measures include balance assessments, fear of falling scales, activity of daily living performance, sleep quality questionnaires, reaction time tests, and cognitive assessments. The study aims to determine whether physical-cognitive training provides additional benefits compared to conventional balance exercises.

Conditions

Older Adults, Balance

Outcome Measures

Primary Outcomes (7)

• Standartized Mini Mental Test

  It is a test used to assess cognitive impairment and changes, scored out of 30 points, with scores below 24 indicating potential dementia.

  From enrollment to the end of treatment at 8 weeks

• Montreal Cognitive Assessment

  A brief cognitive screening tool evaluating memory, attention, language, visuospatial skills, and executive function. Scores below 26 suggest possible cognitive impairment.

  From enrollment to the end of treatment at 8 weeks

• Fullerton Advanced Balance Scale

  A clinical balance assessment consisting of 10 tasks that test static and dynamic balance, anticipatory postural adjustments, and sensory integration. Total score is changed 0-40 and higher scores indicated better balance.

  From enrollment to the end of treatment at 8 weeks

• Functional Reach Test

  Assesses the maximal distance a person can reach forward beyond arm's length while maintaining a fixed base of support. Measures dynamic balance and risk of falling.

  From enrollment to the end of treatment at 8 weeks

• Timed Up and Go Test

  Measures the time taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Evaluates mobility, balance and fall risk.

  From enrollment to the end of treatment at 8 weeks

• Modified Falls Efficacy Scale

  Assesses fear of falling and confidence in performing daily activities. A self-reported questionnaire measuring perceived confidence in avoiding falls during various daily activities.

  From enrollment to the end of treatment at 8 weeks

• Deary-Liewald Reaction Time Task

  Evaluates simple and choice reaction time. A computerized test measuring the speed of cognitive-motor responses to visual stimuli.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (3)

• Katz Index of Independence in Activities of Daily Living

  From enrollment to the end of treatment at 8 weeks

• Lawton Instrumental Activities of Daily Living Scale

  From enrollment to the end of treatment at 8 weeks

• Pittsburgh Sleep Quality Index

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Physical-Cognitive Training Group

EXPERIMENTAL

Blazepod-based physical-cognitive training (8 weeks, 3 sessions/week)

Other: Physical-Cognitive Training

Conventional Balance Training Group

ACTIVE COMPARATOR

Conventional balance training (8 weeks, 3 sessions/week)

Other: Conventional Balance Training

Interventions

Physical-Cognitive Training OTHER

Participants will receive an 8-week physical-cognitive training program using the Blazepod device, consisting of exercises targeting both balance and cognitive skills. Sessions will be conducted three times per week, each lasting one hour.

Physical-Cognitive Training Group

Conventional Balance Training OTHER

Participants will receive an 8-week conventional balance training program. Sessions will be conducted three times per week, each lasting one hour.

Conventional Balance Training Group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Score of 24 or higher on the Standardized Mini-Mental State Examination (MMSE)
• Ability to walk independently without assistance
• Willingness to provide written informed consent

You may not qualify if:

• Participation in another clinical study during the study period
• Presence of neurological or psychiatric diagnoses
• Conditions that impair walking or mobility
• Uncontrolled hypertension or cardiovascular disease

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Gözde Baş Başer

CONTACT

+905385460124; gozde.bas@std.medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)