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

University of Salamanca

Status: Unknown

Conditions: Alzheimer Disease; Physical Exercise; Fall; Bone Density

Treatments: Other: Usual care; Other: Multicomponent physical exercise program associated with a Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04439097

02102009-USalamanca

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes older than 50 years
• Have a diagnosis of AD
• Present mild or moderate cognitive impairment (Mini-mental State Examination (MMSE) score between 11 and 23 points included)
• Acceptance to participate in the study (enrollment in the study and signing of informed consent)

Exclusion criteria

• Other associated pathologies that do not allow physical exercise due to having severe functional disability or being insecure (neurological diseases, severe cardio-respiratory pathology, etc.).
• Impossibility to carry out the evaluation tests.
• Falls and other incidents with severe consequences that cause disability and/or that do not allow the intervention to continue.
• Attendance at the MPEP is less than 75% in the total of the sessions between assessments. (Criterion applied to each period between assessments).
• Not performing the MPEP sessions for 2 or more consecutive weeks.
• Participate in another intervention program outside of this study, especially an exercise program (important intervention bias for the control group).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Patients allocated to the intervention group will perform a MPEP during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session. In addition, they will have a Mediterranean Diet. The patients in the MPEP will be carried out in small groups of 5-8 people. Structure of sessions: 3 different parts: an initial warm-up, a main part and a final cool-down and relaxation.

Treatment:

Other: Multicomponent physical exercise program associated with a Mediterranean diet

Control Group

Active Comparator group

Description:

Participants allocated to the control group will receive usual care and continue with their life normally, without participating in a standardized exercise program. They will be instructed to maintain their current physical activity level.

Treatment:

Other: Usual care