Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05862935
Enrollment
26
Registered
2023-05-17
Start date
2022-06-01
Completion date
2023-02-01
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Dementia, Physical exercise, Locomotion

Brief summary

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.

Interventions

OTHERSupervised 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.

OTHERSupervised 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.

Sponsors

Asociación de Familiares de Alzheimer de Valladolid
CollaboratorUNKNOWN
European University Miguel de Cervantes
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The persons analyzing the data collected (investigators, statician) will not know to which group each person belongs.

Intervention model description

Non-randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Short Physical Performance Battery0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detrainingChanges in the SPPB Score (Short Physical Performance Battery; Range between 0 worst performance and 12 best performance)

Secondary

MeasureTime frameDescription
Handgrip strength0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detrainingChanges in the hang-up strength in the dominant side
Body mass index0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detrainingChanges in the body mass index
Practicability of AMRAP (As Many Repetitions As Possible) training; it will be analysed by calculating both intra- and inter-subject coefficient variation.Every session (during 13 sessions)This variable evaluates the applicability of this tipe of training in patients with Alzheimer disease

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026