NCT04439097

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

Short and Medium-term Effects of a Multicomponent Physical Exercise Program With a Mediterranean Diet on Bone Mineral Density, Gait, Balance, and Fall Risk for Patients With Alzheimer's Disease: Randomized Controlled Clinical Trial Study Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: University of Salamanca · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-09-15
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2020-06-19
• Last updated: 2021-03-09

Locations

1 site across 1 country: Spain