NCT04271943

Brief Summary

With the positive contribution of technological developments to living conditions and improvements in health services, the ratio of elderly population to general population is increasing all over the world. Cognitive decline and deterioration are among the most feared in the elderly and have high costs. Dementia is one of the most common diseases of old age. The prevalence of dementia increases in societies where the elderly population increases. At first, while memory is impaired, functions such as attention, language, visuospatial skills, perception and problem solving are impaired. It is estimated that the number of people living with dementia in the world is now 35.6 million, and it will reach 131.5 million by 2050. Since there is no treatment or effective disease modifying drug to treat the most common types of dementia to date, the research should focus on the development and implementation of non-pharmacological interventions as an alternative or as an additional treatment. In the field of rehabilitation; regular physical exercises, such as walking, strength and balance exercises, dance and chair exercises, can improve physical and cognitive functions such as fitness, daily functions, executive functions, language and working memory in people living with dementia. Movement activation groups such as psychomotor group therapy have been found to have a positive effect on the social behavior of people living with emotional and dementia. Recent meta-analyzes have shown that physical exercise can help maintain and even improve cognitive function in healthy elderly adults. There is evidence that exercise increases the volume of the prefrontal cortex and anterior hippocampus and may increase neurogenesis. Computer-based cognitive education has received great attention as a safe, relatively inexpensive and scalable intervention aimed at protecting cognition in older adults. It is an innovative way of exercising in a virtual reality or gaming environment that can help dementia patients to be physically active while being cognitively stimulated. In our study, it was seen that the number of studies on this subject is small and the devices used in the studies were made with game consoles and there were problems in working with game consoles in patients with dementia. Within the framework of all this information, we aimed to investigate the cognitive effects of physical activity and their differences according to each other with computer assisted exergame study written for rehabilitation in demented individuals; We aim to increase cognitive functions and increase quality of life and reaction time of exergamine dementia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

5.7 years

First QC Date

February 14, 2020

Last Update Submit

May 30, 2024

Conditions

Keywords

DEMENTIACOMPUTER BASED EXERCISECOGNITIVE EXERCISE

Outcome Measures

Primary Outcomes (2)

  • MONTREAL COGNITIVE ASSESSMENT

    The MoCA is a screening tool for individuals with mild cognitive dysfunction. The test assesses 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

    10 MINUTE

  • STROOP TEST

    He Stroop test Is a test that is used in the field of psychology and shows the interference that can occur in a task that requires selective attention to be performed. The selective attention is the one that allows us to be able to attend to two different stimuli at the same time to carry out an action and to discriminate between them to react to what we consider important.

    10 MINUTE

Secondary Outcomes (2)

  • NOTTINGHAM HEALTH PROFILE

    5 MINUTE

  • DIGIT SPAN TEST

    5 MINUTE

Study Arms (2)

COMPUTER BASED EXERCISES

ACTIVE COMPARATOR
Behavioral: Computer Based Exercises

AEROBIC EXERCISES

ACTIVE COMPARATOR
Dietary Supplement: Aerobic Exercises

Interventions

For 8 weeks 3 days a week for 45 minutes See-ME Virtual Rehabilitation system with the physical therapist will perform cognitive and physical activity exercises

COMPUTER BASED EXERCISES
Aerobic ExercisesDIETARY_SUPPLEMENT

For 8 weeks 3 days a week exercise bike with 5 min warm-up 35 min constant speed exercise 5 min cooling, a total of 45 min prescribed by the physiotherapist to the maximum heart rate will do aerobic exercise work. Cardiac values will also be monitored throughout the session

AEROBIC EXERCISES

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • YEARS OLD OR OLDER PEPOPLE WITH DEMENTIA
  • BETWEEN 11-25 MINI-MENTAL STATE EXAMINITATION SCORE

You may not qualify if:

  • COOPERATION PROBLEM
  • UNSTABLE MEDICAL CONDITION
  • PRESENCE OF BIPOLAR DISORDER OR PSYCHOTIC DISORDER
  • ANY CO-MORBIDITY THAT PREVENTS EXERCISE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guvencetin

Istanbul, Sisli, 34365, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physichal therapist MsC

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 17, 2020

Study Start

April 20, 2019

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
Time Frame
on 2021

Locations