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

Study Overview
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Brief Summary
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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: Is a basic strength training enough to improve physical function in AD patients? Is an exercise intervention able to delayed the progression of the disease? 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.

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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2
* Other: Supervised Physical Activity: Phase 1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)<br>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 (AMRAP -As Many Repetitions As Possible): Phase 2<br>* 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.<br>* Other names: AMRAP intervention;Other: Supervised Physical Activity: Phase 1<br>* 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.<br>* Other names: Basic strength intervention;|
| No Intervention: Control<br>These patients only receive the usual treatment for their pathology. | |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Physical exercise, Locomotion