Multisensory Physical Exercises in People With Cognitive Impairment

NCT ID: NCT05295966

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-10-30

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Cognitive therapy

Intervention Type: OTHER

Cognitive therapy

Physiocognitive Integration

Intervention Type: BEHAVIORAL

Physiocognitive Integration

Control Group

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

Group Type: ACTIVE_COMPARATOR

Cognitive therapy

Intervention Type: OTHER

Cognitive therapy

Interventions

Cognitive therapy

Cognitive therapy

Intervention Type: OTHER

Physiocognitive Integration

Physiocognitive Integration

Intervention Type: BEHAVIORAL

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).

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Miguel Fernández del Olmo

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Rey Juan Carlos

Fuenlabrada, Madrid, Spain

Countries

Spain

Other Identifiers

V1058

Identifier Type: -

Identifier Source: org_study_id