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Cognitive ImpairmentNCT06029920

Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment

A study testing Overground Walking in people with Cognitive Impairment and Aging, run by Universitas Padjadjaran at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research is to investigate the impact of overground walking as a part of a rehabilitation program on the increase in Brain-derived neurotrophic factor (BDNF) levels, decrease in IL-6 levels, decrease in hs-CRP levels, improvement in cognitive function, and enhancement of quality of life (QOL) in… Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Impairment, Aging
What is being tested?
Overground Walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteIndonesia
Study dates
5 Sep 2023to 31 Oct 2023
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 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Mild cognitive impairment (MoCA INA Score 19-25 out of 30
  • Barthel Index Score 20
  • Geriatric Depression Scale Score ≤ 5
  • Timed Up and Go Test < 15 seconds)
  • Capable of comprehending verbal and written instructions
  • Capable of walking unassisted

Who cannot join

  • The presence of hearing impairment that could hinder the subject from receiving verbal instructions,
  • The presence of uncorrected visual impairment
  • Having musculoskeletal disorders
  • Receiving other rehabilitation programs,
  • Presence of diseases causing cognitive impairment
  • Severe joint diseases such as osteoarthritis and rheumatoid arthritis that may worsen during exercise or could pose difficulties in carrying out the exercise program,
  • Severe cardiovascular diseases as diagnosed by a Cardiologist

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Nursing Home

    Bandung, West Java

Other trials in Indonesia

About this study

Official title: The Effect of Overground Walking on the Increase of Brain-Derived Neurotrophic Factor Levels, IL-6, HS-CRP, Cognitive Function, and Quality of Life in the Elderly

The purpose of this research is to investigate the impact of overground walking as a part of a rehabilitation program on the increase in Brain-derived neurotrophic factor (BDNF) levels, decrease in IL-6 levels, decrease in hs-CRP levels, improvement in cognitive function, and enhancement of quality of life (QOL) in older people with mild cognitive impairment. These findings are anticipated to contribute to the efforts to elevate BDNF levels, cognitive function, and QOL while reducing IL-6 and hsCRP levels in the elderly with mild cognitive impairment.

Read the detailed description

This research employs a quasi-experimental research design using a Pretest-Posttest Design approach. The Pretest-Posttest method is executed by assessing before and after the intervention within the same group.

All research subjects receive the same treatment, which involves participating in an overground walking program on a flat surface. The selected research subjects are provided with an explanation of the research's objectives and benefits and the exercise and examination procedures, then sign the informed consent.

Research subjects are instructed to walk on a flat surface for a distance of 15 meters, with a duration of 20 minutes, increasing by 5 minutes each week until the target heart rate is achieved during the exercise. After an 8-week post-intervention period, research subjects will undergo a follow-up examination.

Being tested
Overground Walking
Keywords
Exercise, Rehabilitation
Medical subject headings
Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Overground WalkingOther

    Walk on a flat surface for a distance of 15 meters, with a duration of 20 minutes, increasing by 5 minutes each week until the target heart rate is achieved during the exercise, for 8 weeks.

Study groups in NCT06029920
Study groupRoleWhat they receive
SubjectsExperimentalNot described
Receives: Other: Overground Walking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BDNF

    Brain-derived neurotrophic factor level

    Measured: 8 weeks

  2. IL6

    Interleukin-6 level

    Measured: 8 weeks

  3. hsCRP

    hs-CRP level

    Measured: 8 weeks

  4. MoCAINA

    MONTREAL COGNITIVE ASSESSMENT INDONESIA

    Measured: 8 weeks

  5. ADQOL

    Alzheimer disease Quality of Life

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start5 Sep 2023
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029920
Sponsor's protocol ID
IKFR.2023.08.01
Status last verified
Nov 2023
First submitted
1 Sep 2023
Last updated
7 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Amieva H, Letenneur L, Dartigues JF, Rouch-Leroyer I, Sourgen C, D'Alchee-Biree F, Dib M, Barberger-Gateau P, Orgogozo JM, Fabrigoule C. Annual rate and predictors of conversion to dementia in subjects presenting mild cognitive impairment criteria defined according to a population-based study. Dement Geriatr Cogn Disord. 2004;18(1):87-93. doi: 10.1159/000077815. Epub 2004 Apr 14.

    PubMed 15087583

  • Barrios H, Narciso S, Guerreiro M, Maroco J, Logsdon R, de Mendonca A. Quality of life in patients with mild cognitive impairment. Aging Ment Health. 2013;17(3):287-92. doi: 10.1080/13607863.2012.747083. Epub 2012 Dec 7.

    PubMed 23215827

  • Bavelier D, Neville HJ. Cross-modal plasticity: where and how? Nat Rev Neurosci. 2002 Jun;3(6):443-52. doi: 10.1038/nrn848.

    PubMed 12042879

  • Burkhalter TM, Hillman CH. A narrative review of physical activity, nutrition, and obesity to cognition and scholastic performance across the human lifespan. Adv Nutr. 2011 Mar;2(2):201S-6S. doi: 10.3945/an.111.000331. Epub 2011 Mar 10.

    PubMed 22332052

  • Chieffi S, Messina G, Villano I, Messina A, Valenzano A, Moscatelli F, Salerno M, Sullo A, Avola R, Monda V, Cibelli G, Monda M. Neuroprotective Effects of Physical Activity: Evidence from Human and Animal Studies. Front Neurol. 2017 May 22;8:188. doi: 10.3389/fneur.2017.00188. eCollection 2017.

    PubMed 28588546

  • Dik M, Deeg DJ, Visser M, Jonker C. Early life physical activity and cognition at old age. J Clin Exp Neuropsychol. 2003 Aug;25(5):643-53. doi: 10.1076/jcen.25.5.643.14583.

    PubMed 12815502

  • Espino DV, Lichtenstein MJ, Palmer RF, Hazuda HP. Ethnic differences in mini-mental state examination (MMSE) scores: where you live makes a difference. J Am Geriatr Soc. 2001 May;49(5):538-48. doi: 10.1046/j.1532-5415.2001.49111.x.

    PubMed 11380745

  • Harada CN, Natelson Love MC, Triebel KL. Normal cognitive aging. Clin Geriatr Med. 2013 Nov;29(4):737-52. doi: 10.1016/j.cger.2013.07.002.

    PubMed 24094294

  • Shams A, Nobari H, Afonso J, Abbasi H, Mainer-Pardos E, Perez-Gomez J, Bayati M, Bahrami A, Carneiro L. Effect of Aerobic-Based Exercise on Psychological Well-Being and Quality of Life Among Older People: A Middle East Study. Front Public Health. 2021 Dec 6;9:764044. doi: 10.3389/fpubh.2021.764044. eCollection 2021.

    PubMed 34938705

  • Xue J, Li J, Liang J, Chen S. The Prevalence of Mild Cognitive Impairment in China: A Systematic Review. Aging Dis. 2018 Aug 1;9(4):706-715. doi: 10.14336/AD.2017.0928. eCollection 2018 Aug.

    PubMed 30090658

Questions about this trial

What is this clinical trial studying?

A study testing Overground Walking in people with Cognitive Impairment and Aging, run by Universitas Padjadjaran at 1 site in Indonesia.

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 6 inclusion and 7 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 7 Nov 2023. 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 Indonesia. 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?

BDNF (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06029920, which also lists 10 linked publications.

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 7 Nov 2023.

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