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

Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06029920
• Other study ID #: IKFR.2023.08.01
• Status: Completed
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Other:
• Overground Walking
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.

Locations

Country	Name	City	State
Indonesia	Nursing Home	Bandung	Jawa Barat

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

References & 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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDNF	Brain-derived neurotrophic factor level	8 weeks
Primary	IL6	Interleukin-6 level	8 weeks
Primary	hsCRP	hs-CRP level	8 weeks
Primary	MoCAINA	MONTREAL COGNITIVE ASSESSMENT INDONESIA	8 weeks
Primary	ADQOL	Alzheimer disease Quality of Life	8 weeks