Back to resultsEffects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease
Primary Purpose
Alzheimer Disease, Physical Exercise, Bone Density
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent physical exercise program associated with a Mediterranean diet
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
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).
Sites / Locations
- University of Salamanca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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 )
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)
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).
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.
Secondary Outcome Measures
Change in static balance
one-leg balance test (OLB) will be used (s). This test assess the ability of the patients to remain upright on one leg without support for at least 5 seconds, and each leg was tested.
Change in proactive balance
Functional reach test (FR) will be used (cm). Is a measure of the distance in centimeters that the standing participant is able to reach forward from an initial upright posture to the maximal anterior leaning posture without moving or lifting the feet.
Falls during the study
The number of falls of each subject during the study will be counted
Change in the Broadband ultrasound attenuation (BUA) as secondary parameter of bone health
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcome we will assess the Broadband ultrasound attenuation (BUA) (dB/MHz). It is a measurement of the differential attenuation of sound waves transmitted through the calcaneus.
Change in the Speed of sound (SOS) as secondary parameter of bone health
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcomes we will assess the SOS through the calcaneus bone (m/s). It is calculated as the ratio of the distance traveled by the impulse and the time taken by the signal to travel that distance
Change in the Quantitative ultrasound index (QUI) as secondary parameter of bone health
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcomes we will assess the Quantitative ultrasound index. To improve precision we will calculate de QUI, a variable derived from the mathematical combination of both SoS and BUA [0.41 × (BUA + SoS) - 571] (19), expressed as percent.
Change in the nutritional status
Nutritional status will be assessed by the Mini Nutritional Assessment (MNA) (points). Total score ranging from 0 to 30. Well nourished (MNA score >23.5), at risk of malnutrition (MNA score=17.0-23.5), or malnourished (MNA score <17).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04439097
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Anticipated)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
July 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Physical Exercise, Bone Density, Fall
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized parallel-group, single blinded controlled clinical trial
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Multicomponent physical exercise program associated with a Mediterranean diet
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in gait and balance 1
Description
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 )
Time Frame
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)]
Title
Change in gait and balance 2
Description
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)
Time Frame
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)]
Title
Change in Bone Mineral Density (BMD)
Description
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the estimated BMD (g/cm2).
Time Frame
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)]
Title
Change in T-Score as primary parameter of bone health
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change in static balance
Description
one-leg balance test (OLB) will be used (s). This test assess the ability of the patients to remain upright on one leg without support for at least 5 seconds, and each leg was tested.
Time Frame
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)]
Title
Change in proactive balance
Description
Functional reach test (FR) will be used (cm). Is a measure of the distance in centimeters that the standing participant is able to reach forward from an initial upright posture to the maximal anterior leaning posture without moving or lifting the feet.
Time Frame
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)]
Title
Falls during the study
Description
The number of falls of each subject during the study will be counted
Time Frame
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)]
Title
Change in the Broadband ultrasound attenuation (BUA) as secondary parameter of bone health
Description
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcome we will assess the Broadband ultrasound attenuation (BUA) (dB/MHz). It is a measurement of the differential attenuation of sound waves transmitted through the calcaneus.
Time Frame
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)]
Title
Change in the Speed of sound (SOS) as secondary parameter of bone health
Description
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcomes we will assess the SOS through the calcaneus bone (m/s). It is calculated as the ratio of the distance traveled by the impulse and the time taken by the signal to travel that distance
Time Frame
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)]
Title
Change in the Quantitative ultrasound index (QUI) as secondary parameter of bone health
Description
Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As secondary outcomes we will assess the Quantitative ultrasound index. To improve precision we will calculate de QUI, a variable derived from the mathematical combination of both SoS and BUA [0.41 × (BUA + SoS) - 571] (19), expressed as percent.
Time Frame
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)]
Title
Change in the nutritional status
Description
Nutritional status will be assessed by the Mini Nutritional Assessment (MNA) (points). Total score ranging from 0 to 30. Well nourished (MNA score >23.5), at risk of malnutrition (MNA score=17.0-23.5), or malnourished (MNA score <17).
Time Frame
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)]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Méndez-Sánchez, PhD
Phone
(34)923294400
Ext
3201
Email
ro_mendez@usal.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Méndez-Sánchez, PhD
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32957420
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.
Results Reference
derived
Learn more about this trial
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease
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