Multisensory Physical Exercises in People With Cognitive Impairment

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: Cognitive therapy; Behavioral: Physiocognitive Integration

• Registration Number: NCT05295966
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-02-21
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-03-25
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Cognitive therapy	Subjects in the intervention group will perform 20 sessions of multisensory training
Control Group	Cognitive therapy	Subjects in the Control Group will not perform 20 sessions of multisensory training and they will keep doing the current therapy
Intervention Group	Physiocognitive Integration	Subjects in the intervention group will perform 20 sessions of multisensory training

Primary Outcome Measures

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

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Fuenlabrada, Madrid, Spain