NCT05862935

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

May 3, 2023

Last Update Submit

January 10, 2024

Conditions

Alzheimer Disease

Keywords

DementiaPhysical exerciseLocomotion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Handgrip strength

    0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining

  • Body mass index

    0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining

  • 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)

Study Arms (2)

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

EXPERIMENTAL

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)

Other: Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2Other: Supervised Physical Activity: Phase 1

Control

NO INTERVENTION

These patients only receive the usual treatment for their pathology.

Interventions

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

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.

Also known as: AMRAP intervention
Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)
Supervised Physical Activity: Phase 1OTHER

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.

Also known as: Basic strength intervention
Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Surgery in the last 3 months
  • Exhibit clear signs of disorientation
  • Clinically confirmed signs of aggressiveness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea Miguel de Cervantes

Valladolid, 47012, Spain

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The persons analyzing the data collected (investigators, statician) will not know to which group each person belongs.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 17, 2023

Study Start

June 1, 2022

Primary Completion

January 15, 2023

Study Completion

February 1, 2023

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)