- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05532371
The Effect of Exercise on Cognitive Status in Older Adults
September 4, 2022 updated by: Ismail Uysal, Muğla Sıtkı Koçman University
Is Aerobic and Dual-task Training Combination the Most Effective Exercise Combination to Improve the Cognitive Status and Physical Function in Older Adults With Mild Cognitive Decline
The purpose of the study is to demonstrate the effectiveness of the different combinations of exercises on the cognitive status of older adults with cognitive decline.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is planned to examine the effects of combined exercise on cognitive status, lower extremity muscle strength, mobility, physical performance, mood and quality of life in older adults with Mild Cognitive Impairment.
Aerobic exercise training and lower limb (extremity) strengthening exercises were applied to the first group, dual-task training and lower limb strengthening exercises were applied to the second group, and aerobic exercise training, dual-task training and lower limb strengthening exercises were applied to the third group.
Study Type
Interventional
Enrollment (Actual)
48
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 Locations
-
-
-
Ankara, Turkey, 06500
- Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Not had a fall in the last six months.
- Older adults with an mini mental state examination score between18-23.
- Age ≥ 65years.
Exclusion Criteria:
- having central nervous system pathology that will affect balance
- diagnosed with vestibular pathology,
- having deformities in the waist, hip, and knee joints,
- having lower extremity amputation,
- with lower extremity operation history,
- malignancy affecting the lower extremity,
- having moderate and severe congenital heart disease, coronary heart disease and cerebrovascular disease,
- participants who cannot cooperate,
- participants who use an assistive walking device,
- participants having vision problems.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic exercise training combined with lower limb strengthening group (AG)
Aerobic exercise training combined with lower limb strengthening.
|
The participants performed aerobic exercise training and lower limb strengthening during this intervention.
|
|
Experimental: Dual-task training combined with lower limb strengthening group (DG)
Dual-task training combined with lower limb strengthening.
|
The participants performed dual-task training combined with lower limb strengthening during this intervention.
|
|
Experimental: Aerobic exercise training combined with dual-task training and lower limb strengthening group (ADG)
Aerobic exercise training combined with dual-task training and lower limb strengthening.
|
The participants performed aerobic exercise training combined with dual-task training and lower limb strengthening during this intervention.
|
|
Active Comparator: Only lower limb strengthening group (CG)
Only lower limb strengthening.
|
The participants performed only lower limb strengthening group during this intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Mental State Examination
Time Frame: 12 weeks
|
Cognitive status examination is applied with a simple test called "Mini-Mental State Examination".
|
12 weeks
|
|
Commander Power Track 2 Manual Tester
Time Frame: 12 weeks
|
Muscle strength strength is carried out with "Commander Power Track 2 Manual Tester".
|
12 weeks
|
|
Timed Up and Go Test
Time Frame: 12 weeks
|
Functional mobility is evaluated by Timed Up and Go Test.
|
12 weeks
|
|
Single Leg Stance Test
Time Frame: 12 weeks
|
Static balance is evaluated by Single Leg Stance Test
|
12 weeks
|
|
Activities-specific Balance Confidence Scale
Time Frame: 12 weeks
|
Balance Confidence is evaluated by Activities-specific Balance Confidence Scale.
|
12 weeks
|
|
Six-Minute Walk Test
Time Frame: 12 weeks
|
Exercise capacity is evaluated by Six-Minute Walk Test.
|
12 weeks
|
|
Short Physical Performance Battery
Time Frame: 12 weeks
|
Physical performance is evaluated by Short Physical Performance Battery.
|
12 weeks
|
|
Hamilton Depression Rating Scale
Time Frame: 12 weeks
|
Emotional status is evaluated by Hamilton Depression Rating Scale
|
12 weeks
|
|
World Health Organization Quality of Life-Old module
Time Frame: 12 weeks
|
Quality of life is evaluated by World Health Organization Quality of Life-Old module
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: İsmail Uysal, PhD, Muğla Sıtkı Koçman University
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 (Actual)
January 30, 2019
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
September 4, 2022
First Submitted That Met QC Criteria
September 4, 2022
First Posted (Actual)
September 8, 2022
Study Record Updates
Last Update Posted (Actual)
September 8, 2022
Last Update Submitted That Met QC Criteria
September 4, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Gazi University (Other Identifier: Research Projects Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.