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

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: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: Supervised Physical Activity: Phase 1; Other: Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery	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

Outcome Measure	Measure Description	Time Frame
Handgrip strength	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	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.	This variable evaluates the applicability of this tipe of training in patients with Alzheimer disease	Every session (during 13 sessions)

Collaborators and Investigators

• Sponsor: European University Miguel de Cervantes
• Collaborators: Asociación de Familiares de Alzheimer de Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Dementia; Physical exercise; Locomotion
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID 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