Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease

March 7, 2021 updated by: Roberto Méndez Sánchez, University of Salamanca

Short and Medium-term Effects of a Multicomponent Physical Exercise Program With a Mediterranean Diet on Bone Mineral Density, Gait, Balance, and Fall Risk for Patients With Alzheimer's Disease: Randomized Controlled Clinical Trial Study Protocol

This study is a randomized, parallel-group, single blinded controlled clinical trial. The general objective of this multicomponent physical exercise program (MPEP) associated with a Mediterranean Diet (MeDi) is to decrease the risk of falls and fractures through the improvement of the bone health and physical functions of people with Alzheimer Disease.

Patients allocated to the intervention group will perform a MPEP with a MeDi during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session.

During the study, 4 evaluations will be carried out to assess the effects of the interventions on bone mineral density, gait, balance, and fall risk: ((1) Baseline (pre-intervention); 2) 1st post-intervention after 1 month; 3) 2nd post-intervention after 3 months; 4) Final, 3rd post-intervention after 6 months

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Roberto Méndez-Sánchez, PhD
  • Phone Number: 3201 (34)923294400
  • Email: ro_mendez@usal.es

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • University of Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes older than 50 years
  • Have a diagnosis of AD
  • Present mild or moderate cognitive impairment (Mini-mental State Examination (MMSE) score between 11 and 23 points included)
  • Acceptance to participate in the study (enrollment in the study and signing of informed consent)

Exclusion Criteria:

  • Other associated pathologies that do not allow physical exercise due to having severe functional disability or being insecure (neurological diseases, severe cardio-respiratory pathology, etc.).
  • Impossibility to carry out the evaluation tests.
  • Falls and other incidents with severe consequences that cause disability and/or that do not allow the intervention to continue.
  • Attendance at the MPEP is less than 75% in the total of the sessions between assessments. (Criterion applied to each period between assessments).
  • Not performing the MPEP sessions for 2 or more consecutive weeks.
  • Participate in another intervention program outside of this study, especially an exercise program (important intervention bias for the control group).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental Group

Patients allocated to the intervention group will perform a MPEP during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session. In addition, they will have a Mediterranean Diet.

The patients in the MPEP will be carried out in small groups of 5-8 people. Structure of sessions: 3 different parts: an initial warm-up, a main part and a final cool-down and relaxation.
Other: Multicomponent physical exercise program associated with a Mediterranean diet

In this basic structure of each sessions, traditional exercises of mobility, strength, balance and coordination are included with the main objective of improving functional capacities. But, besides, games and some activities are also included with the aim, not only of improving the functional capacity, but also working the cognitive functions to reinforce the global effects.

The Mediterranean diet will based in these main foods: 1) vegetables; 2) fruits; 3) fish or seafood; 4) legumes; 5) nuts; 6) bread or cereals; 7) white meat; 8) eggs; and 9)olive oil.
ACTIVE_COMPARATOR: Control Group
Participants allocated to the control group will receive usual care and continue with their life normally, without participating in a standardized exercise program. They will be instructed to maintain their current physical activity level.
Other: Usual care
Usual care and participants continue with their life normally, without participating in a standardized exercise program, and they will be instructed to maintain their current physical activity level.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in gait and balance 1
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Tinetti's Performance Oriented Mobility Assessment (POMA-T) will be used (points). the original POMA-T 28-point version. It consists of a balance scale (Balance performance oriented mobility assessment (POMA-B) can score 16 points) and a gait scale (Gait performance oriented mobility assessment (POMA-G) can score 12 points )
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in gait and balance 2
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Timed up and go test (TUG) will be used (s). IT measures the time in seconds for the subjects to get up from a standard armchair, walk 3 metres, turn, walk back to the chair and sit down. The cut-off point for normal mobility is 12 seconds and values > 30 s indicate a high level of dependence. (a time <10s it is considered normal; <20s mobility difficulties and low or moderate risk of falls; > 20 mobility problems with need of help and high risk of falls)
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in Bone Mineral Density (BMD)
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the estimated BMD (g/cm2).
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in T-Score as primary parameter of bone health
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the T-Score. A T-score shows how much the BMD is higher or lower than the BMD of a healthy 30-year old adult. (-1.0 or above normal BMD; From -1.0 to -2.5 low BMD or osteopenia; -2.5 or below very low BMD and diagnosis of osteoporosis.
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in static balance
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
one-leg balance test (OLB) will be used (s). This test assess the ability of the patients to remain upright on one leg without support for at least 5 seconds, and each leg was tested.
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in proactive balance
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Functional reach test (FR) will be used (cm). Is a measure of the distance in centimeters that the standing participant is able to reach forward from an initial upright posture to the maximal anterior leaning posture without moving or lifting the feet.
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Falls during the study
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
The number of falls of each subject during the study will be counted
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Broadband ultrasound attenuation (BUA) as secondary parameter of bone health
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcome we will assess the Broadband ultrasound attenuation (BUA) (dB/MHz). It is a measurement of the differential attenuation of sound waves transmitted through the calcaneus.
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Speed of sound (SOS) as secondary parameter of bone health
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcomes we will assess the SOS through the calcaneus bone (m/s). It is calculated as the ratio of the distance traveled by the impulse and the time taken by the signal to travel that distance
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the Quantitative ultrasound index (QUI) as secondary parameter of bone health
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcomes we will assess the Quantitative ultrasound index. To improve precision we will calculate de QUI, a variable derived from the mathematical combination of both SoS and BUA [0.41 × (BUA + SoS) - 571] (19), expressed as percent.
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Change in the nutritional status
Time Frame: 6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]
Nutritional status will be assessed by the Mini Nutritional Assessment (MNA) (points). Total score ranging from 0 to 30. Well nourished (MNA score >23.5), at risk of malnutrition (MNA score=17.0-23.5), or malnourished (MNA score <17).
6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02102009-USalamanca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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