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| Name | Class |
|---|---|
| Università degli Studi di Ferrara | OTHER |
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The aim of the study is to investigate the effectiveness of three different types of intervention, based on physical exercise and/or cognitive stimulation or training, on quality of life, cognition and mobility, on a population of older adults, who are most at risk of functional and cognitive decline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured Exercise Program + Cognitive training | Experimental | In addition to the exercise program, participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants. |
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| Structured Exercise Program + Cognitive stimulus | Experimental | In addition to the exercise program, people will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options. |
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| Structured Exercise Program | Active Comparator | The program includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching. The exercise program will be the same for all the three groups |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | Behavioral | The program includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life assessed by the short-form 36 (SF-36) questionnaire | This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks. For each specific domain, the score ranges from 0 (lowest quality of life) to 100 (highest quality of life). | Baseline; end of the program (3-month); Follow-up (6-month) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire | QOL-AD consists of 13 questions covering various aspects of daily life, such as physical health, energy, mood, relationships and the ability to enjoy enjoyable activities. The combined scores of the patient and caregiver provide a more comprehensive and accurate picture of the person's overall well-being. The scale has a score ranging from 13 (lowest quality of life) to 52 (highest quality of life). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Pomidori Principal Investigator, PhD | Contact | 00393455984607 | luca.pomidori@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Esercizio Vita | Recruiting | Ferrara | 44124 | Italy |
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|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | Behavioral | In addition to the exercise program, Participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants. |
|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | Behavioral | In addition to the exercise training, people will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options. |
|
| Baseline; end of the program (3-month); Follow-up (6-month) |
| Cognitive capacity assessed by the Montreal Cognitive Assessment (MoCA) | MoCA is a 30-point test evaluates cognitive function. Its primary purpose is to detect mild cognitive impairment (MCI). The score goes from 0 (maximal cognitive deficit) to 30 (normal cognitive function). | Baseline; end of the program (3-month); Follow-up (6-month) |
| Executive function and processing speed assessed by the Trail Making Test (TMT) | TMT is neuropsychological test that assesses a person's cognitive function, specifically focusing on visual attention, processing speed, and executive function. The test consists of two parts, the score is based on the time it takes to complete each part, with shorter times indicating better performance. | Baseline; end of the program (3-month); Follow-up (6-month) |
| Walking endurance assessed by the 6-Minute Walking Test (6MWT) | The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters | Baseline; end of the program (3-month); Follow-up (6-month) |
| Short Physical Performance Battery (SPPB) | It is a specific assessment for the elderly population, consisting of three functional tests that measure postural stability, the ability to walk safely, and lower limb muscle strength. Higher scores indicate better functional ability. The scale goes from 0 (lowest functional ability) to 12 (highest functional ability). | Baseline; end of the program (3-month); Follow-up (6-month) |
| Manual grip strength using the Handgrip Test (HT) | The test is performed using a dynamometer: the subject grabs the handle of the device with maximum strength, and the maximum value of force expressed in kilograms is recorded. | Baseline; end of the program (3-month); Follow-up (6-month) |
| Sleep quality through the Pittsburgh Sleep Quality Index (PSQI) | It refers to the last 30 days and analyses seven components. The total score ranges from 0 to 21. A score above 5 indicates poor sleep quality. | Baseline; end of the program (3-month); Follow-up (6-month) |
| Timed Up-and-Go test | This test ask the participant to stand up from a standard chair, walk for three meters, turn around a cone and get back to the starting point and seating. The total timed elapsed will be collected | Baseline; end of the program (3-month); Follow-up (6-month) |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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