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Clinical Trials/NCT03839563
NCT03839563RecruitingNot Applicable

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

Taipei Medical University2 sites in 1 country189 target enrollmentStarted: February 15, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
189
Locations
2
Primary Endpoint
Serum levels of IGF-1

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
65 Years to 100 Years (Older Adult)
Sex
All
Accepts 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)

Outcomes

Primary Outcomes

Serum levels of IGF-1

Time Frame: 12 months

Serum IGF-1 concentrations will be assessed.

Serum levels of BDNF

Time Frame: 12 months

Serum BDNF concentrations will be assessed.

Serum levels of VEGF

Time Frame: 12 months

Serum VEGF concentrations will be assessed.

Gait characteristics

Time Frame: 12 months

Performance 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 cognition

Time Frame: 12 months

Global 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.

Secondary Outcomes

  • Falls(12 months)
  • Mobility(12 months)
  • Fear of falling(12 months)
  • Muscle strength(12 months)
  • Tinetti balance(12 months)
  • Depressive symptoms(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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