NCT03167840

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

April 27, 2018

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

May 22, 2017

Last Update Submit

April 26, 2018

Conditions

Mild Cognitive Impairment

Keywords

falls prevention, older adults, mild cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Falls Rate

    Number of Falls over a period of time

    9 months

Secondary Outcomes (8)

  • Change in Physiologic Profile Assessment (PPA) score

    Baseline, 3 months, 9 months

  • Change in Falls Risks for Older People in the Community (FROP-Com) Screen score

    Baseline, 3 months, 9 months

  • Change in Global Cognitive Function

    Baseline, 3 months, 9 months

  • Change in Memory Function

    Baseline, 3 months, 9 months

  • Change in Executive Function

    Baseline, 3 months, 9 months

  • +3 more secondary outcomes

Other Outcomes (2)

  • Change in Fear of Falling

    Baseline, 3 months, 9 months

  • Change in Quality of Life

    Baseline, 3 months, 9 months

Study Arms (4)

Physical training alone (PT)

EXPERIMENTAL

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

Behavioral: Physical Training

Cognitive training alone (CT)

EXPERIMENTAL

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

Behavioral: Cognitive training

Physical and cognitive training (PACT)

EXPERIMENTAL

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

Behavioral: Physical and Cognitive Training

Wait-list group (WG)

NO INTERVENTION

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.

Interventions

Physical and Cognitive TrainingBEHAVIORAL

Physical Exercise and Cognitive Training

Also known as: Integrated cognitive training in physical exercise
Physical and cognitive training (PACT)
Physical TrainingBEHAVIORAL

Physical training alone

Also known as: Physical exercise
Physical training alone (PT)
Cognitive trainingBEHAVIORAL

Cognitive training alone

Also known as: Mental exercise
Cognitive training alone (CT)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Santo Tomas

Manila, National Capital Region, 1015, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 30143002DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Restraint, PhysicalCognitive TrainingExercisePhysical Conditioning, Human

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative TechniquesNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • William Tsang, PhD

    The Hong Kong Polytechnic University - Department of Rehabilitation Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 30, 2017

Study Start

September 6, 2017

Primary Completion

January 31, 2018

Study Completion

August 31, 2018

Last Updated

April 27, 2018

Record last verified: 2017-05

Locations

PH(1)