Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Spanish Society of Diabetes | UNKNOWN |
| University of Castilla-La Mancha | OTHER |
| Castilla-La Mancha Health Service | OTHER |
Not provided
Not provided
Not provided
Not provided
Diabetes is a disease with a high impact in the population older than 65 years old. Some indications suggest that diabetes in the old age aggravate the negative effects of ageing, as the loss of muscle mass and strength, bringing the patients to a situation of vulnerability and elevated risk of disability and death known as "frailty syndrome". Recently, scientists have observed that if older population train with musculation machines emphasising the muscular power, it is possible to have an impact on a disminution of frailty and restoring the physical functionality. This project deeps in the physiological and molecular mechanisms that underlie to improvements in the frail diabetic patients.
It is hypothesised that:
The principal aims are:
Study design Longitudinal intervention stratified study, controlled and single-blinded, with a group of intervention and control group.
Based on data from a previous study recently published by the collaborators of this project. The sample size was calculated to get statistically significant differences in the physical functionality using ANCOVA and performing a bilateral contrast with alpha=0.05 of the effect of the group (with any of the independent variables), and it is needed 30 subjects by group (total n=60) to get a statistical power of 80%, with a partial eta ≥ 0.101 (value that corresponds with the size of the moderate effect).
Exercise program The intervention period will have a duration of 12 weeks, in which the training group will perform 2 sessions per week (24 sessions in total), while the control group will not perform any type of intervention, following their normal lifes and the habitual medical cares. The experimental group will perform a program focused on the muscle power training, in which there will be included exercise of upper limbs (chest press) and lower limbs (leg press). The exercises will be performed in muscle-building machines available in the reference institutions of the collaborators. It is important to point out that the intensity in the exercises will be individualised for any patient through a test of determination of muscle power validated previously by the consortium of researchers and the subjects will perform the exercises at this intensity at which the subjects will develop their maximal muscle performance, with the performance of 3-4 bouts of 8 repetitions in each exercise. After the third week of intervention, it will be put the attention to the speed of execution. The duration of each session has been estimated in 20-30 minutes.
Finally, the subjects in the control group will serve to compare the interventions with exercise and the clinical conventional treatment, as well as to determine whether the training program is able to restore the functional capacity in a similar way in diabetic patients without frailty.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Power training group | Experimental | Participants will be enrolled in a resistance training program. |
|
| Control group | No Intervention | Participants will be doing their normal life. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Power resistance training | Other | Participants will take part in an intervention of 12 weeks duration in which they will train with musculation machines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Glycosylated Hemoglobin (Hemoglobin A1c) at 12 weeks | Percentage | 0 and 12 weeks. |
| Change from Baseline Homeostasis Model Assessment - Beta cells (HOMA2-B) at 12 weeks | Percentage | 0 and 12 weeks. |
| Change from Baseline Homeostasis Model Assessment - Insuline Resistance (HOMA2-IR) at 12 weeks | Percentage | 0 and 12 weeks. |
| Change from Baseline Fried frailty score at 6 and 12 weeks | Level of frailty assessed by Fried Criteria. Intermediate or prefrail: 1 or 2 criteria present. Positive for frailty phenotype: ≥3 criteria present. | 0, 6 and 12 weeks. |
| Change from Baseline Functional capacity at 6 and 12 weeks | Level of functional capacity assessed by the test SPPB. Scores 0-3: Very low physical function; Scores 4-6: Low physical function; Scores 7-9: Moderate physical function; Scores 10-12: High physical function | 0, 6 and 12 weeks. |
| Change from Baseline Disability at 6 and 12 weeks | Level of disability assessed by the Barthel test. A participant scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. | 0, 6 and 12 weeks. |
| Functional mobility at 6 and 12 weeks | Level of functional mobility assessed by the Lawton test. A scale from 0 to 8, expressing higher scores better levels of independence. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Body Mass Index at 6 and 12 weeks | Kg by square meters. | 0, 6 and 12 weeks. |
| Change from Baseline Waist circumference at 6 and 12 weeks | Meters. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amelia Guadalupe Grau, PhD | Technical University of Madrid | Principal Investigator |
| Carmen RamÃrez Castillejo, PhD | Technical University of Madrid | Study Chair |
| Marcela González Gross, Professor | Technical University of Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Educación FÃsica | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26163682 | Background | Guadalupe-Grau A, Carnicero JA, Gomez-Cabello A, Gutierrez Avila G, Humanes S, Alegre LM, Castro M, Rodriguez-Manas L, Garcia-Garcia FJ. Association of regional muscle strength with mortality and hospitalisation in older people. Age Ageing. 2015 Sep;44(5):790-5. doi: 10.1093/ageing/afv080. Epub 2015 Jul 11. | |
| 24598478 | Background |
Not provided
Not provided
Individualised report to all the participants after the completion of the study.
At the end of the intervention.
