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Completed

NCT Number: NCT05295966

Multisensory Physical Exercises in People With Cognitive Impairment

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.

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Key information

Conditions

Dementia Behavior Brain Diseases Central Nervous System Diseases Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Rey Juan Carlos

Fuenlabrada, Madrid, 28942, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive therapy

Other

Cognitive therapy

Physiocognitive Integration

Behavioral

Physiocognitive Integration

Primary outcomes

  1. Speed of Gait at preferred pace

    Time frame: baseline

    Variables: Speed (m/s)

  2. Speed of Gait at preferred pace

    Time frame: at week 8

    Variables: Speed (m/s)

  3. Cadence of Gait at preferred pace

    Time frame: baseline

    Variables: cadence (steps/min)

  4. Cadence of Gait at preferred pace

    Time frame: at week 8

    Variables: cadence (steps/min)

  5. Step Length of Gait at preferred pace

    Time frame: baseline

    Variables: Step Length (m)

  6. Step Length of Gait at preferred pace

    Time frame: at week 8

    Variables: Step Length (m)

  7. Speed during Dual task gait

    Time frame: baseline

    Variables: Speed (m/s)

  8. Speed during Dual task gait

    Time frame: at week 8

    Variables: Speed (m/s)

  9. Cadence during Dual task gait

    Time frame: Baseline

    Variables: cadence (steps/min)

  10. Cadence during Dual task gait

    Time frame: at week 8

    Variables: cadence (steps/min)

  11. Step Length during Dual task gait

    Time frame: Baseline

    Variables: Step Length (m)

  12. Step Length during Dual task gait

    Time frame: at week 8

    Variables: Step Length (m)

  13. Time up & go test

    Time frame: baseline

    Variables: time (seconds)

  14. Time up & go test

    Time frame: at week 8

    Variables: time (seconds)

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2022
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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