Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment

NCT ID: NCT03167840

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physical training alone (PT)

Physical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity.

Group Type EXPERIMENTAL

Physical Training

Intervention Type BEHAVIORAL

Physical training alone

Cognitive training alone (CT)

Cognitive training with a focus on orientation, memory, attention and executive functioning for 60-90 minutes per session, once per week for 12 weeks.

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

Cognitive training alone

Physical and cognitive training (PACT)

Integrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks.

Group Type EXPERIMENTAL

Physical and Cognitive Training

Intervention Type BEHAVIORAL

Physical Exercise and Cognitive Training

Wait-list group (WG)

The control group on wait-list. They will be instructed to go on with their usual activities and will receive the intervention, combined physical and cognitive training, at a later date.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical and Cognitive Training

Physical Exercise and Cognitive Training

Intervention Type BEHAVIORAL

Physical Training

Physical training alone

Intervention Type BEHAVIORAL

Cognitive training

Cognitive training alone

Intervention Type BEHAVIORAL

Other Intervention Names

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Integrated cognitive training in physical exercise Physical exercise Mental exercise

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Santo Tomas

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Tsang, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University - Department of Rehabilitation Sciences

Locations

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University of Santo Tomas

Manila, National Capital Region, Philippines

Site Status

Countries

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Philippines

References

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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.

Reference Type DERIVED
PMID: 30143002 (View on PubMed)

Other Identifiers

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HSEARS20170402001

Identifier Type: -

Identifier Source: org_study_id

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