NCT05295966

Brief Summary

The main objective of the study is to evaluate the efficacy of a combined training program of physical exercise and multisensory stimulation (Physiocognitive Integration) in people with mild/moderate cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

May 10, 2023

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

February 21, 2022

Last Update Submit

May 8, 2023

Conditions

Dementia

Keywords

Exerciserehabilitationsensory stimulation

Outcome Measures

Primary Outcomes (14)

  • Speed of Gait at preferred pace

    Variables: Speed (m/s)

    baseline

  • Speed of Gait at preferred pace

    Variables: Speed (m/s)

    at week 8

  • Cadence of Gait at preferred pace

    Variables: cadence (steps/min)

    baseline

  • Cadence of Gait at preferred pace

    Variables: cadence (steps/min)

    at week 8

  • Step Length of Gait at preferred pace

    Variables: Step Length (m)

    baseline

  • Step Length of Gait at preferred pace

    Variables: Step Length (m)

    at week 8

  • Speed during Dual task gait

    Variables: Speed (m/s)

    baseline

  • Speed during Dual task gait

    Variables: Speed (m/s)

    at week 8

  • Cadence during Dual task gait

    Variables: cadence (steps/min)

    Baseline

  • Cadence during Dual task gait

    Variables: cadence (steps/min)

    at week 8

  • Step Length during Dual task gait

    Variables: Step Length (m)

    Baseline

  • Step Length during Dual task gait

    Variables: Step Length (m)

    at week 8

  • Time up & go test

    Variables: time (seconds)

    baseline

  • Time up & go test

    Variables: time (seconds)

    at week 8

Study Arms (2)

Intervention Group

EXPERIMENTAL

Subjects in the intervention group will perform 20 sessions of multisensory training

Other: Cognitive therapyBehavioral: Physiocognitive Integration

Control Group

ACTIVE COMPARATOR

Subjects in the Control Group will not perform 20 sessions of multisensory training and they will keep doing the current therapy

Other: Cognitive therapy

Interventions

Cognitive therapyOTHER

Cognitive therapy

Control GroupIntervention Group
Physiocognitive IntegrationBEHAVIORAL

Physiocognitive Integration

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks).
  • Caregiver or family member who presents the appropriate skills for collaboration in the implementation of the exercises and in the management of the mobile application.
  • Availability of the necessary time for the initial training in the handling of the devices, the development of the sessions and the communication with the researchers.

You may not qualify if:

  • Insufficient physical condition for participation.
  • Sensory deficits that make participation difficult.
  • Unstable clinical situation.
  • Unstable mental disorder or not adequately controlled with medication (depression, agitation, etc.).
  • Presence of associated pathology that involves treatment with drugs that alter cognitive abilities or interfere with the user's participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Fuenlabrada, Madrid, 28942, Spain

Location

MeSH Terms

Conditions

DementiaMotor Activity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 25, 2022

Study Start

January 1, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

May 10, 2023

Record last verified: 2022-03

Locations

ES(1)