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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03839563
• Other study ID #: NHRI-EX108-10804PI
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Taipei Medical University
• Contact: Mau-Roung Lin, Professor
• Phone: 886-2-27361661
• Email: mrlin[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Fallers
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait characteristics	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.	12 months
Primary	Global cognition	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.	12 months
Primary	Serum levels of BDNF	Serum BDNF concentrations will be assessed.	12 months
Primary	Serum levels of IGF-1	Serum IGF-1 concentrations will be assessed.	12 months
Primary	Serum levels of VEGF	Serum VEGF concentrations will be assessed.	12 months
Secondary	Tinetti balance	The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.	12 months
Secondary	Mobility	The 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.	12 months
Secondary	Muscle strength	Grip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.	12 months
Secondary	Falls	number of falls and multiple falls	12 months
Secondary	Depressive symptoms	Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).	12 months
Secondary	Fear of falling	Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.	12 months