Clinical trial NCT03167840: Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment
Official title: Falls Prevention Through Physical And Cognitive Training (Falls PACT) in Older Adults With Mild Cognitive Impairment: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: falls prevention, older adults, mild cognitive impairment
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: University of Santo Tomas
First posted: 2017-05-30
Enrollment: 95
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomised controlled trial aims to determine the effectiveness of combined physical and cognitive training in preventing falls and decreasing risks of falls among community-dwelling older persons with mild cognitive impairment (MCI).

Detailed description: This is a single-blind, multicentre, randomised controlled trial. Community-dwelling older adults with MCI aged 60 or above will be recruited. They will be randomly allocated into four groups: Physical Training alone (PT), Cognitive Training alone (CT), combined Physical And Cognitive Training (PACT) and wait-list group (WG). Assessors blinded to participant allocation will conduct pre-test, posttest, and 6-month follow-up assessments.

Eligibility criteria: Inclusion Criteria:

* 60 years or above
* community-dwelling in Manila, Philippines
* diagnosed with MCI

Exclusion Criteria:

* diagnosis of dementia or Alzheimer's disease
* history of major medical conditions such as cerebrovascular disease, cardiopulmonary condition, serious musculoskeletal disease, cancer, major psychiatric condition
* have severe visual and/or hearing impairment
* taking medications such sedatives, antidepressants, diuretics, anti-epilepsy.

Primary outcomes:
measure: Falls Rate
timeFrame: 9 months
Secondary outcomes:
measure: Change in Physiologic Profile Assessment (PPA) score
timeFrame: Baseline, 3 months, 9 months
measure: Change in Falls Risks for Older People in the Community (FROP-Com) Screen score
timeFrame: Baseline, 3 months, 9 months
measure: Change in Global Cognitive Function
timeFrame: Baseline, 3 months, 9 months
measure: Change in Memory Function
timeFrame: Baseline, 3 months, 9 months
measure: Change in Executive Function
timeFrame: Baseline, 3 months, 9 months
measure: Change in Balance
timeFrame: Baseline, 3 months, 9 months
measure: Change in Gait Speed
timeFrame: Baseline, 3 months, 9 months
measure: Change in Muscle Strength
timeFrame: Baseline, 3 months, 9 months
Other outcomes:
measure: Change in Fear of Falling
timeFrame: Baseline, 3 months, 9 months
measure: Change in Quality of Life
timeFrame: Baseline, 3 months, 9 months
Locations:
city: Manila
country: Philippines
facility: University of Santo Tomas
state: Metro Manila
Study officials:
affiliation: The Hong Kong Polytechnic University - Department of Rehabilitation Sciences
name: William Tsang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lipardo DS, Tsang WWN. Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol. BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.