DementiaNCT05295966
Multisensory Physical Exercises in People With Cognitive Impairment
A study testing Cognitive therapy and Physiocognitive Integration in people with Dementia, run by Universidad Rey Juan Carlos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Cognitive therapy and Physiocognitive Integration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Multisensory Physical Exercises in People With Moderate Cognitive Impairment or Mild Dementia
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.
Read the 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
- Being tested
- Cognitive therapy, Physiocognitive Integration
- Keywords
- Exercise, rehabilitation, sensory stimulation
- Medical subject headings
- Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive therapyOther
Cognitive therapy
Physiocognitive IntegrationBehavioural
Physiocognitive Integration
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Subjects in the intervention group will perform 20 sessions of multisensory training Receives: Other: Cognitive therapy; Behavioral: Physiocognitive Integration |
| Control Group | Active comparator | Subjects in the Control Group will not perform 20 sessions of multisensory training and they will keep doing the current therapy Receives: Other: Cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of Gait at preferred pace
Variables: Speed (m/s)
Measured: baseline
Speed of Gait at preferred pace
Variables: Speed (m/s)
Measured: at week 8
Cadence of Gait at preferred pace
Variables: cadence (steps/min)
Measured: baseline
Cadence of Gait at preferred pace
Variables: cadence (steps/min)
Measured: at week 8
Step Length of Gait at preferred pace
Variables: Step Length (m)
Measured: baseline
Step Length of Gait at preferred pace
Variables: Step Length (m)
Measured: at week 8
Speed during Dual task gait
Variables: Speed (m/s)
Measured: baseline
Speed during Dual task gait
Variables: Speed (m/s)
Measured: at week 8
Cadence during Dual task gait
Variables: cadence (steps/min)
Measured: Baseline
Cadence during Dual task gait
Variables: cadence (steps/min)
Measured: at week 8
Step Length during Dual task gait
Variables: Step Length (m)
Measured: Baseline
Step Length during Dual task gait
Variables: Step Length (m)
Measured: at week 8
Time up & go test
Variables: time (seconds)
Measured: baseline
Time up & go test
Variables: time (seconds)
Measured: at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Jan 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Fernández del Olmo, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295966
- Sponsor's protocol ID
- V1058
- Status last verified
- Mar 2022
- First submitted
- 21 Feb 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multisensory Physical Exercises in People With Moderate Cognitive Impairment or Mild Dementia
- ClinicalTrials.gov ID
- NCT05295966
- Acronym / sponsor ID
- V1058
- Conditions
- Dementia
- Keywords
- Exercise, rehabilitation, sensory stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Cognitive therapy, Behavioral: Physiocognitive IntegrationSubjects in the intervention group will perform 20 sessions of multisensory training |
| Control Group | Active comparator | Other: Cognitive therapySubjects in the Control Group will not perform 20 sessions of multisensory training and they will keep doing the current therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive therapyCognitive therapy | Other | Control Group, Intervention Group |
| Physiocognitive IntegrationPhysiocognitive Integration | Behavioural | Intervention Group |
Primary outcome
Speed of Gait at preferred pace
Time frame: baseline
Variables: Speed (m/s)
Speed of Gait at preferred pace
Time frame: at week 8
Variables: Speed (m/s)
Cadence of Gait at preferred pace
Time frame: baseline
Variables: cadence (steps/min)
Cadence of Gait at preferred pace
Time frame: at week 8
Variables: cadence (steps/min)
Step Length of Gait at preferred pace
Time frame: baseline
Variables: Step Length (m)
Step Length of Gait at preferred pace
Time frame: at week 8
Variables: Step Length (m)
Speed during Dual task gait
Time frame: baseline
Variables: Speed (m/s)
Speed during Dual task gait
Time frame: at week 8
Variables: Speed (m/s)
Cadence during Dual task gait
Time frame: Baseline
Variables: cadence (steps/min)
Cadence during Dual task gait
Time frame: at week 8
Variables: cadence (steps/min)
Step Length during Dual task gait
Time frame: Baseline
Variables: Step Length (m)
Step Length during Dual task gait
Time frame: at week 8
Variables: Step Length (m)
Time up & go test
Time frame: baseline
Variables: time (seconds)
Time up & go test
Time frame: at week 8
Variables: time (seconds)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive therapy and Physiocognitive Integration in people with Dementia, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of Gait at preferred pace (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 26 Oct 2026.