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Completed

NCT Number: NCT05862935

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.

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Key information

Conditions

Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea Miguel de Cervantes

Valladolid, 47012, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2

Other

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

Supervised Physical Activity: Phase 1

Other

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

Primary outcomes

  1. 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")

Secondary outcomes

  1. 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

  2. Body mass index

    Time frame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining

    Changes in the body mass index

  3. 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

Sponsors and collaborators

Lead sponsor

European University Miguel de Cervantes

Other

Collaborators

  • Asociación de Familiares de Alzheimer de Valladolid

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2023
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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