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

NCT04439097 | Unknown

• 1 other identifier: 02102009-USalamanca
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in gait and balance 1

  Tinetti's Performance Oriented Mobility Assessment (POMA-T) will be used (points). the original POMA-T 28-point version. It consists of a balance scale (Balance performance oriented mobility assessment (POMA-B) can score 16 points) and a gait scale (Gait performance oriented mobility assessment (POMA-G) can score 12 points )

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

• Change in gait and balance 2

  Timed up and go test (TUG) will be used (s). IT measures the time in seconds for the subjects to get up from a standard armchair, walk 3 metres, turn, walk back to the chair and sit down. The cut-off point for normal mobility is 12 seconds and values \> 30 s indicate a high level of dependence. (a time \<10s it is considered normal; \<20s mobility difficulties and low or moderate risk of falls; \> 20 mobility problems with need of help and high risk of falls)

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

• Change in Bone Mineral Density (BMD)

  Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the estimated BMD (g/cm2).

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

• Change in T-Score as primary parameter of bone health

  Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the T-Score. A T-score shows how much the BMD is higher or lower than the BMD of a healthy 30-year old adult. (-1.0 or above normal BMD; From -1.0 to -2.5 low BMD or osteopenia; -2.5 or below very low BMD and diagnosis of osteoporosis.

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

Secondary Outcomes (7)

• Change in static balance

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

• Change in proactive balance

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

• Falls during the study

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

• Change in the Broadband ultrasound attenuation (BUA) as secondary parameter of bone health

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

• Change in the Speed of sound (SOS) as secondary parameter of bone health

  6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Multicomponent physical exercise program associated with a Mediterranean diet

Control Group

ACTIVE COMPARATOR

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.

Other: Usual care

Interventions

Multicomponent physical exercise program associated with a Mediterranean diet 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.

Experimental Group

Usual care 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.

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, 37007, Spain

Location

Related Publications (1)

• 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.

  PMID: 32957420 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Roberto Méndez-Sánchez, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Méndez-Sánchez, PhD

CONTACT

(34)923294400; ro_mendez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: will perform all evaluations without knowing the group to which the patients have been assigned, and they will not have a relationship with the physiotherapist who applies the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a randomized parallel-group, single blinded controlled clinical trial

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: September 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)