NCT06029920

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 1, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

September 1, 2023

Last Update Submit

November 5, 2023

Conditions

Keywords

ExerciseRehabilitation

Outcome Measures

Primary Outcomes (5)

  • BDNF

    Brain-derived neurotrophic factor level

    8 weeks

  • IL6

    Interleukin-6 level

    8 weeks

  • hsCRP

    hs-CRP level

    8 weeks

  • MoCAINA

    MONTREAL COGNITIVE ASSESSMENT INDONESIA

    8 weeks

  • ADQOL

    Alzheimer disease Quality of Life

    8 weeks

Study Arms (1)

Subjects

EXPERIMENTAL
Other: Overground Walking

Interventions

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.

Subjects

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing Home

Bandung, West Java, Indonesia

Location

Related Publications (10)

  • 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.

    PMID: 15087583BACKGROUND
  • 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.

    PMID: 23215827BACKGROUND
  • Bavelier D, Neville HJ. Cross-modal plasticity: where and how? Nat Rev Neurosci. 2002 Jun;3(6):443-52. doi: 10.1038/nrn848.

    PMID: 12042879BACKGROUND
  • 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.

    PMID: 22332052BACKGROUND
  • 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.

    PMID: 28588546BACKGROUND
  • 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.

    PMID: 12815502BACKGROUND
  • 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.

    PMID: 11380745BACKGROUND
  • 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.

    PMID: 24094294BACKGROUND
  • 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.

    PMID: 34938705BACKGROUND
  • 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.

    PMID: 30090658BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 8, 2023

Study Start

September 5, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations