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Completed

NCT Number: NCT06029920

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

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nursing Home

Bandung, West Java, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Overground Walking

Other

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.

Primary outcomes

  1. BDNF

    Time frame: 8 weeks

    Brain-derived neurotrophic factor level

  2. IL6

    Time frame: 8 weeks

    Interleukin-6 level

  3. hsCRP

    Time frame: 8 weeks

    hs-CRP level

  4. MoCAINA

    Time frame: 8 weeks

    MONTREAL COGNITIVE ASSESSMENT INDONESIA

  5. ADQOL

    Time frame: 8 weeks

    Alzheimer disease Quality of Life

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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