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

NCT ID: NCT05862935

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-02-01

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Supervised Physical Activity: Phase 1

Intervention Type: 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.

Control

These patients only receive the usual treatment for their pathology.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

AMRAP intervention; Basic strength intervention

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asociación de Familiares de Alzheimer de Valladolid

UNKNOWN

Sponsor Role: collaborator

European University Miguel de Cervantes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Europea Miguel de Cervantes

Valladolid, , Spain

Countries

Spain

Other Identifiers

PI-DOC002-ALP

Identifier Type: -

Identifier Source: org_study_id