Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease

NCT04439097 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-03-09

No results posted yet for this study

Summary

This study is a randomized, parallel-group, single blinded controlled clinical trial. The general objective of this multicomponent physical exercise program (MPEP) associated with a Mediterranean Diet (MeDi) is to decrease the risk of falls and fractures through the improvement of the bone health and physical functions of people with Alzheimer Disease.

Patients allocated to the intervention group will perform a MPEP with a MeDi during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session.

During the study, 4 evaluations will be carried out to assess the effects of the interventions on bone mineral density, gait, balance, and fall risk: ((1) Baseline (pre-intervention); 2) 1st post-intervention after 1 month; 3) 2nd post-intervention after 3 months; 4) Final, 3rd post-intervention after 6 months

Conditions

  • Alzheimer Disease
  • Physical Exercise
  • Bone Density
  • Fall

Interventions

OTHER

Multicomponent physical exercise program associated with a Mediterranean diet

In this basic structure of each sessions, traditional exercises of mobility, strength, balance and coordination are included with the main objective of improving functional capacities. But, besides, games and some activities are also included with the aim, not only of improving the functional capacity, but also working the cognitive functions to reinforce the global effects. The Mediterranean diet will based in these main foods: 1) vegetables; 2) fruits; 3) fish or seafood; 4) legumes; 5) nuts; 6) bread or cereals; 7) white meat; 8) eggs; and 9)olive oil.

OTHER

Usual care

Usual care and participants continue with their life normally, without participating in a standardized exercise program, and they will be instructed to maintain their current physical activity level.

Sponsors & Collaborators

  • University of Salamanca

    lead OTHER

Principal Investigators

  • Roberto Méndez-Sánchez, PhD · University of Salamanca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-07-15
Completion
2022-07-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04439097 on ClinicalTrials.gov