Effectiveness of a Multi-component Physical Training in Hyper-fragile Elders: A Randomized Clinical Trial

Study Overview
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Brief Summary
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Objective: To compare short-term and medium-term effectiveness of a multimodal program that integrates a program of therapeutic exercise, medication review, adequacy of diet and health education, compared with standard medical practice in improving neuromuscular and physiological status on frail elderly. Another aim is to analyze the maintenance of these effects by monitoring long-term (12 months) from the start of the intervention. Design: Randomized controlled trial Scope / Study subjects: recruited frail elderly in Basic Health Zone of Malaga. Methods: The subjects to be included in the study (after meeting inclusion / exclusion) will be randomized into two groups: a control group whose intervention will be to review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles) and an experimental group whose intervention will be a Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program. Sociodemographic, Clinical and monitoring Variables will be collected at baseline. Moreover, tracking variables will be collected at 2 and 6 months after starting the intervention and at 3 and 6 months after the end of the intervention (monitoring). The monitoring variables that will be measured are: BMI , general health, fatigue, brittleness, Motor Control, Attention - Concentration - Memory, Motor Memory , spatial orientation, grip strength, balance (static - semi-static and dynamic ), gait speed and metabolomic variables. One descriptive analysis of the sociodemographic variables of the participants will be performed. Further the change on the variables intra-subjects (pre-post intervention) and inter-subjects (experimental group vs control group) will be calculated. For the intra-subject analysis will be performed a ANOVA-one factor analysis. The intersubject outcome variables will be compared between the two groups in each moments of data collection, using the student t-test or Wilconxon (depending of the sample distribution). The level of significance was set at P ≤ 0.05.

Official Title
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Effectiveness of a Multi-componentphysical Training Integrated Into a Multimodal Program Based on the Evidence in Hiper-fragile Elders: A Randomized Clinical Trial STUDY POWER_AGING

Conditions
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Multimodal Intervention, Fragility, Other Metabolic Diseases, Physical Activity, Patient Fall, Dietary Modification

Intervention / Treatment
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* Other: Control Intervention
* Other: Multimodal Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People 65 years older than after screening of fragility as the test battery Short Physical Performance Battery (SPPB), can perform the therapeutic exercise program Exclusion Criteria: Presence in the medical history of neuromuscular , metabolic, hormonal and / or cardiovascular disorders.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>a control group whose intervention will be to review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles) | Other: Control Intervention<br>* Control Intervention: review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles)<br>|
| Experimental: Experimental Group<br>Experimental group whose intervention will be a Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program. | Other: Multimodal Intervention<br>* Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | The measurements will be taken following the anthropometric parameter guidelines of The International Society for the Advancement of Kinanthropometry (ISAK) (Ross et al., 1978). | Baseline - 6 months after the end of the intervention | 
| Health Related Quality of Life SF-12 | General health condition was measured using the SF-12 short form questionnaire, adapted from the extended SF-36 version. Both physical and mental components are evaluated. The higher the score the better the condition. SF-12 reliability has proven a high internal consistency demonstrating an approximate ICC (Intraclass Correlation Coefficient) of 0.9. (Vigalut et al., 2008). | Baseline - 6 months after the end of the intervention | 
| Fatigue State POMS (Profile of Mood States) | The Spanish version of POMS published by Andrade et al. (2010) was used, with 44 items that represented six conceptual dimensions: anger (11 items), fatigue (6 items), vigour (5 items), friendship (6 items), stress (7 items) and depressed state (9 items). As usual, the answer format consisted of a 5 ordered category response, assigned with values 0 (nothing) to 4 (a lot). All the items were put forward in the same trend except for the item 29-relaxed (corresponding to the state of stress) scores, that were inverted after the test. | Baseline - 6 months after the end of the intervention | 
| Frailty Questionnaire | The auto-administrated survey based in 10 dichotomous questions in order to detect elder frail people will be carried out (Di Bari et al.2014). | Baseline - 6 months after the end of the intervention | 
| MMSE (Mini-Mental State Examination) - MEC-30 (Mini Cognitive Examination | The MEC consists of 30 items grouped into 11 sections (Fig. 1), the clinician could carry out in 5-15 min based on the following indications; note that those responsible for carrying out this instrument, both in its original version (Folstein) and its Spanish adaptation (Lobo et al, 2002), warn that the professional should stick to these criteria as far as possible, ensuring maximum objectivity in registering the subject's responses. The eleven sections are: Orientation to time, Orientation to space, Registration, Attention and Calculation, Memory, Nomination, Repetition (Recall), Comprehension, Reading, Writing and Drawing. | Baseline - 6 months after the end of the intervention | 
| Motor memory test | Motor skill memory and body awareness will be measured directing a test that consists of performing ten static positions. The examiner executes 10 positions holding each one of them for 10 seconds. Immediately after, the patient imitates the position in the opposite way, analogous to a mirror. The test ends when the 10 positions have been carried out. This test is included in the Memory in movement program, used as a cognitive intervention tool (Rey Cao, Canales Lacruz, Táboas País, & Cancela Carra, 2008). | Baseline - 6 months after the end of the intervention | 
| Spatial orientation test | The SODT-R (Spatial Orientation Dynamic Test-Revised, SODT-R, Colom, Contreras, Shih and Santacreu, 2003) task is to direct two moving objects to a given destination. There are two buttons for each of the moving objects in order to control their course, as shown in Figure 1. Pressing the buttons changes the object's course in one direction, reducing or increasing the angular discrepancy between the current course compared to the ideal course that would stand for 0 deviation. | Baseline - 6 months after the end of the intervention | 
| Grip strength test | Hand grip strength test will examine the peak of strength and fatigue resistance. The test is performed with the participant in a sitting position and 90 degree elbow flexion, neutral pronosupination and flexion, extension or inclination of the wrist will not be allowed. The patient will be asked to hand grip, which will be evaluated with a hydraulic dynamometer JAMAR (Bellace, Healy, Besser, Byron, & Hohman, 2000). | Baseline - 6 months after the end of the intervention | 
| Balance (static - semi-static and dynamic) test | Expanded TUG is a test to assess mobility, balance and risk of falls in the elderly. (Podsiadlo and Richardson, 2015). The test consists of timing how long the seated patient takes to get up, walk ten metres, return and sit back again on the chair. | Baseline - 6 months after the end of the intervention |