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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862935
• Other study ID #: PI-DOC002-ALP
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2024
• Source: European University Miguel de Cervantes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 1, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Universidad Europea Miguel de Cervantes	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
European University Miguel de Cervantes	Asociación de Familiares de Alzheimer de Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Handgrip strength	Changes in the hang-up strength in the dominant side	0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Secondary	Body mass index	Changes in the body mass index	0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Secondary	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)