Skip to content

Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults

Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03839563
Enrollment
189
Registered
2019-02-15
Start date
2019-02-15
Completion date
2023-12-31
Last updated
2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallers, Mild Cognitive Impairment

Keywords

Biomarker, Cognitive impairment, Gait abnormality, Older Adults, Exercise

Brief summary

The effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Third, whether changes in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.

Interventions

BEHAVIORALExercise

Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.

Sponsors

National Health Research Institutes, Taiwan
CollaboratorOTHER
Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

A pragmatic, single-blinded, randomized controlled trial with three arms will be conducted to investigate the effectiveness of conventional exercise and tai chi chuan, compared to health education/usual physical activity.

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* At least 65 years old * Had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months) * Can ambulate independently * Has mild cognitive impairment

Exclusion criteria

* Do not live in a community setting * Cannot ambulate independently and communicate with researchers * Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia) * Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

Design outcomes

Primary

MeasureTime frameDescription
Gait characteristics12 monthsPerformance on six gait characteristics (velocity, cadence, stride length, swing time, stride length variability, and swing time variability) will be measured with a 6-m electronic walkway of GAITRite.
Global cognition12 monthsGlobal cognition will be assessed using the Mini-Mental State Examination (MMSE). The MMSE comprises 11 questions, and the score ranges 0\ 30, with lower scores indicating poorer global cognition.
Serum levels of BDNF12 monthsSerum BDNF concentrations will be assessed.
Serum levels of IGF-112 monthsSerum IGF-1 concentrations will be assessed.
Serum levels of VEGF12 monthsSerum VEGF concentrations will be assessed.

Secondary

MeasureTime frameDescription
Tinetti balance12 monthsThe Tinetti balance score ranges 0\ 26, with a higher score indicating a better balance ability.
Fear of falling12 monthsFear of falling will be assessed using the Falls Efficacy Scale (FES) test.
Mobility12 monthsThe timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.
Muscle strength12 monthsGrip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.
Falls12 monthsnumber of falls and multiple falls
Depressive symptoms12 monthsDepressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).

Countries

Taiwan

Contacts

Primary ContactMau-Roung Lin, Professor
mrlin@tmu.edu.tw886-2-27361661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026