Multisensory Physical Exercises in People With Cognitive Impairment

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295966
• Other study ID #: V1058
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2022
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia

Intervention

Other:
• Cognitive therapy
Cognitive therapy

Behavioral:
• Physiocognitive Integration
Physiocognitive Integration

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Fuenlabrada	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

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