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Clinical Trials/NCT05862935
NCT05862935
Completed
Not Applicable

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

European University Miguel de Cervantes1 site in 1 country26 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
European University Miguel de Cervantes
Enrollment
26
Locations
1
Primary Endpoint
Short Physical Performance Battery
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
February 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
European University Miguel de Cervantes
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Short Physical Performance Battery

Time Frame: 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 Outcomes

  • 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 Sites (1)

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