The participants who have accepted to have the report.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2019 | Mar 30, 2020 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 0, 6 and 12 weeks. |
| Change from Baseline Muscular power at 6 and 12 weeks | Watts. | 0, 6 and 12 weeks. |
| Change from Baseline Levels of strength at 6 and 12 weeks | Load (kg). | 0, 6 and 12 weeks. |
| Change from Baseline Bone Mineral Density at 12 weeks | g/cm3 | 0 and 12 weeks. |
| Change from Baseline Pigment Epitelium Derived Factor (PEDF) at 12 weeks | Circulating level of PDEF assessed by Western Blot. | 0 and 12 weeks. |
| Genotyping of TCF7L2 (rs7903146) | Assessed by Real-time PCR. | 0 week. |
| Genotyping of TM6SF2 (rs10401969) | Assessed by Real-time PCR. | 0 week. |
| Genotyping of HLA (rs2854275) | Assessed by Real-time PCR. | 0 week. |
| 0, 6 and 12 weeks. |
| Change from Baseline Blood pressure (systolic and diastolic) at 6 and 12 weeks | mmHg. | 0, 6 and 12 weeks. |
| Change from Baseline Concentration of Triglycerides at 12 weeks | mg/dL. | 0 and 12 weeks. |
| Change from Baseline Concentration of Total Cholesterol at 12 weeks | mg/dL. | 0 and 12 weeks. |
| Change from Baseline Concentration of HDL Cholesterol at 12 weeks | mg/dL. | 0 and 12 weeks. |
| Change from Baseline Concentration of LDL Cholesterol at 12 weeks | mg/dL. | 0 and 12 weeks. |
| Change from Baseline Subjective level of quality of life at 12 weeks | Level of quality of life assessed by the test EuroQoL index, EQ-5D-5L. The score is the time trade-off (TTO). Scale from 11111 to 55555 being the higher the best health related quality of life. | 0 and 12 weeks. |
| Change from Baseline Physical activity at 12 weeks | Accelerometry, counts/min. | 0 and 12 weeks. |
| Change from Baseline Balance at 12 weeks | Level of balance assessed in a force platform. Newtons. | 0 and 12 weeks. |
| Garcia-Garcia FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Manas L. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2. |
| 22159772 | Background | Garcia-Garcia FJ, Gutierrez Avila G, Alfaro-Acha A, Amor Andres MS, De Los Angeles De La Torre Lanza M, Escribano Aparicio MV, Humanes Aparicio S, Larrion Zugasti JL, Gomez-Serranillo Reus M, Rodriguez-Artalejo F, Rodriguez-Manas L; Toledo Study Group. The prevalence of frailty syndrome in an older population from Spain. The Toledo Study for Healthy Aging. J Nutr Health Aging. 2011 Dec;15(10):852-6. doi: 10.1007/s12603-011-0075-8. |
| 30528641 | Background | Losa-Reyna J, Baltasar-Fernandez I, Alcazar J, Navarro-Cruz R, Garcia-Garcia FJ, Alegre LM, Alfaro-Acha A. Effect of a short multicomponent exercise intervention focused on muscle power in frail and pre frail elderly: A pilot trial. Exp Gerontol. 2019 Jan;115:114-121. doi: 10.1016/j.exger.2018.11.022. Epub 2018 Dec 4. |
| 29567100 | Background | Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Rodriguez-Gomez I, Navarro-Cruz R, Losa-Reyna J, Garcia-Garcia FJ, Alegre LM. Force-velocity profiling in older adults: An adequate tool for the management of functional trajectories with aging. Exp Gerontol. 2018 Jul 15;108:1-6. doi: 10.1016/j.exger.2018.03.015. Epub 2018 Mar 20. |
| 29309534 | Background | Alcazar J, Guadalupe-Grau A, Garcia-Garcia FJ, Ara I, Alegre LM. Skeletal Muscle Power Measurement in Older People: A Systematic Review of Testing Protocols and Adverse Events. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):914-924. doi: 10.1093/gerona/glx216. |
| 29126339 | Background | Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Manas-Bote A, Guadalupe-Grau A, Garcia-Garcia FJ, Alegre LM. The Force-Velocity Relationship in Older People: Reliability and Validity of a Systematic Procedure. Int J Sports Med. 2017 Dec;38(14):1097-1104. doi: 10.1055/s-0043-119880. Epub 2017 Nov 10. |
| 27402660 | Background | Guadalupe-Grau A, Aznar-Lain S, Manas A, Castellanos J, Alcazar J, Ara I, Mata E, Daimiel R, Garcia-Garcia FJ. Short- and Long-Term Effects of Concurrent Strength and HIIT Training in Octogenarians with COPD. J Aging Phys Act. 2017 Jan;25(1):105-115. doi: 10.1123/japa.2015-0307. Epub 2016 Aug 24. |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |