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

Primary outcomes

1. Body mass index

   Time frame: Baseline - 6 months after the end of the intervention

   The measurements will be taken following the anthropometric parameter guidelines of The International Society for the Advancement of Kinanthropometry (ISAK) (Ross et al., 1978).

2. Health Related Quality of Life SF-12

   Time frame: Baseline - 6 months after the end of the intervention

   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).

3. Fatigue State POMS (Profile of Mood States)

   Time frame: Baseline - 6 months after the end of the intervention

   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.

4. Frailty Questionnaire

   Time frame: Baseline - 6 months after the end of the intervention

   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).

5. MMSE (Mini-Mental State Examination) - MEC-30 (Mini Cognitive Examination

   Time frame: Baseline - 6 months after the end of the intervention

   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.

6. Motor memory test

   Time frame: Baseline - 6 months after the end of the intervention

   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).

7. Spatial orientation test

   Time frame: Baseline - 6 months after the end of the intervention

   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.

8. Grip strength test

   Time frame: Baseline - 6 months after the end of the intervention

   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).

9. Balance (static - semi-static and dynamic) test

   Time frame: Baseline - 6 months after the end of the intervention

   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.