Effect of Physical-Cognitive Training in Older Adults
ConditionOlder Adults, Balance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorMedipol University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Physical-Cognitive Training
Other interventionParticipants 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.
Conventional Balance Training
Other interventionParticipants will receive an 8-week conventional balance training program. Sessions will be conducted three times per week, each lasting one hour.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Physical-Cognitive Training GroupExperimental treatment 1 intervention
Group B: Conventional Balance Training GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 8 weeks2
Montreal Cognitive Assessment
A brief cognitive screening tool evaluating memory, attention, language, visuospatial skills, and executive function. Scores below 26 suggest possible cognitive impairment.
Time frame
From enrollment to the end of treatment at 8 weeks3
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.
Time frame
From enrollment to the end of treatment at 8 weeks4
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.
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Katz Index of Independence in Activities of Daily Living
Evaluates independence in six daily activities: bathing, dressing, toileting, transferring, continence, and feeding. Higher scores indicate greater independence.
Time frame
From enrollment to the end of treatment at 8 weeks2
Lawton Instrumental Activities of Daily Living Scale
Assesses more complex daily living skills. Measures ability to perform tasks such as using the telephone, shopping, preparing meals, housekeeping, laundry, transportation, medication management, and handling finances. Higher scores indicate greater functional ability, and score is between 0-17.
Time frame
From enrollment to the end of treatment at 8 weeks3
Pittsburgh Sleep Quality Index
Assess sleep quality and disturbances. A self-reported questionnaire evaluating sleep quality over the past month, including components such as sleep duration, latency, efficiency, disturbances, and daytime dysfunction. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov