Older PeopleNCT05532371
The Effect of Exercise on Cognitive Status in Older Adults
A study testing Aerobic exercise training combined with lower limb strengthening, Dual-task training combined with lower limb strengthening group (DG) and Aerobic exercise training combined with dual-task training and lower limb strengthening in people with Older People, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older People
- What is being tested?
- Aerobic exercise training combined with lower limb strengthening, Dual-task training combined with lower limb strengthening group (DG) and Aerobic exercise training combined with dual-task training and lower limb strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Not had a fall in the last six months.
- Older adults with an mini mental state examination score between18-23.
- Age ≥ 65years.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, 06500
About this study
Official title: 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.
Read the 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.
- Conditions
- Older People
- Being tested
- Aerobic exercise training combined with lower limb strengthening, Dual-task training combined with lower limb strengthening group (DG), Aerobic exercise training combined with dual-task training and lower limb strengthening, Only lower limb strengthening group (CG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise training combined with lower limb strengtheningOther
The participants performed aerobic exercise training and lower limb strengthening during this intervention.
Dual-task training combined with lower limb strengthening group (DG)Other
The participants performed dual-task training combined with lower limb strengthening during this intervention.
Aerobic exercise training combined with dual-task training and lower limb strengtheningOther
The participants performed aerobic exercise training combined with dual-task training and lower limb strengthening during this intervention.
Only lower limb strengthening group (CG)Other
The participants performed only lower limb strengthening group during this intervention.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise training combined with lower limb strengthening group (AG) | Experimental | Aerobic exercise training combined with lower limb strengthening. Receives: Other: Aerobic exercise training combined with lower limb strengthening |
| Dual-task training combined with lower limb strengthening group (DG) | Experimental | Dual-task training combined with lower limb strengthening. Receives: Other: Dual-task training combined with lower limb strengthening group (DG) |
| Aerobic exercise training combined with dual-task training and lower limb strengthening group (ADG) | Experimental | Aerobic exercise training combined with dual-task training and lower limb strengthening. Receives: Other: Aerobic exercise training combined with dual-task training and lower limb strengthening |
| Only lower limb strengthening group (CG) | Active comparator | Only lower limb strengthening. Receives: Other: Only lower limb strengthening group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
Cognitive status examination is applied with a simple test called "Mini-Mental State Examination".
Measured: 12 weeks
Commander Power Track 2 Manual Tester
Muscle strength strength is carried out with "Commander Power Track 2 Manual Tester".
Measured: 12 weeks
Timed Up and Go Test
Functional mobility is evaluated by Timed Up and Go Test.
Measured: 12 weeks
Single Leg Stance Test
Static balance is evaluated by Single Leg Stance Test
Measured: 12 weeks
Activities-specific Balance Confidence Scale
Balance Confidence is evaluated by Activities-specific Balance Confidence Scale.
Measured: 12 weeks
Six-Minute Walk Test
Exercise capacity is evaluated by Six-Minute Walk Test.
Measured: 12 weeks
Short Physical Performance Battery
Physical performance is evaluated by Short Physical Performance Battery.
Measured: 12 weeks
Hamilton Depression Rating Scale
Emotional status is evaluated by Hamilton Depression Rating Scale
Measured: 12 weeks
World Health Organization Quality of Life-Old module
Quality of life is evaluated by World Health Organization Quality of Life-Old module
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start30 Jan 2019
- Primary completion1 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Uysal, Muğla Sıtkı Koçman University
- Investigators
- İsmail Uysal, PhD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532371
- Sponsor's protocol ID
- Gazi University
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05532371
- Acronym / sponsor ID
- Gazi University
- Conditions
- Older People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training combined with lower limb strengthening group (AG) | Experimental | Other: Aerobic exercise training combined with lower limb strengtheningAerobic exercise training combined with lower limb strengthening. |
| Dual-task training combined with lower limb strengthening group (DG) | Experimental | Other: Dual-task training combined with lower limb strengthening group (DG)Dual-task training combined with lower limb strengthening. |
| Aerobic exercise training combined with dual-task training and lower limb strengthening group (ADG) | Experimental | Other: Aerobic exercise training combined with dual-task training and lower limb strengtheningAerobic exercise training combined with dual-task training and lower limb strengthening. |
| Only lower limb strengthening group (CG) | Active comparator | Other: Only lower limb strengthening group (CG)Only lower limb strengthening. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Not had a fall in the last six months.
- Older adults with an mini mental state examination score between18-23.
- Age ≥ 65years.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise training combined with lower limb strengtheningThe participants performed aerobic exercise training and lower limb strengthening during this intervention. | Other | Aerobic exercise training combined with lower limb strengthening group (AG) |
| Dual-task training combined with lower limb strengthening group (DG)The participants performed dual-task training combined with lower limb strengthening during this intervention. | Other | Dual-task training combined with lower limb strengthening group (DG) |
| Aerobic exercise training combined with dual-task training and lower limb strengtheningThe participants performed aerobic exercise training combined with dual-task training and lower limb strengthening during this intervention. | Other | Aerobic exercise training combined with dual-task training and lower limb strengthening group (ADG) |
| Only lower limb strengthening group (CG)The participants performed only lower limb strengthening group during this intervention. | Other | Only lower limb strengthening group (CG) |
Primary outcome
Mini-Mental State Examination
Time frame: 12 weeks
Cognitive status examination is applied with a simple test called "Mini-Mental State Examination".
Commander Power Track 2 Manual Tester
Time frame: 12 weeks
Muscle strength strength is carried out with "Commander Power Track 2 Manual Tester".
Timed Up and Go Test
Time frame: 12 weeks
Functional mobility is evaluated by Timed Up and Go Test.
Single Leg Stance Test
Time frame: 12 weeks
Static balance is evaluated by Single Leg Stance Test
Activities-specific Balance Confidence Scale
Time frame: 12 weeks
Balance Confidence is evaluated by Activities-specific Balance Confidence Scale.
Six-Minute Walk Test
Time frame: 12 weeks
Exercise capacity is evaluated by Six-Minute Walk Test.
Short Physical Performance Battery
Time frame: 12 weeks
Physical performance is evaluated by Short Physical Performance Battery.
Hamilton Depression Rating Scale
Time frame: 12 weeks
Emotional status is evaluated by Hamilton Depression Rating Scale
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İsmail Uysal, PhD principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training combined with lower limb strengthening, Dual-task training combined with lower limb strengthening group (DG) and Aerobic exercise training combined with dual-task training and lower limb strengthening in people with Older People, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.