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

Sponsor
Universitas Padjadjaran (Other)
Overall Status
Recruiting
CT.gov ID
NCT06029920
Collaborator
(none)
15
1
1
1.8
8.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Overground Walking
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Sep 5, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subjects

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.

Outcome Measures

Primary Outcome Measures

  1. BDNF [8 weeks]

    Brain-derived neurotrophic factor level

  2. IL6 [8 weeks]

    Interleukin-6 level

  3. hsCRP [8 weeks]

    hs-CRP level

  4. MoCAINA [8 weeks]

    MONTREAL COGNITIVE ASSESSMENT INDONESIA

  5. ADQOL [8 weeks]

    Alzheimer disease Quality of Life

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nursing Home Bandung Jawa Barat Indonesia

Sponsors and Collaborators

  • Universitas Padjadjaran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Irma Ruslina Defi, Principal Investigator, Universitas Padjadjaran
ClinicalTrials.gov Identifier:
NCT06029920
Other Study ID Numbers:
  • IKFR.2023.08.01
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Irma Ruslina Defi, Principal Investigator, Universitas Padjadjaran
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023