search
Back to results

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

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2
Supervised Physical Activity: Phase 1
Sponsored by
European University Miguel de Cervantes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Dementia, Physical exercise, Locomotion

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Europea Miguel de Cervantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)

Control

Arm Description

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)

These patients only receive the usual treatment for their pathology.

Outcomes

Primary Outcome Measures

Short Physical Performance Battery
Changes in the SPPB Score (Short Physical Performance Battery; Range between 0 "worst performance" and 12 "best performance")

Secondary Outcome Measures

Handgrip strength
Changes in the hang-up strength in the dominant side
Body mass index
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.
This variable evaluates the applicability of this tipe of training in patients with Alzheimer disease

Full Information

First Posted
May 3, 2023
Last Updated
May 18, 2023
Sponsor
European University Miguel de Cervantes
Collaborators
Asociación de Familiares de Alzheimer de Valladolid
search

1. Study Identification

Unique Protocol Identification Number
NCT05862935
Brief Title
Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease
Official Title
Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European University Miguel de Cervantes
Collaborators
Asociación de Familiares de Alzheimer de Valladolid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Is a basic strength training enough to improve physical function in AD patients? Is an exercise intervention able to delayed the progression of the disease? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Dementia, Physical exercise, Locomotion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The persons analyzing the data collected (investigators, statician) will not know to which group each person belongs.
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
No Intervention
Arm Description
These patients only receive the usual treatment for their pathology.
Intervention Type
Other
Intervention Name(s)
Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2
Other Intervention Name(s)
AMRAP intervention
Intervention Description
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
Intervention Name(s)
Supervised Physical Activity: Phase 1
Other Intervention Name(s)
Basic strength intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
Changes in the SPPB Score (Short Physical Performance Battery; Range between 0 "worst performance" and 12 "best performance")
Time Frame
0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Changes in the hang-up strength in the dominant side
Time Frame
0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Title
Body mass index
Description
Changes in the body mass index
Time Frame
0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Title
Practicability of AMRAP (As Many Repetitions As Possible) training; it will be analysed by calculating both intra- and inter-subject coefficient variation.
Description
This variable evaluates the applicability of this tipe of training in patients with Alzheimer disease
Time Frame
Every session (during 13 sessions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Universidad Europea Miguel de Cervantes
City
Valladolid
ZIP/Postal Code
47012
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs