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Clinical Trials/NCT05295966
NCT05295966
Completed
Not Applicable

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

Universidad Rey Juan Carlos1 site in 1 country25 target enrollmentJanuary 1, 2022
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Universidad Rey Juan Carlos
Enrollment
25
Locations
1
Primary Endpoint
Step Length during Dual task gait
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
October 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miguel Fernández del Olmo

Proffessor

Universidad Rey Juan Carlos

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Step Length during Dual task gait

Time Frame: at week 8

Variables: Step Length (m)

Cadence of Gait at preferred pace

Time Frame: at week 8

Variables: cadence (steps/min)

Speed during Dual task gait

Time Frame: at week 8

Variables: Speed (m/s)

Speed of Gait at preferred pace

Time Frame: at week 8

Variables: Speed (m/s)

Step Length of Gait at preferred pace

Time Frame: at week 8

Variables: Step Length (m)

Cadence during Dual task gait

Time Frame: at week 8

Variables: cadence (steps/min)

Time up & go test

Time Frame: at week 8

Variables: time (seconds)

Study Sites (1)

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