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

NCT ID: NCT04439097

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-07-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

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.

Group Type: EXPERIMENTAL

Multicomponent physical exercise program associated with a Mediterranean diet

Intervention Type: OTHER

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.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Roberto Méndez Sánchez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Méndez-Sánchez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

University of Salamanca

Salamanca, , Spain

Countries

Spain

Central Contacts

Roberto Méndez-Sánchez, PhD

Role: CONTACT

ro_mendez@usal.es

(34)923294400 ext. 3201

References

Puente-Gonzalez AS, Sanchez-Gonzalez F, Hernandez-Xumet JE, Sanchez-Sanchez MC, Barbero-Iglesias FJ, Mendez-Sanchez R. 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 disease: Randomized controlled clinical trial study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22385. doi: 10.1097/MD.0000000000022385.

Reference Type: DERIVED

PMID: 32957420 (View on PubMed)

Other Identifiers

02102009-USalamanca

Identifier Type: -

Identifier Source: org_study_id