Multisensory Physical Exercises in People With Cognitive Impairment

May 8, 2023 updated by: Miguel Fernández del Olmo, Universidad Rey Juan Carlos

Effects of Multisensory Physical Exercises in People With Moderate Cognitive Impairment or Mild Dementia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alzheimer's disease and other dementias are the main cause of cognitive impairment, with a prevalence of 0.4% worldwide and 1.23 in Europe. The WHO estimates that the growth of people with cognitive impairment to some degree will increase in the coming years, exceeding 75 million people in the world in 2030, and 135 million in 2050. The prevention of cognitive deterioration is mainly based on the implementation of non-pharmacological therapies. Multisensory stimulation is a non-pharmacological therapy that has benefits in patients with cognitive impairment, producing an improvement in cognitive function.

Physical exercise is associated with a lower risk of onset of cognitive impairment and less cognitive impairment as well as a slower progression in people with mild cognitive impairment and in mild-stage dementias. In addition to the cognitive sphere, the positive effect of physical exercise in preventing falls has been widely studied.

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. In order to do this, a experimental group will perform 20 sessions of multisensory training in addition to their current therapy and a second, control group, only their current therapy. Before and after the time need to complete the 20 sessions, all subjects were perform a battery of motor and cognitive tasks.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Miguel Angel Fernández del Olmo, PhD
  • Phone Number: 600077866
  • Email: mafo73@gmail.com

Study Locations

  • Spain
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Universidad Rey Juan Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks).

In the case of subjects who are part of the intervention group, the following will also be inclusion criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Subjects in the intervention group will perform 20 sessions of multisensory training
Other: Cognitive therapy
Cognitive therapy
Behavioral: Physiocognitive Integration
Physiocognitive Integration
Active Comparator: Control Group
Subjects in the Control Group will not perform 20 sessions of multisensory training and they will keep doing the current therapy
Other: Cognitive therapy
Cognitive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of Gait at preferred pace
Time Frame: baseline
Variables: Speed (m/s)
baseline
Speed of Gait at preferred pace
Time Frame: at week 8
Variables: Speed (m/s)
at week 8
Cadence of Gait at preferred pace
Time Frame: baseline
Variables: cadence (steps/min)
baseline
Cadence of Gait at preferred pace
Time Frame: at week 8
Variables: cadence (steps/min)
at week 8
Step Length of Gait at preferred pace
Time Frame: baseline
Variables: Step Length (m)
baseline
Step Length of Gait at preferred pace
Time Frame: at week 8
Variables: Step Length (m)
at week 8
Speed during Dual task gait
Time Frame: baseline
Variables: Speed (m/s)
baseline
Speed during Dual task gait
Time Frame: at week 8
Variables: Speed (m/s)
at week 8
Cadence during Dual task gait
Time Frame: Baseline
Variables: cadence (steps/min)
Baseline
Cadence during Dual task gait
Time Frame: at week 8
Variables: cadence (steps/min)
at week 8
Step Length during Dual task gait
Time Frame: Baseline
Variables: Step Length (m)
Baseline
Step Length during Dual task gait
Time Frame: at week 8
Variables: Step Length (m)
at week 8
Time up & go test
Time Frame: baseline
Variables: time (seconds)
baseline
Time up & go test
Time Frame: at week 8
Variables: time (seconds)
at week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Rey Juan Carlos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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