Clinical trial NCT04439097: Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Physical Exercise
Bone Density
Fall
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized parallel-group, single blinded controlled clinical trial
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: Change in gait and balance 1
timeFrame: 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)]
measure: Change in gait and balance 2
timeFrame: 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)]
measure: Change in Bone Mineral Density (BMD)
timeFrame: 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)]
measure: Change in T-Score as primary parameter of bone health
timeFrame: 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:
measure: Change in static balance
timeFrame: 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)]
measure: Change in proactive balance
timeFrame: 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)]
measure: Falls during the study
timeFrame: 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)]
measure: Change in the Broadband ultrasound attenuation (BUA) as secondary parameter of bone health
timeFrame: 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)]
measure: Change in the Speed of sound (SOS) as secondary parameter of bone health
timeFrame: 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)]
measure: Change in the Quantitative ultrasound index (QUI) as secondary parameter of bone health
timeFrame: 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)]
measure: Change in the nutritional status
timeFrame: 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)]
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
affiliation: University of Salamanca
name: Roberto Méndez-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.