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

Primary Purpose

Cognitive Impairment, Aging

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Overground Walking
Sponsored by
Universitas Padjadjaran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring Exercise, Rehabilitation

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nursing HomeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects

Arm Description

Outcomes

Primary Outcome Measures

BDNF
Brain-derived neurotrophic factor level
IL6
Interleukin-6 level
hsCRP
hs-CRP level
MoCAINA
MONTREAL COGNITIVE ASSESSMENT INDONESIA
ADQOL
Alzheimer disease Quality of Life

Secondary Outcome Measures

Full Information

First Posted
September 1, 2023
Last Updated
October 2, 2023
Sponsor
Universitas Padjadjaran
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1. Study Identification

Unique Protocol Identification Number
NCT06029920
Brief Title
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Padjadjaran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Aging
Keywords
Exercise, Rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Overground Walking
Intervention Description
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 Outcome Measure Information:
Title
BDNF
Description
Brain-derived neurotrophic factor level
Time Frame
8 weeks
Title
IL6
Description
Interleukin-6 level
Time Frame
8 weeks
Title
hsCRP
Description
hs-CRP level
Time Frame
8 weeks
Title
MoCAINA
Description
MONTREAL COGNITIVE ASSESSMENT INDONESIA
Time Frame
8 weeks
Title
ADQOL
Description
Alzheimer disease Quality of Life
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irma Ruslina Defi
Phone
081316908139
Email
Irma.ruslina@unpad.ac.id
Facility Information:
Facility Name
Nursing Home
City
Bandung
State/Province
Jawa Barat
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunarti

12. IPD Sharing Statement

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

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