Multisensory Physical Exercises in People With Cognitive Impairment
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive therapy
Physiocognitive Integration
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Exercise, rehabilitation, sensory stimulation
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.
Sites / Locations
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Subjects in the intervention group will perform 20 sessions of multisensory training
Subjects in the Control Group will not perform 20 sessions of multisensory training and they will keep doing the current therapy
Outcomes
Primary Outcome Measures
Speed of Gait at preferred pace
Variables: Speed (m/s)
Speed of Gait at preferred pace
Variables: Speed (m/s)
Cadence of Gait at preferred pace
Variables: cadence (steps/min)
Cadence of Gait at preferred pace
Variables: cadence (steps/min)
Step Length of Gait at preferred pace
Variables: Step Length (m)
Step Length of Gait at preferred pace
Variables: Step Length (m)
Speed during Dual task gait
Variables: Speed (m/s)
Speed during Dual task gait
Variables: Speed (m/s)
Cadence during Dual task gait
Variables: cadence (steps/min)
Cadence during Dual task gait
Variables: cadence (steps/min)
Step Length during Dual task gait
Variables: Step Length (m)
Step Length during Dual task gait
Variables: Step Length (m)
Time up & go test
Variables: time (seconds)
Time up & go test
Variables: time (seconds)
Secondary Outcome Measures
Full Information
NCT ID
NCT05295966
First Posted
February 21, 2022
Last Updated
May 8, 2023
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT05295966
Brief Title
Multisensory Physical Exercises in People With Cognitive Impairment
Official Title
Effects of Multisensory Physical Exercises in People With Moderate Cognitive Impairment or Mild Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Exercise, rehabilitation, sensory stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Subjects in the intervention group will perform 20 sessions of multisensory training
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Subjects in the Control Group will not perform 20 sessions of multisensory training and they will keep doing the current therapy
Intervention Type
Other
Intervention Name(s)
Cognitive therapy
Intervention Description
Cognitive therapy
Intervention Type
Behavioral
Intervention Name(s)
Physiocognitive Integration
Intervention Description
Physiocognitive Integration
Primary Outcome Measure Information:
Title
Speed of Gait at preferred pace
Description
Variables: Speed (m/s)
Time Frame
baseline
Title
Speed of Gait at preferred pace
Description
Variables: Speed (m/s)
Time Frame
at week 8
Title
Cadence of Gait at preferred pace
Description
Variables: cadence (steps/min)
Time Frame
baseline
Title
Cadence of Gait at preferred pace
Description
Variables: cadence (steps/min)
Time Frame
at week 8
Title
Step Length of Gait at preferred pace
Description
Variables: Step Length (m)
Time Frame
baseline
Title
Step Length of Gait at preferred pace
Description
Variables: Step Length (m)
Time Frame
at week 8
Title
Speed during Dual task gait
Description
Variables: Speed (m/s)
Time Frame
baseline
Title
Speed during Dual task gait
Description
Variables: Speed (m/s)
Time Frame
at week 8
Title
Cadence during Dual task gait
Description
Variables: cadence (steps/min)
Time Frame
Baseline
Title
Cadence during Dual task gait
Description
Variables: cadence (steps/min)
Time Frame
at week 8
Title
Step Length during Dual task gait
Description
Variables: Step Length (m)
Time Frame
Baseline
Title
Step Length during Dual task gait
Description
Variables: Step Length (m)
Time Frame
at week 8
Title
Time up & go test
Description
Variables: time (seconds)
Time Frame
baseline
Title
Time up & go test
Description
Variables: time (seconds)
Time Frame
at week 8
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Multisensory Physical Exercises in People With Cognitive Impairment
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