Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease

January 10, 2024 updated by: European University Miguel de Cervantes

The goal of this non-randomized clinical trial is to assess the effects of strength training in the physical function of Alzheimer's disease (AD) patients. The main question it aims to answer are:

  1. Is a basic strength training enough to improve physical function in AD patients?
  2. Is an exercise intervention able to delayed the progression of the disease?
  3. Is an AMRAP intervention feasible in AD patients?

Participants in the exercise group will perform a 16-weeks program divided in two phases (phase 1: basic strength training; phase 2: AMRAP training). Participants in both (exercise and control) groups will receive their usual care treatments which include occupational therapy, musicotherapy, cognitive stimulation and sensory stimulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 (Actual)

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.
26

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 Locations

  • Spain
      • Valladolid, Spain, 47012
        • Universidad Europea Miguel de Cervantes

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • MMSE (Mini-Metal State Examination) score of ≥15 out of 35 (at screening less than 2 months prior to baseline visit)
  • Age ≥60 years old
  • Be able to walk with or without aids
  • Be able to follow verbal instructions

Exclusion Criteria:

  • Surgery in the last 3 months
  • Exhibit clear signs of disorientation
  • Clinically confirmed signs of aggressiveness

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
No Intervention: Control
These patients only receive the usual treatment for their pathology.
Experimental: Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)

These patients, in addition to receiving the usual treatment for their pathology, carry out supervised activity consisting of:

  • Warm-up
  • Strength circuit; At phase I it will be a standard strength training, while at Phase 2 it will be an AMRAP training)
Other: Supervised Physical Activity: Phase 1
40-60 min/session, 3 times/week for 12 weeks. After a 5-min warm-up, participants performed 6 global functional exercises: i) sit-to-stand; ii) chest press, iii) forward lunges; iv) unilateral shoulder raises; v) unilateral row; and vi) heel raises. The initial volume is 2 sets and 8 repetitions and it will progressively increase until 3 sets and 12 repetitions.
Other Names:
  • Basic strength intervention
Other: Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2
20-30 min/session, 3 times/week for 4 weeks. After a 5-min warm-up, participants perform a moderate-intensity functional training program. This program is designed in circuit mode consisting of 6 global functional exercises: i) sit and stand, ii) forward lunges, iii) chest press, iv) high row, v) lateral shoulder raises and vi) heel raises. Participants must complete the highest number of repetitions and/or rounds as possible (AMRAP) in 15-min without a designated rest.
Other Names:
  • AMRAP intervention

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
Short Physical Performance Battery
Time Frame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Changes in the SPPB Score (Short Physical Performance Battery; Range between 0 "worst performance" and 12 "best performance")
0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining

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
Handgrip strength
Time Frame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Changes in the hang-up strength in the dominant side
0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Body mass index
Time Frame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Changes in the body mass index
0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Practicability of AMRAP (As Many Repetitions As Possible) training; it will be analysed by calculating both intra- and inter-subject coefficient variation.
Time Frame: Every session (during 13 sessions)
This variable evaluates the applicability of this tipe of training in patients with Alzheimer disease
Every session (during 13 sessions)

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.
European University Miguel de Cervantes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Asociación de Familiares de Alzheimer de Valladolid

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 (Actual)

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.
June 1, 2022

Primary Completion (Actual)

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.
January 15, 2023

Study Completion (Actual)

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.
February 1, 2023

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).
May 3, 2023

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.
May 15, 2023

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.
May 17, 2023

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.
January 11, 2024

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.
January 10, 2024

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.
January 1, 2024

More Information

Terms related to this study

Keywords

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.
  • PI-DOC002-ALP

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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