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
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in gait and balance 2
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Multicomponent physical exercise program associated with a Mediterranean diet (Other)
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.
干预措施: Usual care (Other)
结局指标
主要结局
Change in gait and balance 2
时间窗: 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)]
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 gait and balance 1
时间窗: 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)]
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 Bone Mineral Density (BMD)
时间窗: 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)]
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
时间窗: 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)]
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.
次要结局
- 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)])
- 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)])
- 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 Quantitative ultrasound index (QUI) 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)])
- 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 nutritional status(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)])
研究者
Roberto Méndez Sánchez
Professor
University of Salamanca