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

Not Applicable

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT05862935
• Lead Sponsor: European University Miguel de Cervantes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-01-15
• Study Completion: 2023-02-01
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery	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 Outcome Measures

Name	Time	Method
Handgrip strength	0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining	Changes in the hang-up strength in the dominant side
Body mass index	0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining	Changes 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

Trial Locations

Locations (1)

Universidad Europea Miguel de Cervantes; 🇪🇸 Valladolid, Spain